Trial Outcomes & Findings for Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) (NCT NCT05226598)

Last Updated: 2025-11-13

Results Overview

OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

739 participants

Primary outcome timeframe

Up to approximately 29 months

Results posted on

2025-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	MK-7684A + Chemotherapy Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Pembrolizumab + Chemotherapy Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Overall Study STARTED	366	373
Overall Study Treated	360	368
Overall Study Transitioned to Pembrolizumab + Chemotherapy	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	366	373

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-7684A + Chemotherapy Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Pembrolizumab + Chemotherapy Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Overall Study Death	186	191
Overall Study Withdrawal by Subject	6	6
Overall Study Ongoing	174	176

Baseline Characteristics

Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-7684A + Chemotherapy n=366 Participants Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Pembrolizumab + Chemotherapy n=373 Participants Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Total n=739 Participants Total of all reporting groups
Age, Continuous	64.3 Years STANDARD_DEVIATION 8.3 • n=10 Participants	64.3 Years STANDARD_DEVIATION 8.9 • n=10 Participants	64.3 Years STANDARD_DEVIATION 8.6 • n=20 Participants
Sex: Female, Male Female	98 Participants n=10 Participants	121 Participants n=10 Participants	219 Participants n=20 Participants
Sex: Female, Male Male	268 Participants n=10 Participants	252 Participants n=10 Participants	520 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	98 Participants n=10 Participants	92 Participants n=10 Participants	190 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	231 Participants n=10 Participants	249 Participants n=10 Participants	480 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	37 Participants n=10 Participants	32 Participants n=10 Participants	69 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	28 Participants n=10 Participants	22 Participants n=10 Participants	50 Participants n=20 Participants
Race (NIH/OMB) Asian	125 Participants n=10 Participants	131 Participants n=10 Participants	256 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	9 Participants n=10 Participants	5 Participants n=10 Participants	14 Participants n=20 Participants
Race (NIH/OMB) White	196 Participants n=10 Participants	210 Participants n=10 Participants	406 Participants n=20 Participants
Race (NIH/OMB) More than one race	8 Participants n=10 Participants	5 Participants n=10 Participants	13 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population includes all randomized participants with PD-L1 TPS≥1%. Participants were analyzed in the treatment group to which they were randomized.

Outcome measures

Outcome measures
Measure	MK-7684A + Chemotherapy n=240 Participants Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Pembrolizumab + Chemotherapy n=213 Participants Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%	19.4 Months Interval 17.2 to 23.9	23.5 Months Interval 19.6 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all randomized participants. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	MK-7684A + Chemotherapy n=366 Participants Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Pembrolizumab + Chemotherapy n=373 Participants Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Overall Survival (OS) in All Participants	20.0 Months Interval 17.0 to 22.5	19.7 Months Interval 17.5 to 23.4

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned PFS data are unavailable.

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) was planned to be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by blinded independent central review (BICR) was planned to be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR was planned to be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Up to approximately 29 months

Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 was planned to be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Up to approximately 29 months

Change from baseline in the score of EORTC QLQ-C30 Items 1-5 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to approximately 29 months

Change from baseline in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Up to approximately 29 months

Change from baseline in the score of EORTC QLQ-C30 Item 8 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Up to approximately 29 months

Change from baseline in the score of EORTC QLQ-LC13 Item 31 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Up to approximately 29 months

Change from baseline in the score of EORTC QLQ-LC13 Item 40 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

TTD in the score of EORTC QLQ-C30 Items 29 and 30 was planned to be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

TTD in the score of EORTC QLQ-C30 Items 1-5 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

TTD in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

TTD in the score of EORTC QLQ-C30 Item 8 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

TTD in the score of EORTC QLQ-LC13 Item 31 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

TTD in the score of EORTC QLQ-LC13 Item 40 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 46 months

The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 46 months

The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome data not reported

Adverse Events

MK-7684A + Chemotherapy

Serious events: 205 serious events

Other events: 349 other events

Deaths: 190 deaths

Pembrolizumab + Chemotherapy

Serious events: 180 serious events

Other events: 352 other events

Deaths: 193 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, 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.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	MK-7684A + Chemotherapy n=360 participants at risk Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Pembrolizumab + Chemotherapy n=368 participants at risk Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Blood and lymphatic system disorders Anaemia	4.4% 16/360 • Number of events 18 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	4.1% 15/368 • Number of events 17 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Bone marrow failure	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Febrile neutropenia	2.8% 10/360 • Number of events 10 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.4% 5/368 • Number of events 7 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Leukopenia	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Neutropenia	2.2% 8/360 • Number of events 8 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.82% 3/368 • Number of events 3 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Thrombocytopenia	2.5% 9/360 • Number of events 9 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.9% 7/368 • Number of events 7 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Acute coronary syndrome	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Acute myocardial infarction	0.56% 2/360 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.54% 2/368 • Number of events 3 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Angina unstable	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Arteriosclerosis coronary artery	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Atrial fibrillation	0.56% 2/360 • Number of events 4 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.1% 4/368 • Number of events 5 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Atrial flutter	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.54% 2/368 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Atrial tachycardia	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Cardiac arrest	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.1% 4/368 • Number of events 4 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Cardiac failure	0.56% 2/360 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.54% 2/368 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Cardiac failure congestive	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Cardiac tamponade	0.56% 2/360 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Immune-mediated myocarditis	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Myocardial infarction	0.56% 2/360 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Myocarditis	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Pericardial effusion	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Pericarditis	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Supraventricular tachycardia	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Tricuspid valve incompetence	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Ventricular extrasystoles	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Addison's disease	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Adrenal insufficiency	0.56% 2/360 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Diabetes insipidus	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Hyperthyroidism	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Hypophysitis	0.83% 3/360 • Number of events 3 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Hypopituitarism	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.54% 2/368 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.56% 2/360 • Number of events 2 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Eye disorders Retinal detachment	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Eye disorders Vision blurred	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Eye disorders Vitreous haemorrhage	0.28% 1/360 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Colitis	0.83% 3/360 • Number of events 3 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Constipation	0.00% 0/360 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.27% 1/368 • Number of events 1 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.

