Trial Outcomes & Findings for PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (NCT NCT04382898)

Last Updated: 2025-03-20

Results Overview

DLT criteria were defined as following: any treatment-emergent adverse events (TEAE) of Grade 5 intensity; hematological toxicities (Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 and 4 hemorrhage associated with thrombocytopenia of Grade greater than or equal to \[\>=\] 3, Grade 4 anemia); and non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\], Grade 3 CRS which has not improved to Grade 1 or resolved within 48 hours; any Grade \>=3 non-hematological TEAE at least possibly related which occurs during the first BNT112 cancer vaccine treatment cycle).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Cycle 1 (21 days)

Results posted on

2025-03-20

Participant Flow

The trial consisted of 2 parts: Part 1 (dose titration) and Part 2 (dose expansion; consisted of four arms).

Part 1 and Part 2 (Arms 1A and 1B) enrolled participants with metastatic castration-resistant prostate cancer (mCRPC). Part 2: Arms 2 and 3 enrolled participants with newly diagnosed high-risk localized prostate cancer (LPC). A total of 75 participants (9 participants in Part 1 and 66 in Part 2) were enrolled in this study. All participants in Part 1 and Part 2 received the same dose of cemiplimab.

Participant milestones

Participant milestones
Measure	Part 1 (mCRPC): BNT112 Participants with mCRPC received intravenous (IV) administration of BNT112 (cumulative doses ranged from 100 to 1175 micrograms \[mcg\]) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter every 3 weeks (Q3W) starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk, localized prostate cancer (LPC) received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Part 1: Dose Titration STARTED	9	0	0	0	0
Part 1: Dose Titration COMPLETED	2	0	0	0	0
Part 1: Dose Titration NOT COMPLETED	7	0	0	0	0
Part 2: Dose Expansion STARTED	0	28	27	5	6
Part 2: Dose Expansion COMPLETED	0	10	9	4	5
Part 2: Dose Expansion NOT COMPLETED	0	18	18	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 (mCRPC): BNT112 Participants with mCRPC received intravenous (IV) administration of BNT112 (cumulative doses ranged from 100 to 1175 micrograms \[mcg\]) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter every 3 weeks (Q3W) starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk, localized prostate cancer (LPC) received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Part 1: Dose Titration Withdrawal by Subject	1	0	0	0	0
Part 1: Dose Titration Death	6	0	0	0	0
Part 2: Dose Expansion Withdrawal by Subject	0	0	1	0	0
Part 2: Dose Expansion Lost to Follow-up	0	0	1	0	0
Part 2: Dose Expansion Death	0	17	13	1	0
Part 2: Dose Expansion Progressive Disease	0	0	1	0	0
Part 2: Dose Expansion Study Terminated By Sponsor	0	1	1	0	1
Part 2: Dose Expansion Other	0	0	1	0	0

Baseline Characteristics

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 (mCRPC): BNT112 n=9 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=28 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 n=27 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab n=5 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 n=6 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Total n=75 Participants Total of all reporting groups
Age, Customized < 50 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Age, Customized >= 50 - < 65 years	1 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants	3 Participants n=7 Participants	4 Participants n=31 Participants	26 Participants n=30 Participants
Age, Customized >= 65 - < 85 years	8 Participants n=99 Participants	20 Participants n=107 Participants	16 Participants n=206 Participants	2 Participants n=7 Participants	2 Participants n=31 Participants	48 Participants n=30 Participants
Age, Customized >= 85 years	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	28 Participants n=107 Participants	27 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	75 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	4 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	4 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	23 Participants n=107 Participants	27 Participants n=206 Participants	4 Participants n=7 Participants	6 Participants n=31 Participants	69 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	2 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	1 Participants n=31 Participants	5 Participants n=30 Participants
Race (NIH/OMB) White	8 Participants n=99 Participants	27 Participants n=107 Participants	26 Participants n=206 Participants	3 Participants n=7 Participants	5 Participants n=31 Participants	69 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 days)

Population: Analysis was performed on the DLT evaluation set that included all participants who received IMP and completed the DLT evaluation period and met the minimum exposure criterion or experienced a DLT during Cycle 1. Data for this outcome measure was not planned to be collected and analyzed for Part 2 arms.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=9 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arms 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month)

Population: Analysis was performed on safety set that included all participants who received at least 1 dose of the IMP.

