Trial Outcomes & Findings for A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer (NCT NCT05775289)

NCT ID: NCT05775289

Last Updated: 2026-02-11

Results Overview

PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 182 participants
• Primary outcome timeframe: Randomization to date of first documented disease progression or death (up to approximately 15 months)
• Results posted on: 2026-02-11

Participant Flow

Male and female participants ages at least 18 years with previously untreated locally advanced or metastatic non-small cell lung cancer.

Participant milestones

Measure	Pembro + Chemotherapy (Squamous) Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy (Non-squamous) Participants with non-squamous (NSQ) NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Squamous) Participants with SQ NSCLC received blinded tobemstomig in combination with paclitaxel and carboplatin on Day 1 Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Non-squamous) Participants with NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Overall Study STARTED	25	66	24	67
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	25	66	24	67

Reasons for withdrawal

Measure	Pembro + Chemotherapy (Squamous) Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy (Non-squamous) Participants with non-squamous (NSQ) NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Squamous) Participants with SQ NSCLC received blinded tobemstomig in combination with paclitaxel and carboplatin on Day 1 Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Non-squamous) Participants with NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Overall Study Study Ongoing	20	53	15	55
Overall Study Death	4	11	8	12
Overall Study Lost to Follow-up	0	1	0	0
Overall Study Progressive Disease	0	0	1	0
Overall Study Withdrawal by Subject	1	1	0	0

Baseline Characteristics

A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Pembro + Chemotherapy (Squamous) n=25 Participants Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy (Non-squamous) n=66 Participants Participants with non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Squamous) n=24 Participants Participants with SQ NSCLC received blinded tobemstomig in combination with paclitaxel and carboplatin on Day 1 Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Non-squamous) n=67 Participants Participants with NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Total n=182 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	5 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	5 Participants n=33 Participants
Race (NIH/OMB) White	18 Participants n=4 Participants	40 Participants n=4 Participants	19 Participants n=8 Participants	53 Participants n=32 Participants	130 Participants n=33 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	2 Participants n=32 Participants	2 Participants n=33 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=4 Participants	10 Participants n=4 Participants	1 Participants n=8 Participants	7 Participants n=32 Participants	20 Participants n=33 Participants
Age, Continuous	66.2 Years STANDARD_DEVIATION 6.8 • n=4 Participants	63.2 Years STANDARD_DEVIATION 9.6 • n=4 Participants	63.0 Years STANDARD_DEVIATION 11.2 • n=8 Participants	64.8 Years STANDARD_DEVIATION 8.3 • n=32 Participants	64.2 Years STANDARD_DEVIATION 9.0 • n=33 Participants
Sex: Female, Male Female	5 Participants n=4 Participants	27 Participants n=4 Participants	8 Participants n=8 Participants	24 Participants n=32 Participants	64 Participants n=33 Participants
Sex: Female, Male Male	20 Participants n=4 Participants	39 Participants n=4 Participants	16 Participants n=8 Participants	43 Participants n=32 Participants	118 Participants n=33 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=4 Participants	10 Participants n=4 Participants	5 Participants n=8 Participants	7 Participants n=32 Participants	29 Participants n=33 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=4 Participants	49 Participants n=4 Participants	17 Participants n=8 Participants	53 Participants n=32 Participants	137 Participants n=33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	7 Participants n=4 Participants	2 Participants n=8 Participants	7 Participants n=32 Participants	16 Participants n=33 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants	0 Participants n=32 Participants	3 Participants n=33 Participants
Race (NIH/OMB) Asian	4 Participants n=4 Participants	10 Participants n=4 Participants	3 Participants n=8 Participants	5 Participants n=32 Participants	22 Participants n=33 Participants

PRIMARY outcome

Timeframe: Randomization to date of first documented disease progression or death (up to approximately 15 months)

Population: The analysis population included all participants that were randomized.

PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Progression-Free Survival (PFS)	7.62 Months Interval 5.62 to Value is NA due to insufficient number of participants with the event.	7.13 Months Interval 5.59 to Value is NA due to insufficient number of participants with the event.

