Trial Outcomes & Findings for Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002) (NCT NCT02609984)

NCT ID: NCT02609984

Last Updated: 2020-07-07

Results Overview

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 modified to use immune-related response criteria (irRC) confirmation and unidimensional tumor measurements as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in tumor burden compared with nadir (at any single time point) in 2 consecutive observations ≥4 weeks apart. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 89 participants
• Primary outcome timeframe: Up to approximately 36.1 months
• Results posted on: 2020-07-07

Participant Flow

Participant milestones

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by intravenous (IV) infusion every 3 weeks (Q3W) for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered intradermally (ID) on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered intramuscularly (IM) and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of New York Esophageal Squamous Cell Carcinoma 1 (NY ESO-1) protein.	Atezolizumab Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Overall Study STARTED	45	44
Overall Study Treated	45	43
Overall Study COMPLETED	1	5
Overall Study NOT COMPLETED	44	39

Reasons for withdrawal

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by intravenous (IV) infusion every 3 weeks (Q3W) for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered intradermally (ID) on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered intramuscularly (IM) and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of New York Esophageal Squamous Cell Carcinoma 1 (NY ESO-1) protein.	Atezolizumab Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Overall Study Death	29	26
Overall Study Participation Discontinued by Sponsor	12	10
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	0	1
Overall Study Disease Progression	2	0

Baseline Characteristics

Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)

Baseline characteristics by cohort

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=44 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.	Total n=89 Participants Total of all reporting groups
Age, Continuous	46.2 Years STANDARD_DEVIATION 16.52 • n=5 Participants	46.7 Years STANDARD_DEVIATION 14.06 • n=7 Participants	46.4 Years STANDARD_DEVIATION 15.27 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 36.1 months

Population: The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the electronic Case Report Form (eCRF). Participants were included in the treatment group to which they were randomized.

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 modified to use immune-related response criteria (irRC) confirmation and unidimensional tumor measurements as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in tumor burden compared with nadir (at any single time point) in 2 consecutive observations ≥4 weeks apart. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=44 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Progression-Free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	2.6 Months Interval 1.4 to 2.9	1.6 Months Interval 1.5 to 2.7

PRIMARY outcome

Timeframe: Up to approximately 36.1 months

Population: The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized.

OS was determined for all participants and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last follow-up. The OS was analyzed using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=44 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Overall Survival (OS)	18.2 Months Interval 10.1 to 22.1	18.0 Months Interval 15.3 to 26.5

SECONDARY outcome

Timeframe: Up to approximately 42 days

Population: The analysis population included all participants who participated in the safety run-in period and received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab.

DLTs will be evaluated during the safety run-in period. Any treatment emergent Grade 3 or higher adverse event (AE) that occurs in the first 42 days after initiation of study treatment, that is deemed possibly, probably or definitely related to the combination of CMB305 and atezolizumab will be considered a DLT with the following exceptions:

• Alopecia or vomiting (unless not controlled by optimal anti-emetics)
• Hepatic enzyme elevations associated with the baseline Grade 2 abnormalities
• Grade 3 laboratory AEs that are asymptomatic and return to baseline or to Grade 1 within 3 days, unless identified specifically as DLT by the investigator or the Data Monitoring Committee (DMC)
• Grade 3 fatigue
• Grade 3 systemic reactions (such as fever, headache, influenza like symptoms, myalgia, malaise, or nausea) that return to baseline or Grade 1 within 3 days of study inoculation

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=6 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=6 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Number of Participants Experiencing a Dose-Limiting Toxicity (DLT)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 36.1 months

Population: The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab.

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=43 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Number of Participants Who Experienced At Least One Adverse Event (AE)	44 Participants	43 Participants

SECONDARY outcome

Timeframe: Up to approximately 24 months

Population: The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab.

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=43 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Month 3

Population: The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized.

PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first, per RECIST 1.1 modified to use irRC confirmation and unidimensional tumor measurements as assessed by BICR. PD was defined as ≥20% increase in tumor burden compared with nadir (at any single time point) in 2 consecutive observations ≥4 weeks apart. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. Participants were evaluated every 6 weeks with radiographic imaging to assess their response to treatment. The PFS rate was calculated as the percentage of participants with PFS at Month 3.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=44 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Progression-Free Survival (PFS) Rate at Month 3 Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	32.6 Percentage of participants Interval 19.4 to 46.4	23.8 Percentage of participants Interval 12.4 to 37.4

SECONDARY outcome

Timeframe: Month 6

Population: The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized.

PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first, per RECIST 1.1 modified to use irRC confirmation and unidimensional tumor measurements as assessed by BICR. PD was defined as ≥20% increase in tumor burden compared with nadir (at any single time point) in 2 consecutive observations ≥4 weeks apart. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. Participants were evaluated every 6 weeks with radiographic imaging to assess their response to treatment. The PFS rate was calculated as the percentage of participants with PFS at Month 6.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=44 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Progression-Free Survival (PFS) Rate at Month 6 Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	16.5 Percentage of participants Interval 7.0 to 29.6	9.5 Percentage of participants Interval 3.0 to 20.6

SECONDARY outcome

Timeframe: Up to approximately 36.1 months

Population: The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab.

TTNT was the time from date of randomization to the start date of subsequent treatment. Participants were treated for up to approximately 2 years and then followed until next treatment or death. Participants who did not receive subsequent treatment were censored at the date of last contact or death. The TTNT was analyzed using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=43 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Time to Next Treatment (TTNT)	6.2 Months Interval 4.4 to 9.1	4.9 Months Interval 3.3 to 6.4

SECONDARY outcome

Timeframe: Up to approximately 36.1 months

Population: The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized.

DMFS was the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants without metastasis and death were censored at the date of last contact or death. The DMFS was analyzed using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=44 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Distant Metastasis Free Survival (DMFS)	5.3 Months Interval 0.0 to 23.5	5.5 Months Interval 0.0 to 31.8

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab and had data available for baseline antibody analysis.

The number of participants with anti-NY-ESO-1 antibodies at baseline was measured using an enzyme-linked immunosorbent assay (ELISA) with recombinant NY-ESO1 protein. A titer of >1:100 was considered positive. The number of participants that were anti-NY-ESO-1 antibody positive at baseline is presented.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=35 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=29 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) Antibody at Baseline	14 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to approximately 24 months

Population: The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab and had data available for induction after treatment antibody analysis.

The number of participants with anti-NY-ESO-1 antibodies induced after treatment was measured using an enzyme-linked immunosorbent assay (ELISA) with recombinant NY-ESO1protein. A titer of >1:100 was considered positive. The induction of anti-NY-ESO-1 antibody response was defined as a ≥4-fold increase in the titer or the presence of a newly positive response after the first dose of treatment. The number of participants that were anti-NY-ESO-1 antibody positive after induction with treatment is presented.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=32 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=27 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) Antibody After Induction With Treatment	16 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab and had data available for baseline T cell analysis.

Anti-NY-ESO-1 CD4 and CD8 positive T-cell responses were measured by interferon gamma detecting enzyme-linked ImmunoSpot (ELISPOT) using isolated CD4 and CD8 positive T cells from peripheral blood mononuclear cells (PBMCs) expanded in vitro with a NY-ESO-1 peptide pool (20-mer peptides, 10-mer overlap) and considered positive if there were >50 spot-forming units/50,000 cells observed for NY-ESO-1 peptides and a ≥2-fold increase in spot-forming units compared with a negative control. The number of participants that were anti-NY-ESO-1 T cell positive at baseline is presented.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=27 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=24 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) T Cells at Baseline	17 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to approximately 24 months

Population: The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab and had data available for induction after treatment T cell analysis.

Anti-NY-ESO-1 CD4 and CD8 positive T-cell responses were measured by interferon gamma detecting enzyme-linked ImmunoSpot (ELISPOT) using isolated CD4 and CD8 positive T cells expanded with a NY-ESO-1 peptide (20-mer peptides, 10-mer overlap) and considered positive if there were >50 spot-forming units (SPU)/50,000 cells observed for NY-ESO-1 peptides and a ≥2-fold increase in SPU compared with a negative control. The induction of an anti-NYESO-1 CD4 or CD8 positive T-cell response was defined as de novo positive or ≥2-fold rise in the number of SPU after the first dose. A fluorescence-activated cell sorting (FACS)-based intracellular cytokine staining assay for interferon gamma or tumor necrosis factor alpha after stimulation with NY-ESO-1 peptide was also used and staining ≥2-fold above the baseline value was considered positive for T-cell responses. The number of participants that were anti-NY-ESO-1 T cell positive after induction with treatment is presented.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=26 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=20 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) T Cells After Induction With Treatment	14 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 36.1 months

Population: The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized.

ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all lesions in 2 consecutive observations ≥4 weeks apart) or a Partial Response (PR: ≥30% decrease in tumor burden compared with baseline in 2 observations ≥4 weeks apart) per RECIST 1.1 modified to use irRC confirmation and unidimensional tumor measurements as assessed by BICR. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR is presented.

Outcome measures

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 Participants Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=44 Participants Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Overall Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	2.2 Percentage of participants Interval 0.1 to 11.8	0.0 Percentage of participants Interval 0.0 to 8.0

Adverse Events

CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab

Serious events: 17 serious events

Other events: 42 other events

Deaths: 31 deaths

Atezolizumab

Serious events: 9 serious events

Other events: 42 other events

Deaths: 27 deaths

Serious adverse events

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 participants at risk Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=43 participants at risk Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Cardiac disorders Acute left ventricular failure	2.2% 1/45 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Atrial fibrillation	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Pericardial effusion	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Congenital, familial and genetic disorders Right ventricle outflow tract obstruction	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	4.4% 2/45 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Small intestinal haemorrhage	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Chest pain	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Influenza like illness	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Immune system disorders Drug hypersensitivity	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Influenza	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pyelonephritis	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Sepsis	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Staphylococcal bacteraemia	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Spinal compression fracture	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Hypoaesthesia	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Spinal cord compression	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.3% 4/43 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Urinary tract obstruction	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.4% 2/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.2% 1/45 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.

Other adverse events

Measure	CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab n=45 participants at risk Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by IV infusion Q3W for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered ID on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered IM and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.	Atezolizumab n=43 participants at risk Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.
Blood and lymphatic system disorders Anaemia	8.9% 4/45 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	14.0% 6/43 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Lymphadenopathy	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Sinus tachycardia	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	20.0% 9/45 • Number of events 10 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.6% 5/43 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	26.7% 12/45 • Number of events 15 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	16.3% 7/43 • Number of events 11 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	26.7% 12/45 • Number of events 15 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	25.6% 11/43 • Number of events 12 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	11.1% 5/45 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	16.3% 7/43 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Chest pain	8.9% 4/45 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Chills	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Fatigue	40.0% 18/45 • Number of events 31 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	23.3% 10/43 • Number of events 11 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Influenza like illness	6.7% 3/45 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Injection site pain	11.1% 5/45 • Number of events 5 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Injection site reaction	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	15.6% 7/45 • Number of events 8 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	14.0% 6/43 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Procedural pain	4.4% 2/45 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	14.0% 6/43 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Activated partial thromboplastin time prolonged	8.9% 4/45 • Number of events 10 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	6.7% 3/45 • Number of events 5 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.3% 4/43 • Number of events 5 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Aspartate aminotransferase increased	6.7% 3/45 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood alkaline phosphatase increased	8.9% 4/45 • Number of events 9 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.3% 4/43 • Number of events 5 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood lactate dehydrogenase increased	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	13.3% 6/45 • Number of events 8 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	6.7% 3/45 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.6% 5/43 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypocalcaemia	8.9% 4/45 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	8.9% 4/45 • Number of events 9 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	8.9% 4/45 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	14.0% 6/43 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	20.0% 9/45 • Number of events 12 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.3% 4/43 • Number of events 5 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 5/45 • Number of events 5 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	14.0% 6/43 • Number of events 8 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Headache	13.3% 6/45 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	16.3% 7/43 • Number of events 7 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Neuralgia	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.3% 4/43 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Insomnia	8.9% 4/45 • Number of events 4 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Acute kidney injury	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	17.8% 8/45 • Number of events 11 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.6% 5/43 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	26.7% 12/45 • Number of events 15 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	11.1% 5/45 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.3% 1/43 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	6.7% 3/45 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/45 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Dry skin	13.3% 6/45 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/43 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	11.1% 5/45 • Number of events 6 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.7% 2/43 • Number of events 2 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash pruritic	2.2% 1/45 • Number of events 1 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.0% 3/43 • Number of events 3 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Hypertension	11.1% 5/45 • Number of events 8 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.6% 5/43 • Number of events 5 • Up to approximately 36.1 months Populations: All participants who received ≥1 dose of study treatment for AEs; all randomized participants for all-cause mortality. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Manuscripts reporting the results of this clinical trial, abstracts, press releases, and other media presentations must be provided to the Sponsor for review and comment 30 days prior to submission for publication and may be delayed for up to an additional 30 days in order to ensure that confidential and proprietary data, and intellectual property rights, are protected. Co-authorship of publications will be discussed and mutually agreed upon before submission of a manuscript to a publisher.
• Publication restrictions are in place

Restriction type: OTHER