Trial Outcomes & Findings for A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment (NCT NCT04526899)

Last Updated: 2026-01-08

Results Overview

ORR was defined as the percentage of participants in whom a complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) was observed as best overall response by blinded independent central review (BICR). Per RECIST 1.1 criteria, CR defined as the disappearance of all target lesions and PR was defined as the \>=30% decrease in the sum of the longest diameter of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

184 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2026-01-08

Participant Flow

In total,184 participants were randomized to treatment but 3 participants (2 participants in Arm 1 and 1 participant in Arm 3, respectively) did not receive the study treatment.

Participants in Arms 2 and 3 who experienced centrally verified disease progression under single agent treatment were offered addition of the other compound to the ongoing treatment after re-consent. Participants of the two add-on treatment arms are a subset of the participants in Arm 2 and Arm 3, respectively.

Participant milestones

Participant milestones
Measure	Arm 1: BNT111 + Cemiplimab Participants received BNT111 intravenous (IV) infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), along with Cemiplimab once every 3 weeks for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first.	Arm 2: BNT111 Monotherapy Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Participants in Arm 2 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received Cemiplimab once every 3 weeks as add-on treatment and BNT111 was continued according to the planned schedule. Participants received a total of 6 weekly injections during the initial trial treatment and the add-on therapy before moving to a once every 3-week schedule of injections.	Arm 3: Cemiplimab Monotherapy Participants received Cemiplimab IV infusion once every 3 weeks starting on Day 1 of Cycle 1 for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Participants in Arm 3 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received BNT111 once weekly for the first 6 weeks as add-on therapy, followed by treatments once every 3 weeks. Cemiplimab was given once every 3 weeks.
Overall Study STARTED	94	46	44
Overall Study Treated	92	46	43
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	94	46	44

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: BNT111 + Cemiplimab Participants received BNT111 intravenous (IV) infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), along with Cemiplimab once every 3 weeks for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first.	Arm 2: BNT111 Monotherapy Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Participants in Arm 2 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received Cemiplimab once every 3 weeks as add-on treatment and BNT111 was continued according to the planned schedule. Participants received a total of 6 weekly injections during the initial trial treatment and the add-on therapy before moving to a once every 3-week schedule of injections.	Arm 3: Cemiplimab Monotherapy Participants received Cemiplimab IV infusion once every 3 weeks starting on Day 1 of Cycle 1 for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Participants in Arm 3 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received BNT111 once weekly for the first 6 weeks as add-on therapy, followed by treatments once every 3 weeks. Cemiplimab was given once every 3 weeks.
Overall Study Withdrawal by Subject	3	2	2
Overall Study Lost to Follow-up	3	3	1
Overall Study Investigator's decision	1	0	0
Overall Study Death	33	17	13
Overall Study Other	1	0	0
Overall Study On-Treatment	19	10	12
Overall Study Survival Follow-up	34	14	16

