Trial Outcomes & Findings for A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma (NCT NCT04123470)

Last Updated: 2024-09-19

Results Overview

The AE reporting period begins upon receiving the first LOAd703 and/or atezolizumab treatment and continues until final visit at week 57

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Up to 57 weeks post treatment initiation

Results posted on

2024-09-19

Participant Flow

Overall, a total of 26 subjects signed the informed consent, 2 out of 26 subjects were screening failures and 24 out of 26 subjects were enrolled in the study.

Participant milestones

Participant milestones
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody
Group 1: LOAd703 Dose Level 1x10e11 VP STARTED	7	0
Group 1: LOAd703 Dose Level 1x10e11 VP COMPLETED	3	0
Group 1: LOAd703 Dose Level 1x10e11 VP NOT COMPLETED	4	0
Group 2: LOAd703 Dose Level 5x10e11 VP STARTED	0	17
Group 2: LOAd703 Dose Level 5x10e11 VP COMPLETED	0	8
Group 2: LOAd703 Dose Level 5x10e11 VP NOT COMPLETED	0	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody
Group 1: LOAd703 Dose Level 1x10e11 VP Death	4	0
Group 2: LOAd703 Dose Level 5x10e11 VP Withdrawal by Subject	0	1
Group 2: LOAd703 Dose Level 5x10e11 VP Death	0	7
Group 2: LOAd703 Dose Level 5x10e11 VP Lost to Follow-up	0	1

Baseline Characteristics

A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=7 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=17 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Total n=24 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 10.2 • n=99 Participants	60.0 years STANDARD_DEVIATION 13.4 • n=107 Participants	61.5 years STANDARD_DEVIATION 12.6 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	9 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	8 Participants n=107 Participants	13 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants	12 Participants n=107 Participants	19 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 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
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants	14 Participants n=107 Participants	21 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment Sweden	5 participants n=99 Participants	12 participants n=107 Participants	17 participants n=206 Participants
Region of Enrollment United States	2 participants n=99 Participants	5 participants n=107 Participants	7 participants n=206 Participants
Disease stage at initial diagnosis Stage 0	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Disease stage at initial diagnosis Stage I	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Disease stage at initial diagnosis Stage II	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Disease stage at initial diagnosis Stage III	4 Participants n=99 Participants	8 Participants n=107 Participants	12 Participants n=206 Participants
Disease stage at initial diagnosis Stage IV	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Disease stage at initial diagnosis Unknown	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Disease stage at study entry Stage III	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Disease stage at study entry Stage IV	7 Participants n=99 Participants	17 Participants n=107 Participants	24 Participants n=206 Participants
Disease stage at study entry Unknown	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 57 weeks post treatment initiation

The AE reporting period begins upon receiving the first LOAd703 and/or atezolizumab treatment and continues until final visit at week 57

Outcome measures

Outcome measures
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=7 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=17 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding
Tolerability Evaluated by NCI CTCAE v5.0 All Serious Adverse Events (SAEs)	6 Number of Events	11 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 Serious Adverse Reactions (SARs) Related to LOAd703	0 Number of Events	2 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Leading to Withdrawal from the Study	0 Number of Events	0 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Leading to LOAd703 Discontinuation	4 Number of Events	4 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Leading to Atezolizumab Discontinuation	6 Number of Events	4 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Leading to Death	1 Number of Events	0 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to Atezolizumab	20 Number of Events	41 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to LOAd703 and/or Atezolizumab	30 Number of Events	72 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Not Related to LOAd703 or Atezolizumab - Grade 1	7 Number of Events	32 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Not Related to LOAd703 or Atezolizumab - Grade 2	7 Number of Events	13 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Not Related to LOAd703 or Atezolizumab - Grade 3	7 Number of Events	11 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Not Related to LOAd703 or Atezolizumab - Grade 4	0 Number of Events	2 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Not Related to LOAd703 or Atezolizumab - Grade 5	1 Number of Events	0 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 All Adverse Events (AEs)	52 Number of Events	130 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 Serious Adverse Reactions (SARs) Related to Atezolizumab	0 Number of Events	1 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to LOAd703	28 Number of Events	64 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to LOAd703 - Grade 1	17 Number of Events	40 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to LOAd703 - Grade 2	11 Number of Events	22 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to LOAd703 - Grade 3	0 Number of Events	2 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to LOAd703 - Grade 4	0 Number of Events	0 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to LOAd703 - Grade 5	0 Number of Events	0 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to Atezolizumab - Grade 1	10 Number of Events	26 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to Atezolizumab - Grade 2	10 Number of Events	14 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to Atezolizumab - Grade 3	0 Number of Events	1 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to Atezolizumab - Grade 4	0 Number of Events	0 Number of Events	—	—	—	—
Tolerability Evaluated by NCI CTCAE v5.0 AEs Related to Atezolizumab - Grade 5	0 Number of Events	0 Number of Events	—	—	—	—

SECONDARY outcome

Timeframe: Up to 57 weeks post treatment initiation

Population: ORR was evaluated in participants receiving at least 3 doses of LOAd703 and/or atezolizumab with available tumor assessment data. Group 1 (1x10e11 VP): from a total of 7 participants, 6 met the criteria to be included in this analysis Group 2 (5x10e11 VP): from a total of 17 participants, 15 met the criteria to be included in this analysis

Tumor size evaluations accordingly to RECIST 1.1.Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD), Neither PR nor progressive disease, Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions. Overall Response (OR) = number of participants with CR or PR.

