Trial Outcomes & Findings for A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202) (NCT NCT03597295)

Last Updated: 2025-08-21

Results Overview

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

94 participants

Primary outcome timeframe

Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

Results posted on

2025-08-21

Participant Flow

This study was conducted at 40 study centers: 32 in France, 19 in the United Kingdom, 10 in Italy, 10 in Spain, 7 in Denmark, 6 in the United States, 4 in Norway, 4 in Belgium, and 2 in Germany.

A total of 94 participants with locally advanced or metastatic squamous carcinoma of the anal canal were enrolled in the study and treated with retifanlimab.

Participant milestones

Participant milestones
Measure	Retifanlimab 500 mg Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Overall Study STARTED	94
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	77

Reasons for withdrawal

Reasons for withdrawal
Measure	Retifanlimab 500 mg Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Overall Study Death	70
Overall Study Lost to Follow-up	7

Baseline Characteristics

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retifanlimab 500 mg n=94 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Age, Continuous	62.1 Years STANDARD_DEVIATION 11.44 • n=99 Participants
Sex: Female, Male Female	61 Participants n=99 Participants
Sex: Female, Male Male	33 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=99 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	49 Participants n=99 Participants
Race/Ethnicity, Customized Not Reported	11 Participants n=99 Participants
Race/Ethnicity, Customized Unknown	4 Participants n=99 Participants
Race/Ethnicity, Customized Missing	6 Participants n=99 Participants
Race/Ethnicity, Customized White/Caucasian	72 Participants n=99 Participants
Race/Ethnicity, Customized Black/African-American	1 Participants n=99 Participants
Race/Ethnicity, Customized Captured as "Other"	4 Participants n=99 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of study drug

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=94 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Objective Response Rate (ORR)	13.8 percentage of participants

SECONDARY outcome

Timeframe: up to 18.2 months

Population: Full Analysis Set. All participants with confirmed tumor responses (CR or PR) by ICR according to RECIST v1.1 were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.

DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=13 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Duration of Response (DOR)	9.5 months Interval 4.4 to The upper limit of the confidence interval was not estimable because too few participants had disease progression or died

SECONDARY outcome

Timeframe: Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

Population: Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.

DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, at any post-baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=94 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Disease Control Rate (DCR)	48.9 percentage of participants Interval 38.5 to 59.5

SECONDARY outcome

Timeframe: up to 16.8 months

Population: Full Analysis Set. Median PFS time was estimated using the Kaplan-Meier method. The confidence interval for median PFS time was calculated using the method of Brookmeyer and Crowley.

According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, as determined by ICR, or death due to any cause, if occurring sooner than progression.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=94 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Progression-free Survival (PFS)	2.3 months Interval 1.9 to 3.6

SECONDARY outcome

Timeframe: up to 28.2 months

Population: Full Analysis Set. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=94 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Overall Survival	13.4 months Interval 10.1 to 15.0

SECONDARY outcome

Timeframe: up to 913 days

Population: Safety Evaluable Population: all enrolled participants who received at least 1 dose of study drug

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=94 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	90 Participants

SECONDARY outcome

Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6

Population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and provided a Baseline and at least 1 postdose serum sample (1 PK measurement)

Cmax was defined as the maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=92 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Cmax of Retifanlimab	151 milligrams per Liter (mg/L) Standard Deviation 27.6

SECONDARY outcome

Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6

Population: PK Evaluable Population

tmax was defined as the time to the maximum concentration.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=92 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Tmax of Retifanlimab	1.20 hours Standard Deviation 0.305

SECONDARY outcome

Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6

Population: PK Evaluable Population

Cmin was defined as the minimum observed plasma concentration over the dose interval.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=92 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Cmin of Retifanlimab	22.4 mg/L Standard Deviation 7.87

SECONDARY outcome

Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6

Population: PK Evaluable Population

AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Outcome measures

Outcome measures
Measure	Retifanlimab 500 mg n=92 Participants Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
AUC0-t of Retifanlimab	1950 day*mg/L Standard Deviation 594