PRIMARY outcome

Timeframe: Up to approximately 15 months

Population: The analysis population was all randomized participants with measurable disease at baseline.

ORR is defined as the percentage of participants who experience a complete reponse or partial response on two consecutive occasions at least 4 weeks apart as determined by the investigator according to RECIST v1.1.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Objective Response Rate (ORR)	41.1 Percent of participants Interval 31.51 to 51.44	46.2 Percent of participants Interval 36.28 to 56.34

SECONDARY outcome

Timeframe: From randomization to death from any cause (up to approximately 15 months)

Population: The efficacy analysis population consisted of all participants.

OS is defined as the time from randomization to death from any cause.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Overall Survival (OS)	13.17 Months Interval 12.02 to Value is NA due to insufficient number of participants with the event.	NA Months Interval 13.37 to Value is NA due to insufficient number of participants with the event.

SECONDARY outcome

Timeframe: From the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (up to approximately 15 months)

Population: The DOR analysis population consisted of participants who achieved an objective response to study treatment.

DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first.

Outcome measures

Measure	Tobe + Chemotherapy n=37 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=42 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Duration of Response (DOR)	NA Months Value is NA due to insufficient number of participants with the event.	NA Months Interval 9.7 to Value is NA due to insufficient number of participants with the event.

SECONDARY outcome

Timeframe: Up to 28 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC Item Library 17 (IL17) physical functioning scale measures a participant's ability to perform a variety of physical activities. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate better outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning Baseline	80.00 Scores on a scale Interval 0.0 to 100.0	86.67 Scores on a scale Interval 6.7 to 100.0
Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning Cycle 1 Day 1	93.3 Scores on a scale Interval 93.3 to 93.3	—
Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning Cycle 2 Day 1	80.00 Scores on a scale Interval 0.0 to 100.0	80.00 Scores on a scale Interval 20.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning Cycle 3 Day 1	80.00 Scores on a scale Interval 20.0 to 100.0	80.00 Scores on a scale Interval 20.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the European Organisation for Research and Treatment (EORTC): Physical Functioning Cycle 4 Day 1	80.00 Scores on a scale Interval 6.7 to 100.0	86.67 Scores on a scale Interval 6.7 to 100.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC Item Library 17 (IL17) Global Health Status/Quality of Life (GHS/QoL) scale measures the participant's overall health and quality of health over the last week. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate a higher quality of life.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Global Health Status/Quality of Life (GHS/QoL) Baseline	66.67 Scores on a scale Interval 0.0 to 100.0	66.67 Scores on a scale Interval 0.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Global Health Status/Quality of Life (GHS/QoL) Cycle 1 Day 1	83.3 Scores on a scale Interval 83.3 to 83.3	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Global Health Status/Quality of Life (GHS/QoL) Cycle 2 Day 1	66.67 Scores on a scale Interval 16.7 to 100.0	66.67 Scores on a scale Interval 0.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Global Health Status/Quality of Life (GHS/QoL) Cycle 3 Day 1	66.67 Scores on a scale Interval 0.0 to 100.0	66.67 Scores on a scale Interval 0.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Global Health Status/Quality of Life (GHS/QoL) Cycle 4 Day 1	66.67 Scores on a scale Interval 0.0 to 100.0	66.67 Scores on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC Item Library 17 (IL17) role functioning scale measures the degree to which disease or treatment interferes with the participant's work or daily activities. Raw scores are calculated by estimating the average of the items that contribute to the scale. Linear transformation is then used to standardize the raw score to a total score range of 0-100. Higher scores for this measure indicate better outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Role Functioning Baseline	83.33 Scores on a scale Interval 0.0 to 100.0	91.67 Scores on a scale Interval 0.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Role Functioning Cycle 1 Day 1	83.3 Scores on a scale Interval 83.3 to 83.3	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Role Functioning Cycle 2 Day 1	83.33 Scores on a scale Interval 0.0 to 100.0	83.33 Scores on a scale Interval 0.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Role Functioning Cycle 3 Day 1	83.33 Scores on a scale Interval 0.0 to 100.0	66.67 Scores on a scale Interval 0.0 to 100.