Baseline Characteristics

A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: BNT111 + Cemiplimab n=94 Participants Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), along with Cemiplimab once every 3 weeks for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first.	Arm 2: BNT111 Monotherapy n=46 Participants Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks (each cycle duration=21 days), followed by once every 3 weeks for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Participants in Arm 2 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received Cemiplimab once every 3 weeks as add-on treatment and BNT111 was continued according to the planned schedule. Participants received a total of 6 weekly injections during the initial trial treatment and the add-on therapy before moving to a once every 3-week schedule of injections.	Arm 3: Cemiplimab Monotherapy n=44 Participants Participants received Cemiplimab IV infusion once every 3 weeks starting on Day 1 of Cycle 1 for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Participants in Arm 3 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received BNT111 once weekly for the first 6 weeks as add-on therapy, followed by treatments once every 3 weeks. Cemiplimab was given once every 3 weeks.	Total n=184 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 13.54 • n=18 Participants	63.1 years STANDARD_DEVIATION 13.89 • n=17 Participants	61.9 years STANDARD_DEVIATION 15.78 • n=35 Participants	62.7 years STANDARD_DEVIATION 14.12 • n=42 Participants
Sex: Female, Male Female	34 Participants n=18 Participants	17 Participants n=17 Participants	19 Participants n=35 Participants	70 Participants n=42 Participants
Sex: Female, Male Male	60 Participants n=18 Participants	29 Participants n=17 Participants	25 Participants n=35 Participants	114 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=18 Participants	2 Participants n=17 Participants	2 Participants n=35 Participants	7 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=18 Participants	41 Participants n=17 Participants	41 Participants n=35 Participants	167 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=18 Participants	3 Participants n=17 Participants	1 Participants n=35 Participants	10 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants	0 Participants n=17 Participants	00 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	89 Participants n=18 Participants	44 Participants n=17 Participants	44 Participants n=35 Participants	177 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=18 Participants	2 Participants n=17 Participants	0 Participants n=35 Participants	7 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: Analysis was performed on modified intent to treat (mITT) set that included all participants who were randomized and had at least one dose of trial treatment and had a baseline and at least one post randomization tumor response assessment. Data for this outcome measure was planned for Arm 1 only and for other arms, results will be reported in secondary outcome measures after final analysis.

Outcome measures

Outcome measures
Measure	Arm 1: BNT111 + Cemiplimab n=89 Participants Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), along with Cemiplimab once every 3 weeks for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first.
Arm 1: Objective Response Rate (ORR)	18.0 percentage of participants Interval 10.64 to 27.55

SECONDARY outcome

Timeframe: Up to 24 Months

ORR is defined as the percentage of participants in whom a CR or PR according to RECIST v1.1 observed as best overall response by BICR. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 Months

DOR is defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (progressive disease, PD) by BICR or death from any cause (whichever occurs first). Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

DCR is defined as the percentage of participants in whom a CR, PR or stable disease (SD; assessed at least 6 weeks after first dose) is observed as best overall response by BICR. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

TTR is defined as the time from randomization to the first objective tumor response (CR or PR) by BICR. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 Months

PFS is defined as the time from randomization to first objective tumor progression (PD) by BICR or death from any cause (whichever occurs first). Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

ORR is defined as the percentage of participants in whom a CR or PR according to RECIST v1.1 observed as best overall response by investigator. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 Months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

DCR defined as the percentage of participants in whom a CR, PR or stable disease (SD; assessed at least 6 weeks after first dose) is observed as best overall response by investigator. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

TTR is defined as the time from randomization to the first objective tumor response (CR or PR) as assessed by investigator. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 Months

PFS is defined as the time from randomization to first objective tumor progression (PD) by investigator or death from any cause (whichever occurs first). Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 48 months

OS is defined as the time from randomization to death from any cause. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 27 months

A treatment-emergent adverse event (TEAE) is defined as any AE with an onset date on or after the first administration of trial treatment (if the AE was absent before the first administration of trial treatment) or worsened after the first administration of trial treatment (if the AE was present before the first administration of trial treatment). Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 27 months

AEs related to the use of immune checkpoint inhibitor (ICI) therapy are defined as immune-related (IR) AEs (irAEs). Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 27 months

Participants with dose reduction and discontinuation due to TEAE will be reported. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of hematology parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of hematology parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of hematology parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of hematology parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of hematology parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of clinical chemistry parameters. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of coagulation factors. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of coagulation factors. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Blood samples will be collected for the assessment of endocrine tests. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Urine samples will be collected for the assessment of pH. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 25 months

Participants with clinically significant abnormalities in laboratory parameters will be reported. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Systolic blood pressure (in mmHg) will be assessed. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Diastolic blood pressure (in mmHg) will be assessed. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Heart rate (in beats per minute) will be assessed. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Respiratory Rate (in breaths per minute) will be assessed. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Body Temperature (in degree Celsius) will be assessed. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 25 months