Outcome measures

Outcome measures
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=6 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=15 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding
Overall Response Rate	16.7 Percentage of Participants Interval 0.4 to 64.1	20.0 Percentage of Participants Interval 4.3 to 48.1	—	—	—	—

SECONDARY outcome

Timeframe: From treatment initiation until last patient last visit, assessed up till 36 months

Population: OS was evaluated in participants receiving at least 3 doses of LOAd703 and/or atezolizumab with available tumor assessment data. Group 1 (1x10e11 VP): from a total of 7 participants, 6 met the criteria to be included in this analysis Group 2 (5x10e11 VP): from a total of 17 participants, 15 met the criteria to be included in this analysis

Survival status of patients. Overall survival is defined as the time from the first dose of study treatment (LOAd703 and/or atezolizumab) until death.

Outcome measures

Outcome measures
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=6 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=15 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding
Overall Survival	26.05 Months Interval 2.1 to The maximum CI was not estimated (insufficient number of participants with events).	NA Months Interval 3.55 to Median OS, maximum CI was not reached (insufficient number of participants with events).	—	—	—	—

SECONDARY outcome

Timeframe: Up to 57 weeks post treatment initiation

Fold change between baseline and evaluation visit for anti-adenovirus antibodies (LOAd703). The baseline is the last available measurement taken before the first LOAd703 treatment. Evaluation is a measurement taken from subjects receiving at least 3 LOAd703 treatments.

Outcome measures

Outcome measures
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=5 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=12 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding
Antibodies Against LOAd703	9.05 fold change Standard Deviation 1.73	15.86 fold change Standard Deviation 9.81	—	—	—	—

SECONDARY outcome

Timeframe: Up to 57 weeks post treatment initiation

The ratio for CD8+/Treg cells analyzed in blood at baseline and evaluation visit as determined by flow cytometry. The baseline is the last available measurement taken before the first LOAd703 treatment. Evaluation is a measurement taken from subjects receiving at least 3 LOAd703 treatments.

Outcome measures

Outcome measures
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=4 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=11 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Evaluation n=4 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Evaluation n=11 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding
Immune Cell Phenotype	7.63 ratio Standard Deviation 1.42	14.86 ratio Standard Deviation 10.36	8.11 ratio Standard Deviation 1.23	25.37 ratio Standard Deviation 20.15	—	—

SECONDARY outcome

Timeframe: Up to 57 weeks post treatment initiation

Number of samples analyzed that were positive for virus particles in shedding samples.

Outcome measures

Outcome measures
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=7 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=17 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Evaluation n=7 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Evaluation n=17 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Rectal Sample n=7 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Rectal Sample n=17 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding
Virus Shedding	0 number of samples	2 number of samples	0 number of samples	1 number of samples	0 number of samples	1 number of samples

SECONDARY outcome

Timeframe: From treatment initiation until last patient last visit, assessed up till 36 months

Survival status of patients described by number of participants with event.

Outcome measures

Outcome measures
Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=7 Participants Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=17 Participants Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Evaluation Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab - Rectal Sample Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody Rectal shedding
Overall Survival (Number of Participants With Event) Number of Subjects with Event (death)	4 Number of Participants	7 Number of Participants	—	—	—	—
Overall Survival (Number of Participants With Event) Number of Subjects Censored (at the last date known to be alive)	3 Number of Participants	10 Number of Participants	—	—	—	—

Adverse Events

Group 1 LOAd703 1x10e11 VP Plus Atezolizumab

Serious events: 2 serious events

Other events: 7 other events

Deaths: 4 deaths

Group 2 LOAd703 5x10e11 VP Plus Atezolizumab

Serious events: 5 serious events

Other events: 17 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Angelica Loskog CEO

Lokon Pharma

Phone: +46 18-50 74 44

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 LOAd703 1x10e11 VP Plus Atezolizumab n=7 participants at risk Delolimogene mupadenorepvec (1x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody	Group 2 LOAd703 5x10e11 VP Plus Atezolizumab n=17 participants at risk Delolimogene mupadenorepvec (5x10e11 VP) plus atezolizumab delolimogene mupadenorepvec: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL atezolizumab: Atezolizumab is an anti-PD-L1 antibody
Vascular disorders Deep vein thrombosis	14.3% 1/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	0.00% 0/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
General disorders General physical health deterioration	14.3% 1/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	0.00% 0/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
General disorders Non-cardiac chest pain	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
General disorders Pyrexia	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Infections and infestations Abdominal abscess	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Infections and infestations Salmonellosis	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Infections and infestations Sepsis	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Vascular disorders Lymphoedema	14.3% 1/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	0.00% 0/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Cardiac disorders Cardiac failure	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Immune system disorders Cytokine release syndrome	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Injury, poisoning and procedural complications Medication error	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	5.9% 1/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.
Renal and urinary disorders Acute kidney injury	14.3% 1/7 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.	0.00% 0/17 • Adverse events were collected from the first LOAd703 and/or atezolizumab treatment up to final clinical follow-up visit at Week 57. All-Cause Mortality was assessed from treatment initiation until last patient last visit, up till 36 months. The number of participants with adverse events and not the number of events are reported.