TEAE: any adverse event (AE) with an onset date on or after the first administration of investigational medicinal product (IMP) or worsened after first administration of IMP. AEs with an onset date more than 30 days after last dose of BNT112 or 90 days after last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) were only considered as TEAEs if assessed as related to IMP by the investigator. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect or was another medically important condition. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0), where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; Grade 5: Death related to AE.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=9 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=28 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 n=27 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab n=5 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 n=6 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure Serious TEAE	5 Participants	5 Participants	9 Participants	2 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure Grade >= 3 TEAEs	7 Participants	15 Participants	15 Participants	1 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure Grade 5 TEAEs	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure TEAEs related to trial procedure	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure TEAEs	8 Participants	28 Participants	26 Participants	5 Participants	6 Participants

PRIMARY outcome

Timeframe: From start of treatment up to 46 weeks

Population: Analysis was performed on modified Intent to Treat population (mITT) population that included all participants who were randomized to the IMP and had a baseline and at least one post-baseline (i.e., one on-treatment or post-treatment) tumor assessment (clinical or imaging assessment). Data for this outcome measure was not planned to be collected and analyzed for Part 2: Arms 2 and 3.

ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as per Prostate Cancer Working Group 3 (PCWG3) criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=27 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Part 2 Arm 1a: Objective Response Rate (ORR)	0 percentage of participants Interval 0.0 to 12.8	—	—	—	—

PRIMARY outcome

Timeframe: From start of treatment up to 104 weeks

Population: Analysis was performed on mITT population. Data for this outcome measure was not planned to be collected and analyzed for Part 2: Arms 2 and 3.

ORR was defined as the percentage of participants with a CR or PR as per PCWG3 criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=25 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Part 2 Arm 1b: Objective Response Rate (ORR)	12.0 percentage of participants Interval 2.5 to 31.2	—	—	—	—

SECONDARY outcome

Timeframe: Day8 (Cycles1&2 only), Day1 Cycle 2 & Day 15 (Cycles1,2 & 8 only) (each cycle of 21-days), & EOT (30 days after last dose of BNT112 [Part 1 & Part 2 Arms 1b & 3] or 90 days after last dose of cemiplimab [Part 2, Arm 1a & Arm 2] [up to 4 years & 1 months])

Population: Analysis was performed on mITT population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category at respective visit and "0" in the number analyzed field signifies that no participants were available for analysis at the specified visit.

Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSA decline categories of No decline, 0 to 25%, \>25% to 50%, and \>50% compared to baseline during treatment according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=8 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=24 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 n=23 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab n=5 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 n=6 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 8: 0 to 25%	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 1: No decline	6 Participants	21 Participants	19 Participants	1 Participants	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 1: 0 to 25%	2 Participants	3 Participants	2 Participants	1 Participants	1 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 1: Greater than (>) 25% to 50%	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 8: No decline	1 Participants	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 8: No decline	—	—	—	—	1 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 8: Greater than (>) 25% to 50%	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 8: >50%	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 15: No decline	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 15: 0 to 25%	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 15: >25% to 50%	—	—	—	—	1 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 1 Day 15: >50%	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 1: >50%	0 Participants	0 Participants	1 Participants	3 Participants	4 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 8: 0 to 25%	0 Participants	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 8: > 25% to 50%	0 Participants	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 8: >50%	0 Participants	—	—	—	1 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 15: No decline	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 15: 0 to 25%	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 15: > 25% to 50%	—	—	—	—	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 2 Day 15: >50%	—	—	—	—	1 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 8 Day 15: No decline	—	—	1 Participants	—	—
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 8 Day 15: 0 to 25%	—	—	0 Participants	—	—
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 8 Day 15: > 25% to 50%	—	—	0 Participants	—	—
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Cycle 8 Day 15: >50%	—	—	0 Participants	—	—
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels EOT: No decline	7 Participants	17 Participants	19 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels EOT: 0 to 25%	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels EOT: > 25% to 50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels EOT: >50%	0 Participants	0 Participants	0 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Cycle 4 Day 1, Cycle 8 Day 1, Cycle 12 Day 1 (each cycle duration=21 days)

Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSADT was calculated using a linear regression model of the natural logarithm of PSA values and time. PSA doubling time compared to baseline during the treatment period for the following categories: 0 - 3 months; \>3 - 6 months; \>6 - 9 months; \>9 - 12 months; \>12 - 18 months; \>18 - 24 months; \>24 months and declining are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=6 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=21 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 n=19 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab n=5 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 n=6 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: >3 - 6 months	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: >6 - 9 months	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: >9 - 12 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: >12 - 18 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: >18 - 24 months	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: Declining	0 Participants	2 Participants	3 Participants	4 Participants	5 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: 0 - 3 months	3 Participants	6 Participants	8 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: >3 - 6 months	0 Participants	5 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: >6 - 9 months	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: >9 - 12 months	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: >12 - 18 months	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: > 24 months	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: Declining	0 Participants	1 Participants	2 Participants	5 Participants	6 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: >3 - 6 months	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: >9 - 12 months	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: >18 - 24 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: > 24 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: 0 - 3 months	5 Participants	16 Participants	11 Participants	1 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 4 Day 1: >24 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 8 Day 1: >18 - 24 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: 0 - 3 months	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: >6 - 9 months	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: >12 - 18 months	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Cycle 12 Day 1: Declining	0 Participants	1 Participants	2 Participants	4 Participants	3 Participants

SECONDARY outcome

Population: Analysis was performed on mITT population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit and "0" in the number analyzed field signifies that no participants were available for analysis at the specified visit.

Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. Participants with PSA decline of \>=50% compared to baseline according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=8 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=24 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 n=23 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab n=5 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 n=6 Participants Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Number of Participants With PSA Decline of >=50% Cycle 2 Day 1	0 Participants	0 Participants	1 Participants	3 Participants	4 Participants
Number of Participants With PSA Decline of >=50% EOT	0 Participants	0 Participants	0 Participants	4 Participants	3 Participants
Number of Participants With PSA Decline of >=50% Cycle 1 Day 8	—	—	—	—	0 Participants
Number of Participants With PSA Decline of >=50% Cycle 1 Day 15	—	—	—	—	0 Participants
Number of Participants With PSA Decline of >=50% Cycle 2 Day 8	0 Participants	—	—	—	1 Participants
Number of Participants With PSA Decline of >=50% Cycle 2 Day 15	—	—	—	—	1 Participants
Number of Participants With PSA Decline of >=50% Cycle 8 Day 15	—	—	0 Participants	—	—

SECONDARY outcome

Timeframe: From start of treatment up to 27 weeks

Population: Analysis was performed on mITT population. Data for this outcome measure was not planned to be collected and analyzed for Part 2: Arms 2 and 3.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=9 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Part 1: Objective Response Rate (ORR)	0 percentage of participants Interval 0.0 to 33.6	—	—	—	—

SECONDARY outcome

Timeframe: From start of treatment up to 25 weeks (Arm 2) and up to 26 weeks (Arm 3)

Population: Analysis was performed on mITT population. Data for this outcome measure was not planned to be collected and analyzed for Part 1 and Part 2: Arms 1a and 1b.

The best overall response was defined as a single best response status at any tumor response assessment after first administration of IMP and prior to or at the start date of the first subsequent anti-cancer therapy. Overall response of progressive disease within 14 days after the start date of first subsequent anti-cancer therapy was considered. The following order of tumor response categories were used, where "Complete Response" is the best category: Complete Response (CR) - Partial Response (PR) - Stable Disease (SD) - Progressive Disease (PD) - Not Evaluable (NE) - Missing. CR: disappearance of all target lesions, with reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR:30% decrease in the sum of the longest diameter of target lesions. PD: progression of target lesions (sum of diameter increase to nadir of \>=20% and by \>=5 mm), progression of existing non-target lesions, or appearance of 1 or more new lesions.SD: no evidence of PD, CR or PR.

Outcome measures

Outcome measures
Measure	Part 1 (mCRPC): BNT112 n=5 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=6 Participants Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment Complete Response (CR)	0 Participants	0 Participants	—	—	—
Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment Not Evaluable (NE)	0 Participants	0 Participants	—	—	—
Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment Missing	0 Participants	1 Participants	—	—	—
Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment Partial Response (PR)	3 Participants	3 Participants	—	—	—
Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment Stable Disease (SD)	2 Participants	2 Participants	—	—	—
Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment Progressive Disease (PD)	0 Participants	0 Participants	—	—	—