Participants with clinically significant abnormalities in vital sign parameters will be reported. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Items (EORTC QLQ-C30) Global Health Status Score will be reported. Each item, except Global Health Status, is answered on a four-point scale (1-4): 1-not at all, 2-a little, 3-quite a bit, 4-very much. Response to Global Health Status is measured on a 1 to 7 scale. "1" being very poor and "7" being excellent. Positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. Raw data was linearly transformed to be in a range from 0-100 where a higher score represents good health status, while lower scores indicate poor health status. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

The EORTC QLQ-C30 questionnaire incorporates nine multi-item scales: 5 functional scales (physical, cognitive, role, emotional, and social); 3 symptom scales (pain, fatigue, and appetite loss) and a Global Health Status/QoL scale. EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening of symptoms. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline up to 25 months

The EORTC QLQ-C30 questionnaire incorporates nine multi-item scales: 5 functional scales (physical, cognitive, role, emotional, and social); 3 symptom scales (pain, fatigue, and appetite loss) and a Global Health Status/QoL scale. Each item, except Global Health Status, is answered on a four-point scale (1-4): 1-not at all, 2-a little, 3-quite a bit, 4-very much. Each scale (symptom scale \[pain, fatigue, and appetite loss\] and Global Health Status/Quality of Life \[QoL\] scale) was linearly transformed to be in range from 0-100 where a higher score represents good health status, while lower scores indicate poor health status. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 25 months

Time to first clinically meaningful deterioration in global health status score as measured by EORTC QLQ-C30 will be reported. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 25 months

Time to first clinically meaningful deterioration in symptoms and functioning as measured by EORTC QLQ-C30 will be reported. Data for this outcome measure will be reported at the time of final results posting.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: BNT111 + Cemiplimab

Serious events: 30 serious events

Other events: 89 other events

Deaths: 33 deaths

Arm 2: BNT111 Monotherapy

Serious events: 8 serious events

Other events: 43 other events

Deaths: 6 deaths

Arm 3: Cemiplimab Monotherapy

Serious events: 11 serious events

Other events: 33 other events

Deaths: 6 deaths

Add-on Treatment: BNT111 + Cemiplimab (add-on)

Serious events: 6 serious events

Other events: 22 other events

Deaths: 11 deaths

Add-on Treatment: Cemiplimab + BNT111 (add-on)