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Role Functioning Cycle 4 Day 1	83.33 Scores on a scale Interval 0.0 to 100.0	83.33 Scores on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 85 lung cancer symptoms/how much did you cough measure assesses the severity and frequency of coughing over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Lung Cancer Symptoms/How Much Did You Cough Baseline	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Lung Cancer Symptoms/How Much Did You Cough Cycle 1 Day 1	1.00 Scores on a scale Interval 1.0 to 1.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Lung Cancer Symptoms/How Much Did You Cough Cycle 2 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Lung Cancer Symptoms/How Much Did You Cough Cycle 3 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Lung Cancer Symptoms/How Much Did You Cough Cycle 4 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 85 short of breath when rested measure assesses the degree of difficulty breathing while resting over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Rested Cycle 2 Day 1	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 3.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Rested Baseline	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Rested Cycle 1 Day 1	1.00 Scores on a scale Interval 1.0 to 1.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Rested Cycle 3 Day 1	1.00 Scores on a scale Interval 1.0 to 3.0	1.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Rested Cycle 4 Day 1	1.00 Scores on a scale Interval 1.0 to 2.0	1.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 85 short of breath when walked measure assesses the degree of difficulty breathing while walking over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Walked Cycle 3 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Walked Cycle 4 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Walked Baseline	2.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Walked Cycle 1 Day 1	1.00 Scores on a scale Interval 1.0 to 1.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath When Walked Cycle 2 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 85 short of breath climbed stairs measure assesses the degree of difficulty breathing while climbing stairs over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath Climbed Stairs Cycle 2 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath Climbed Stairs Cycle 3 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath Climbed Stairs Baseline	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath Climbed Stairs Cycle 1 Day 1	2.00 Scores on a scale Interval 2.0 to 2.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Short of Breath Climbed Stairs Cycle 4 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 85 pain in chest measure assesses the severity of chest pain over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Pain in Chest Cycle 4 Day 1	1.00 Scores on a scale Interval 1.0 to 3.0	1.00 Scores on a scale Interval 1.0 to 3.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Pain in Chest Baseline	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 3.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Pain in Chest Cycle 1 Day 1	1.00 Scores on a scale Interval 1.0 to 1.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Pain in Chest Cycle 2 Day 1	1.00 Scores on a scale Interval 1.0 to 3.0	1.00 Scores on a scale Interval 1.0 to 3.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Pain in Chest Cycle 3 Day 1	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 132 need to rest measure assesses how often the participant felt the need to rest over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Need to Rest Baseline	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Need to Rest Cycle 1 Day 1	2.00 Scores on a scale Interval 2.0 to 2.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Need to Rest Cycle 2 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Need to Rest Cycle 3 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Need to Rest Cycle 4 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 132 felt weak measure assesses how often the participant felt weak over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Felt Weak Baseline	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Felt Weak Cycle 1 Day 1	2.00 Scores on a scale Interval 2.0 to 2.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Felt Weak Cycle 2 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Felt Weak Cycle 3 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Felt Weak Cycle 4 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 132 tired measure assesses how often the participant felt tired over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Tired Baseline	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Tired Cycle 1 Day 1	2.00 Scores on a scale Interval 2.0 to 2.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Tired Cycle 2 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Tired Cycle 3 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Tired Cycle 4 Day 1	2.00 Scores on a scale Interval 1.0 to 4.0	2.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The analysis population for patient-reported outcomes (PROs) includes all randomized participants. Baseline PRO measurements were taken prior to Cycle 1 Day 1, resulting in few or no data points for that timepoint.

The EORTC IL 188 aches/pain in bones measure assessesthe severity of bone pain over the past week. The single item is scored on a scale of 1-4, with higher scores indicating worse outcomes.