Adverse Events

Part 1 (mCRPC): BNT112

Serious events: 5 serious events

Other events: 8 other events

Deaths: 7 deaths

Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab

Serious events: 5 serious events

Other events: 28 other events

Deaths: 17 deaths

Part 2 (mCRPC): Arm 1b: BNT112

Serious events: 9 serious events

Other events: 26 other events

Deaths: 13 deaths

Part 2 (LPC): Arm 2: BNT112 + Cemiplimab

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Part 2 (LPC): Arm 3: BNT112

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 (mCRPC): BNT112 n=9 participants at risk Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=28 participants at risk Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 n=27 participants at risk Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab n=5 participants at risk Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 n=6 participants at risk Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Blood and lymphatic system disorders Anaemia	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Cardiac disorders Right ventricular failure	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Cardiac disorders Supraventricular tachycardia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Ear and labyrinth disorders Tinnitus	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Ileus	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Nausea	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Chest pain	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Fatigue	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Systemic inflammatory response syndrome	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Appendicitis perforated	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Pelvic abscess	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Sepsis	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Septic shock	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Urinary tract infection	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Electrocardiogram QT prolonged	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Paraesthesia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Spinal cord compression	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Syncope	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Haematuria	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Hydronephrosis	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Ureteric obstruction	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Urethral obstruction	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Vascular disorders Hypertension	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Vascular disorders Hypotension	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.

Other adverse events

Other adverse events
Measure	Part 1 (mCRPC): BNT112 n=9 participants at risk Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab n=28 participants at risk Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (mCRPC): Arm 1b: BNT112 n=27 participants at risk Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression.	Part 2 (LPC): Arm 2: BNT112 + Cemiplimab n=5 participants at risk Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 Q3W along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.	Part 2 (LPC): Arm 3: BNT112 n=6 participants at risk Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy.
Blood and lymphatic system disorders Anaemia	44.4% 4/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	28.6% 8/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.8% 4/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Cardiac disorders Atrial fibrillation	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Cardiac disorders Tachycardia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Ear and labyrinth disorders Tinnitus	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Endocrine disorders Hypothyroidism	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	11.1% 3/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Constipation	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	11.1% 3/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	22.2% 6/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Dry mouth	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Nausea	44.4% 4/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	21.4% 6/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	22.2% 6/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Stomatitis	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Toothache	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Gastrointestinal disorders Vomiting	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.8% 4/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Asthenia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Chest pain	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Chills	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	57.1% 16/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	22.2% 6/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	66.7% 4/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Fatigue	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	35.7% 10/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	18.5% 5/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders General physical health deterioration	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Influenza like illness	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	17.9% 5/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	18.5% 5/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	60.0% 3/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Injection site reaction	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Oedema peripheral	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
General disorders Pyrexia	66.7% 6/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	60.7% 17/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	59.3% 16/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Immune system disorders Cytokine release syndrome	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations COVID-19	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.3% 4/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	18.5% 5/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Coronavirus infection	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Oral herpes	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Infections and infestations Urinary tract infection	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Alanine aminotransferase increased	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Amylase increased	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Blood alkaline phosphatase increased	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.3% 4/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Blood creatinine increased	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Blood pressure increased	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations C-reactive protein increased	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Eastern Cooperative Oncology Group performance status worsened	33.3% 3/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Gamma-glutamyltransferase increased	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Lipase increased	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Platelet count decreased	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations SARS-CoV-2 test positive	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Investigations Weight decreased	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Decreased appetite	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Hyperkalaemia	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Metabolism and nutrition disorders Hypophosphataemia	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.3% 4/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	22.2% 6/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Back pain	22.2% 2/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.3% 4/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	11.1% 3/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Bone pain	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Mobility decreased	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.8% 4/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Dizziness	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Headache	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.4% 2/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	40.0% 2/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Neuropathy peripheral	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Presyncope	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Nervous system disorders Syncope	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Psychiatric disorders Anxiety	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Psychiatric disorders Insomnia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	10.7% 3/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Haematuria	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Pollakiuria	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Pyelocaliectasis	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Renal and urinary disorders Urinary incontinence	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	40.0% 2/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.3% 4/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.7% 1/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	3.6% 1/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	7.1% 2/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Skin and subcutaneous tissue disorders Urticaria	11.1% 1/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Vascular disorders Flushing	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	16.7% 1/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Vascular disorders Hot flush	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	33.3% 2/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Vascular disorders Hypertension	44.4% 4/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	14.3% 4/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	18.5% 5/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	20.0% 1/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	50.0% 3/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.
Vascular disorders Hypotension	0.00% 0/9 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/28 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	11.1% 3/27 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/5 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.	0.00% 0/6 • From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator. Analysis (including all-cause mortality) was performed on safety set. One participant in the Part 1 (mCRPC): BNT112 arm withdrew from the study 13 days after receiving their last dose and is reported in the participant flow section as having withdrawn from the study (based on the ITT population). However, the subject died within 30 days of their last dose so counted in the all-cause mortality for this arm which is based on the safety set.

Additional Information

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BioNTech SE

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Results disclosure agreements

Principal investigator is a sponsor employee The results of this trial may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
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