Serious events: 7 serious events

Other events: 22 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: BNT111 + Cemiplimab n=92 participants at risk Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), along with Cemiplimab once every 3 weeks for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first.	Arm 2: BNT111 Monotherapy n=46 participants at risk Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Safety data included in this reporting group is until start of the add-on treatment.	Arm 3: Cemiplimab Monotherapy n=43 participants at risk Participants received Cemiplimab IV infusion once every 3 weeks starting on Day 1 of Cycle 1 for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Safety data included in this reporting group is until start of the add-on treatment.	Add-on Treatment: BNT111 + Cemiplimab (add-on) n=25 participants at risk Participants in Arm 2 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received Cemiplimab once every 3 weeks as add-on treatment and BNT111 was continued according to the planned schedule. Participants received a total of 6 weekly injections during the initial trial treatment and the add-on therapy before moving to a once every 3-week schedule of injections. Participants included are a subset of Arm 2. Safety data included in this reporting group is from start of the add-on treatment until end of data collection.	Add-on Treatment: Cemiplimab + BNT111 (add-on) n=22 participants at risk Participants in Arm 3 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received BNT111 once weekly for the first 6 weeks as add-on therapy, followed by treatments once every 3 weeks. Cemiplimab was given once every 3 weeks. Participants included are a subset of Arm 3. Safety data included in this reporting group is from start of the add-on treatment until end of data collection.
Blood and lymphatic system disorders Anaemia	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Blood and lymphatic system disorders Anaemia of malignant disease	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Cardiac disorders Angina unstable	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Endocrine disorders Adrenocortical insufficiency acute	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Endocrine disorders Immune-mediated adrenal insufficiency	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Eye disorders Amaurosis fugax	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Constipation	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Gastritis	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Ileus	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Subileus	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Chills	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Death	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Disease progression	8.7% 8/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Drug withdrawal syndrome	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders General physical health deterioration	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Influenza like illness	2.2% 2/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Pyrexia	3.3% 3/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Hepatobiliary disorders Cholecystitis acute	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Hepatobiliary disorders Immune-mediated hepatitis	2.2% 2/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Hepatobiliary disorders Jaundice	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Immune system disorders Cytokine release syndrome	5.4% 5/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Abdominal infection	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Abscess limb	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Bronchitis	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations COVID-19	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Erysipelas	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Peritonitis	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Pneumonia	3.3% 3/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Pneumonia bacterial	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Sepsis	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Skin infection	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Subcutaneous abscess	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Urosepsis	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Viral infection	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Injury, poisoning and procedural complications Bursa injury	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Injury, poisoning and procedural complications Fall	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Injury, poisoning and procedural complications Hip fracture	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Injury, poisoning and procedural complications Infusion related reaction	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations C-reactive protein increased	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Troponin increased	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Nervous system disorders Epilepsy	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Nervous system disorders Syncope	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Nervous system disorders Transient ischaemic attack	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Vascular disorders Hypertension	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Vascular disorders Hypotension	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.