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Change in Participant-reported Outcomes as Assessed by the EORTC: Aches/Pain in Bones Baseline	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Aches/Pain in Bones Cycle 1 Day 1	1.00 Scores on a scale Interval 1.0 to 1.0	—
Change in Participant-reported Outcomes as Assessed by the EORTC: Aches/Pain in Bones Cycle 2 Day 1	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Aches/Pain in Bones Cycle 3 Day 1	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 4.0
Change in Participant-reported Outcomes as Assessed by the EORTC: Aches/Pain in Bones Cycle 4 Day 1	1.00 Scores on a scale Interval 1.0 to 4.0	1.00 Scores on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: From the start of treatment to 90 days after the final dose of treatment (up to 28 months)

Outcome measures

Measure	Tobe + Chemotherapy n=90 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy n=91 Participants Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Number of Participants With Adverse Events (AEs)	89 Count of participants	89 Count of participants

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Outcome measures

Measure	Tobe + Chemotherapy n=88 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Maximum Serum Concentration (Cmax) of Tobemstomig Tobe + Paclitaxel + Carboplatin	188 ug/mL Geometric Coefficient of Variation 27.3	—
Maximum Serum Concentration (Cmax) of Tobemstomig Tobe + Pemetrexed + Carboplatin	191 ug/mL Geometric Coefficient of Variation 43.1	—

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Outcome measures

Measure	Tobe + Chemotherapy n=88 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Time of Maximum Concentration (Tmax) of Tobemstomig Tobe + Paclitaxel + Carboplatin	0.0649 Day Interval 0.0208 to 9.13	—
Time of Maximum Concentration (Tmax) of Tobemstomig Tobe + Pemetrexed + Carboplatin	0.0646 Day Interval 0.0521 to 21.0	—

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Outcome measures

Measure	Tobe + Chemotherapy n=56 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Clearance (CL) of Tobemstomig Tobe + Paclitaxel + Carboplatin	246 mL/day Geometric Coefficient of Variation 55.6	—
Clearance (CL) of Tobemstomig Tobe + Pemetrexed + Carboplatin	231 mL/day Geometric Coefficient of Variation 34.5	—

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Outcome measures

Measure	Tobe + Chemotherapy n=56 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Volume of Distribution at Steady State (Vss) of Tobemstomig Tobe + Paclitaxel + Carboplatin	3.65 Liters Geometric Coefficient of Variation 40.2	—
Volume of Distribution at Steady State (Vss) of Tobemstomig Tobe + Pemetrexed + Carboplatin	3.56 Liters Geometric Coefficient of Variation 31.6	—

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Outcome measures

Measure	Tobe + Chemotherapy n=88 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Area Under the Concentration-time Curve (AUC) of Tobemstomig Tobe + Pemetrexed + Carboplatin	1500 day*ug/mL Geometric Coefficient of Variation 114.2	—
Area Under the Concentration-time Curve (AUC) of Tobemstomig Tobe + Paclitaxel + Carboplatin	1470 day*ug/mL Geometric Coefficient of Variation 31.8	—

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Outcome measures

Measure	Tobe + Chemotherapy n=56 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Half-life (T1/2) of Tobemstomig Tobe + Paclitaxel + Carboplatin	8.45 Day Geometric Coefficient of Variation 196.4	—
Half-life (T1/2) of Tobemstomig Tobe + Pemetrexed + Carboplatin	10.4 Day Geometric Coefficient of Variation 83.2	—

SECONDARY outcome

Timeframe: Baseline up to approximately 15 months

Population: The pharmacokinetic (PK) population consisted of participants who received IV tobemstomig.

Outcome measures

Measure	Tobe + Chemotherapy n=77 Participants Participants with squamous or NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy Participants with squamous or non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Percentage of Participants With Anti-drug Antibodies (ADAs) Treatment-Induced	42.9 Percentage of participants	—
Percentage of Participants With Anti-drug Antibodies (ADAs) Treatment-Emergent	42.9 Percentage of participants	—

Adverse Events

Pembro + Chemotherapy (Squamous)

Serious events: 10 serious events

Other events: 25 other events

Deaths: 4 deaths

Pembro + Chemotherapy (Non-squamous)

Serious events: 26 serious events

Other events: 63 other events

Deaths: 11 deaths

Tobe + Chemotherapy (Squamous)

Serious events: 14 serious events

Other events: 24 other events

Deaths: 8 deaths

Tobe + Chemotherapy (Non-squamous)