Other adverse events
Measure	MK-7684A + Chemotherapy n=360 participants at risk Participants receive MK-7684A (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.	Pembrolizumab + Chemotherapy n=368 participants at risk Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Blood and lymphatic system disorders Anaemia	63.3% 228/360 • Number of events 392 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	62.8% 231/368 • Number of events 368 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Neutropenia	39.7% 143/360 • Number of events 303 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	34.0% 125/368 • Number of events 319 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Blood and lymphatic system disorders Thrombocytopenia	28.3% 102/360 • Number of events 173 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	27.4% 101/368 • Number of events 176 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Hyperthyroidism	6.7% 24/360 • Number of events 24 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	5.7% 21/368 • Number of events 23 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Hypothyroidism	13.9% 50/360 • Number of events 59 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	12.0% 44/368 • Number of events 53 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Constipation	25.3% 91/360 • Number of events 112 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	25.8% 95/368 • Number of events 105 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	20.8% 75/360 • Number of events 95 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	15.5% 57/368 • Number of events 89 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Nausea	33.6% 121/360 • Number of events 208 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	31.8% 117/368 • Number of events 216 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Vomiting	15.8% 57/360 • Number of events 89 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.9% 40/368 • Number of events 51 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
General disorders Asthenia	21.9% 79/360 • Number of events 109 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	21.7% 80/368 • Number of events 128 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
General disorders Chest pain	4.2% 15/360 • Number of events 20 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.9% 29/368 • Number of events 37 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
General disorders Fatigue	21.7% 78/360 • Number of events 116 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	19.3% 71/368 • Number of events 100 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
General disorders Oedema peripheral	13.1% 47/360 • Number of events 59 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	11.7% 43/368 • Number of events 52 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
General disorders Pyrexia	8.9% 32/360 • Number of events 43 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	9.2% 34/368 • Number of events 43 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations COVID-19	10.0% 36/360 • Number of events 37 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	8.2% 30/368 • Number of events 32 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Nasopharyngitis	3.6% 13/360 • Number of events 21 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	5.4% 20/368 • Number of events 27 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Pneumonia	6.7% 24/360 • Number of events 24 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.2% 23/368 • Number of events 32 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Urinary tract infection	5.8% 21/360 • Number of events 22 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	8.2% 30/368 • Number of events 41 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Alanine aminotransferase increased	25.8% 93/360 • Number of events 155 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	25.5% 94/368 • Number of events 143 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Amylase increased	16.7% 60/360 • Number of events 106 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.3% 38/368 • Number of events 64 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	24.2% 87/360 • Number of events 140 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	24.5% 90/368 • Number of events 169 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood alkaline phosphatase increased	9.7% 35/360 • Number of events 57 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.1% 37/368 • Number of events 58 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood creatinine increased	16.4% 59/360 • Number of events 103 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	14.9% 55/368 • Number of events 76 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood lactate dehydrogenase increased	10.0% 36/360 • Number of events 60 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	9.8% 36/368 • Number of events 56 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Gamma-glutamyltransferase increased	8.1% 29/360 • Number of events 37 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.6% 39/368 • Number of events 56 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Lipase increased	12.5% 45/360 • Number of events 86 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	11.4% 42/368 • Number of events 68 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Lymphocyte count decreased	14.2% 51/360 • Number of events 109 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	8.7% 32/368 • Number of events 69 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Weight decreased	17.8% 64/360 • Number of events 74 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	13.6% 50/368 • Number of events 57 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Weight increased	7.2% 26/360 • Number of events 27 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	3.5% 13/368 • Number of events 14 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations White blood cell count decreased	27.8% 100/360 • Number of events 269 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	23.9% 88/368 • Number of events 215 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	25.3% 91/360 • Number of events 132 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	20.4% 75/368 • Number of events 103 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	10.3% 37/360 • Number of events 55 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.1% 37/368 • Number of events 65 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypoalbuminaemia	13.6% 49/360 • Number of events 80 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	16.0% 59/368 • Number of events 107 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypocalcaemia	8.1% 29/360 • Number of events 40 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	5.2% 19/368 • Number of events 28 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypokalaemia	11.4% 41/360 • Number of events 57 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.3% 38/368 • Number of events 55 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypomagnesaemia	9.4% 34/360 • Number of events 53 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	8.7% 32/368 • Number of events 50 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	11.4% 41/360 • Number of events 60 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.6% 39/368 • Number of events 59 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	11.4% 41/360 • Number of events 53 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.9% 40/368 • Number of events 49 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Back pain	8.6% 31/360 • Number of events 35 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	5.4% 20/368 • Number of events 23 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 24/360 • Number of events 29 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.1% 26/368 • Number of events 44 • Up to approximately 29 months The population for all-cause mortality includes all participants. AE populations include all randomized participants who received at least 1 dose of study drug. Terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.