Other adverse events

Other adverse events
Measure	Arm 1: BNT111 + Cemiplimab n=92 participants at risk Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), along with Cemiplimab once every 3 weeks for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first.	Arm 2: BNT111 Monotherapy n=46 participants at risk Participants received BNT111 IV infusion once-weekly starting on Day 1 of Cycle 1 for the first 6 weeks, followed by once every 3 weeks (each cycle duration=21 days), for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Safety data included in this reporting group is until start of the add-on treatment.	Arm 3: Cemiplimab Monotherapy n=43 participants at risk Participants received Cemiplimab IV infusion once every 3 weeks starting on Day 1 of Cycle 1 for up to 24 months or until confirmed progression of disease, withdrawal of consent or unacceptable toxicity, whichever occurs first. Safety data included in this reporting group is until start of the add-on treatment.	Add-on Treatment: BNT111 + Cemiplimab (add-on) n=25 participants at risk Participants in Arm 2 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received Cemiplimab once every 3 weeks as add-on treatment and BNT111 was continued according to the planned schedule. Participants received a total of 6 weekly injections during the initial trial treatment and the add-on therapy before moving to a once every 3-week schedule of injections. Participants included are a subset of Arm 2. Safety data included in this reporting group is from start of the add-on treatment until end of data collection.	Add-on Treatment: Cemiplimab + BNT111 (add-on) n=22 participants at risk Participants in Arm 3 who experienced disease progression under monotherapy were eligible to continue with add-on therapy and received BNT111 once weekly for the first 6 weeks as add-on therapy, followed by treatments once every 3 weeks. Cemiplimab was given once every 3 weeks. Participants included are a subset of Arm 3. Safety data included in this reporting group is from start of the add-on treatment until end of data collection.
Blood and lymphatic system disorders Anaemia	12.0% 11/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.7% 4/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	11.6% 5/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	18.2% 4/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Cardiac disorders Sinus tachycardia	5.4% 5/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Abdominal pain	5.4% 5/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Abdominal pain upper	7.6% 7/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Constipation	9.8% 9/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.3% 4/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	16.0% 4/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Diarrhoea	7.6% 7/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	15.2% 7/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.3% 4/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Dysphagia	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Nausea	37.0% 34/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	23.9% 11/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	14.0% 6/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	22.7% 5/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Gastrointestinal disorders Vomiting	25.0% 23/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	13.0% 6/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	11.6% 5/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	18.2% 4/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Asthenia	14.1% 13/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	15.2% 7/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	14.0% 6/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	32.0% 8/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	31.8% 7/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Axillary pain	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Chills	48.9% 45/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	52.2% 24/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	20.0% 5/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	63.6% 14/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Fatigue	23.9% 22/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	15.2% 7/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	20.0% 5/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Influenza like illness	21.7% 20/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	21.7% 10/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Pyrexia	71.7% 66/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	76.1% 35/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	48.0% 12/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	77.3% 17/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
General disorders Temperature regulation disorder	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Immune system disorders Cytokine release syndrome	5.4% 5/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations COVID-19	5.4% 5/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.7% 4/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.3% 4/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Infections and infestations Oral herpes	3.3% 3/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.7% 4/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Alanine aminotransferase increased	5.4% 5/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Amylase increased	2.2% 2/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Aspartate aminotransferase increased	6.5% 6/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.7% 4/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Blood alkaline phosphatase increased	5.4% 5/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Blood chloride increased	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Blood creatine phosphokinase increased	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Blood lactate dehydrogenase increased	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.3% 4/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	13.6% 3/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Blood magnesium decreased	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Blood phosphorus increased	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Blood thyroid stimulating hormone increased	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	13.6% 3/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations C-reactive protein increased	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	14.0% 6/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	18.2% 4/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Gamma-glutamyltransferase increased	2.2% 2/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Lipase increased	8.7% 8/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Neutrophil count increased	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.3% 4/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Platelet count increased	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Transaminases increased	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Investigations Weight decreased	7.6% 7/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Metabolism and nutrition disorders Decreased appetite	4.3% 4/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	10.9% 5/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.3% 4/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 7/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	17.4% 8/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	13.6% 3/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Musculoskeletal and connective tissue disorders Back pain	9.8% 9/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Musculoskeletal and connective tissue disorders Myalgia	7.6% 7/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 4/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	13.0% 6/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Nervous system disorders Dizziness	6.5% 6/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	6.5% 3/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Nervous system disorders Dysgeusia	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Nervous system disorders Headache	12.0% 11/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	13.0% 6/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Psychiatric disorders Insomnia	4.3% 4/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.3% 4/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Cough	7.6% 7/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	10.9% 5/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	11.6% 5/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	9.1% 2/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.3% 3/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	18.2% 4/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.1% 1/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Skin and subcutaneous tissue disorders Erythema	3.3% 3/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.7% 2/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.0% 2/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Skin and subcutaneous tissue disorders Pruritus	12.0% 11/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.3% 2/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Skin and subcutaneous tissue disorders Rash	9.8% 9/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.2% 1/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.0% 1/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	4.5% 1/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Vascular disorders Hypertension	8.7% 8/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	8.7% 4/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	7.0% 3/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	12.0% 3/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.
Vascular disorders Hypotension	9.8% 9/92 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	17.4% 8/46 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	2.3% 1/43 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	0.00% 0/25 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.	27.3% 6/22 • From Baseline until last dose of study treatment (up to 25 months). As per protocol, non-serious adverse events (AEs) with an onset date more than 90 days after last administration of study treatment are only reported below if assessed as related to investigational medicinal product by investigator. All-cause mortality analysis was performed on all randomized participants. One participant in Arm 3 died before treatment was started. As per protocol, analysis of serious AEs and other AEs was performed on the safety set, i.e., all participants who received study treatment (i.e., at least one dose of BNT111 or cemiplimab). Events that occurred in participants after add-on treatment was started, are presented in respective add-on treatment arms to avoid duplication of data.

Additional Information

BioNTech clinical trials patient information

BioNTech SE

Phone: +49 6131 9084

Email: [email protected]

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. The sponsor will comply with the requirements for publication of trial results.
Publication restrictions are in place

Restriction type: OTHER