Serious events: 35 serious events

Other events: 63 other events

Deaths: 12 deaths

Serious adverse events

Measure	Pembro + Chemotherapy (Squamous) n=25 participants at risk Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy (Non-squamous) n=65 participants at risk Participants with non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Squamous) n=24 participants at risk Participants with SQ NSCLC received blinded tobemstomig in combination with paclitaxel and carboplatin on Day 1 Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Non-squamous) n=65 participants at risk Participants with NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Cardiac disorders Atrial flutter	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Cardiac disorders Cardiac failure	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Cardiac disorders Cardiovascular disorder	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Cardiac disorders Myocardial infarction	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Cardiac disorders Myocarditis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Endocrine disorders Adrenal insufficiency	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Bronchitis	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations COVID-19	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Psychiatric disorders Delirium	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Vascular disorders Embolism arterial	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Vascular disorders Hypotension	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Vascular disorders Orthostatic hypotension	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Anaemia	4.0% 1/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Neutropenia	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Pancytopenia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Cardiac disorders Angina pectoris	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Colitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Duodenal ulcer	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Nausea	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Stomatitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Asthenia	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Death	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Pain	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Pyrexia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Bacterial infection	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations COVID-19 pneumonia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Diverticulitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Infection	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Influenza	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Large intestine infection	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Lymphangitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Pneumonia	8.0% 2/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.5% 3/24 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Pneumonia bacterial	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Pneumonia influenzal	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Pulmonary sepsis	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Respiratory tract infection	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Sepsis	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Sinusitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Urinary tract infection	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Injury, poisoning and procedural complications Fall	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations C-reactive protein increased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Troponin increased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Weight decreased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations White blood cell count decreased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hypophagia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Cognitive disorder	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Syncope	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Psychiatric disorders Confusional state	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Renal and urinary disorders Acute kidney injury	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Renal and urinary disorders Nephritis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Renal and urinary disorders Urinary retention	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.0% 2/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)