Adverse Events

Retifanlimab 500 mg

Serious events: 50 serious events

Other events: 79 other events

Deaths: 60 deaths

Serious adverse events

Serious adverse events
Measure	Retifanlimab 500 mg n=94 participants at risk Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Infections and infestations Anal abscess	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Asthenia	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Investigations Blood bilirubin increased	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Investigations Body temperature increased	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Musculoskeletal and connective tissue disorders Bone pain	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Catheter site pain	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Cellulitis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Abdominal pain	4.3% 4/94 • Number of events 4 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Renal and urinary disorders Acute kidney injury	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Endocrine disorders Adrenal insufficiency	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Blood and lymphatic system disorders Anaemia	4.3% 4/94 • Number of events 4 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Hepatobiliary disorders Cholangitis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Hepatobiliary disorders Cholecystitis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Hepatobiliary disorders Cholecystitis acute	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Nervous system disorders Cognitive disorder	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Colonic fistula	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Nervous system disorders Coma hepatic	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Constipation	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Metabolism and nutrition disorders Decreased appetite	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Metabolism and nutrition disorders Dehydration	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Device related infection	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Diarrhoea	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 2/94 • Number of events 2 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Injury, poisoning and procedural complications Fall	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Injury, poisoning and procedural complications Femur fracture	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Musculoskeletal and connective tissue disorders Flank pain	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Gastric ulcer	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Gastroenteritis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders General physical health deterioration	3.2% 3/94 • Number of events 3 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Renal and urinary disorders Haematuria	2.1% 2/94 • Number of events 2 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Nervous system disorders Headache	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Hepatobiliary disorders Hepatitis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Herpes zoster	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Renal and urinary disorders Hydronephrosis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Metabolism and nutrition disorders Hypercalcaemia	2.1% 2/94 • Number of events 2 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Ileus	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Immune-mediated enterocolitis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Inadequate analgesia	2.1% 2/94 • Number of events 2 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Intestinal obstruction	2.1% 2/94 • Number of events 2 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Large intestinal obstruction	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Lyme disease	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Psychiatric disorders Mental status changes	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Nausea	2.1% 2/94 • Number of events 4 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Pain	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Pelvic infection	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Reproductive system and breast disorders Pelvic pain	3.2% 3/94 • Number of events 3 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Peritonitis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 2/94 • Number of events 3 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Pneumocystis jirovecii pneumonia	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Pneumonia	2.1% 2/94 • Number of events 2 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Proctalgia	2.1% 2/94 • Number of events 3 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Proctitis haemorrhagic	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Pseudomonas infection	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Skin and subcutaneous tissue disorders Purpura	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Pyrexia	3.2% 3/94 • Number of events 3 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Rectal haemorrhage	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Sepsis	2.1% 2/94 • Number of events 2 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Skin infection	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Stoma site infection	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Superior mesenteric artery syndrome	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Vascular disorders Thrombosis	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour embolism	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Renal and urinary disorders Ureteric compression	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Renal and urinary disorders Urinary retention	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Urinary tract infection	4.3% 4/94 • Number of events 4 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Vascular disorders Venous thrombosis limb	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Vomiting	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Investigations Weight decreased	1.1% 1/94 • Number of events 1 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.

Other adverse events

Other adverse events
Measure	Retifanlimab 500 mg n=94 participants at risk Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Gastrointestinal disorders Abdominal pain	7.4% 7/94 • Number of events 7 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Blood and lymphatic system disorders Anaemia	16.0% 15/94 • Number of events 19 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 8/94 • Number of events 10 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Investigations Aspartate aminotransferase increased	7.4% 7/94 • Number of events 7 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Asthenia	23.4% 22/94 • Number of events 31 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Musculoskeletal and connective tissue disorders Back pain	8.5% 8/94 • Number of events 9 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Constipation	12.8% 12/94 • Number of events 14 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Respiratory, thoracic and mediastinal disorders Cough	11.7% 11/94 • Number of events 13 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Cystitis	5.3% 5/94 • Number of events 5 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Metabolism and nutrition disorders Decreased appetite	12.8% 12/94 • Number of events 12 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Diarrhoea	21.3% 20/94 • Number of events 32 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.7% 11/94 • Number of events 13 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Fatigue	18.1% 17/94 • Number of events 21 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Nervous system disorders Headache	8.5% 8/94 • Number of events 9 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Metabolism and nutrition disorders Hypokalaemia	5.3% 5/94 • Number of events 5 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Endocrine disorders Hypothyroidism	9.6% 9/94 • Number of events 10 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Psychiatric disorders Insomnia	6.4% 6/94 • Number of events 6 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Nausea	16.0% 15/94 • Number of events 21 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Proctalgia	7.4% 7/94 • Number of events 7 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Skin and subcutaneous tissue disorders Pruritus	11.7% 11/94 • Number of events 14 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
General disorders Pyrexia	10.6% 10/94 • Number of events 18 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Skin and subcutaneous tissue disorders Rash	5.3% 5/94 • Number of events 6 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Rectal haemorrhage	9.6% 9/94 • Number of events 17 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Infections and infestations Urinary tract infection	7.4% 7/94 • Number of events 9 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Gastrointestinal disorders Vomiting	14.9% 14/94 • Number of events 18 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.
Investigations Weight decreased	8.5% 8/94 • Number of events 8 • up to 913 days Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab, have been reported.

Additional Information

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