Other adverse events

Measure	Pembro + Chemotherapy (Squamous) n=25 participants at risk Participants with squamous non small-cell lung cancer (NSCLC) received blinded pembrolizumab (pembro) in combination with paclitaxel and carboplatin on Day 1 every three weeks (Q3W) for four 21-day cycles, followed by blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Pembro + Chemotherapy (Non-squamous) n=65 participants at risk Participants with non-squamous NSCLC received induction treatment with blinded pembro in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by maintenance therapy with blinded pembro with pemetrexed Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Squamous) n=24 participants at risk Participants with SQ NSCLC received blinded tobemstomig in combination with paclitaxel and carboplatin on Day 1 Q3W until disease progression or treatment discontinuation for a maximum of 24 months of treatment.	Tobe + Chemotherapy (Non-squamous) n=65 participants at risk Participants with NSQ NSCLC received induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin on Day 1 Q3W for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig with pemetrexed until disease progression or treatment discontinuation for a maximum of 24 months of treatment.
Infections and infestations Upper respiratory tract infection	12.0% 3/25 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Diarrhoea	16.0% 4/25 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	24.6% 16/65 • Number of events 19 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	29.2% 7/24 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	24.6% 16/65 • Number of events 22 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Dyspepsia	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Nausea	16.0% 4/25 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	36.9% 24/65 • Number of events 37 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	29.2% 7/24 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	49.2% 32/65 • Number of events 43 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Stomatitis	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Vomiting	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	10.8% 7/65 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	16.9% 11/65 • Number of events 15 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Asthenia	20.0% 5/25 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	30.8% 20/65 • Number of events 31 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	29.2% 7/24 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	32.3% 21/65 • Number of events 42 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Chest pain	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Fatigue	16.0% 4/25 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	21.5% 14/65 • Number of events 17 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	21.5% 14/65 • Number of events 16 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Mucosal inflammation	12.0% 3/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Oedema peripheral	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Pain	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
General disorders Pyrexia	16.0% 4/25 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Conjunctivitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Nasopharyngitis	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.5% 3/24 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Oral candidiasis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Pneumonia	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Rhinitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Psychiatric disorders Anxiety	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Psychiatric disorders Insomnia	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Renal and urinary disorders Acute kidney injury	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Skin and subcutaneous tissue disorders Rash	28.0% 7/25 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	16.9% 11/65 • Number of events 13 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	18.5% 12/65 • Number of events 16 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Constipation	20.0% 5/25 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	27.7% 18/65 • Number of events 23 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	33.8% 22/65 • Number of events 25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Thrombocytopenia	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.3% 8/65 • Number of events 13 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Cardiac disorders Atrial fibrillation	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Endocrine disorders Hyperthyroidism	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	13.8% 9/65 • Number of events 10 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Endocrine disorders Hypothyroidism	12.0% 3/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.5% 3/24 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	10.8% 7/65 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Eye disorders Lacrimation increased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	15.4% 10/65 • Number of events 12 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	10.8% 7/65 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Abdominal distension	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Gastrointestinal disorders Abdominal pain upper	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Neutropenia	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	24.6% 16/65 • Number of events 22 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	16.7% 4/24 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	29.2% 19/65 • Number of events 32 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Anaemia	44.0% 11/25 • Number of events 13 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	61.5% 40/65 • Number of events 52 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	25.0% 6/24 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	53.8% 35/65 • Number of events 48 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Infections and infestations Urinary tract infection	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Injury, poisoning and procedural complications Infusion related reaction	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	25.0% 6/24 • Number of events 10 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Alanine aminotransferase increased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 10 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.0% 13/65 • Number of events 20 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Aspartate aminotransferase increased	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 10 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.5% 3/24 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	15.4% 10/65 • Number of events 14 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Blood bicarbonate decreased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Blood creatinine increased	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	13.8% 9/65 • Number of events 12 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Blood lactate dehydrogenase increased	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Gamma-glutamyltransferase increased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Lymphocyte count decreased	4.0% 1/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.5% 3/24 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Neutrophil count decreased	4.0% 1/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 11 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Platelet count decreased	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 10 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.3% 8/65 • Number of events 13 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations Weight decreased	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Investigations White blood cell count decreased	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.5% 3/24 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Decreased appetite	28.0% 7/25 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	23.1% 15/65 • Number of events 22 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	26.2% 17/65 • Number of events 18 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hyperglycaemia	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	10.8% 7/65 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hypokalaemia	8.0% 2/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	16.7% 4/24 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Metabolism and nutrition disorders Hypomagnesaemia	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	10.8% 7/65 • Number of events 10 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	9.2% 6/65 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 5/25 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	10.8% 7/65 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	12.3% 8/65 • Number of events 9 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Musculoskeletal and connective tissue disorders Back pain	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Musculoskeletal and connective tissue disorders Bone pain	8.0% 2/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Musculoskeletal and connective tissue disorders Pain in extremity	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Dysgeusia	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Headache	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Neuropathy peripheral	32.0% 8/25 • Number of events 8 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	29.2% 7/24 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Neurotoxicity	12.0% 3/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Paraesthesia	20.0% 5/25 • Number of events 6 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Nervous system disorders Peripheral sensory neuropathy	8.0% 2/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Cough	16.0% 4/25 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	16.9% 11/65 • Number of events 14 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.0% 3/25 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	15.4% 10/65 • Number of events 10 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	16.7% 4/24 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	13.8% 9/65 • Number of events 11 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	1.5% 1/65 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.0% 2/25 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.2% 1/24 • Number of events 1 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	3.1% 2/65 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Skin and subcutaneous tissue disorders Alopecia	20.0% 5/25 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	6.2% 4/65 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	16.7% 4/24 • Number of events 4 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	4.6% 3/65 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/25 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	8.3% 2/24 • Number of events 2 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Skin and subcutaneous tissue disorders Pruritus	20.0% 5/25 • Number of events 7 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	13.8% 9/65 • Number of events 11 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	20.8% 5/24 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	7.7% 5/65 • Number of events 5 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)
Skin and subcutaneous tissue disorders Skin exfoliation	8.0% 2/25 • Number of events 3 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/24 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)	0.00% 0/65 • From the start of treatment to 90 days after the final dose of treatment (up to 28 months)

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER