Trial Outcomes & Findings for Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases (NCT NCT03256344)

NCT ID: NCT03256344

Last Updated: 2024-05-14

Results Overview

Toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be related to either treatment: * Grade ≥ 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/μl) lasting ≥ 7 days * Grade ≥ 3 febrile neutropenia * Grade ≥ 4 thrombocytopenia * Grade ≥ 4 anemia * Grade ≥ 4 rash * Serious herpetic events * Grade ≥ 3 symptomatic hepatic toxicities that do not resolve to Grade ≤ 2 within 48 hours or Grade ≥ 3 asymptomatic hepatic toxicities that do not resolve to Grade ≤ 1 within 3 weeks of onset * Grade ≥ 3 non-hematologic, non-hepatic organ toxicity * Grade 5 toxicity (ie, death) * Any other intolerable toxicity leading to permanent discontinuation of treatment DLTs were to occur within the DLT evaluation period, defined as the period between the initial 10\^6 PFU/mL dose and 3 weeks following the initial 10\^8 PFU/mL dose or the start of Cycle 3, whichever occurred first.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: From Day 1 up to the start of Cycle 3 (each cycle is 21 days)
• Results posted on: 2024-05-14

Participant Flow

Participants were enrolled at 15 research centers in Australia, Belgium, Germany, Spain, Switzerland and the United States.

Participants were enrolled between 19 March 2018 and 03 December 2021. A total of 11 subjects with triple negative breast cancer were enrolled and 25 subjects with colorectal cancer.

Participant milestones

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Overall Study STARTED	11	25
Overall Study Received Talimogene Laherparepvec	8	23
Overall Study Received Atezolizumab	10	24
Overall Study Safety Analysis Set	10	24
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	10	25

Reasons for withdrawal

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Overall Study Death	6	22
Overall Study Withdrawal by Subject	3	3
Overall Study Sponsor Decision	1	0

Baseline Characteristics

Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases

Baseline characteristics by cohort

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=11 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=25 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	24 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 up to the start of Cycle 3 (each cycle is 21 days)

Population: DLT Analysis Set: All participants who had opportunity to receive treatment for 2 cycles from the time of initial dose of study treatment and who had received 2 doses of talimogene laherparepvec and 2 doses of atezolizumab in combination or had a DLT during the DLT-evaluation period.

Toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be related to either treatment:

• Grade ≥ 4 neutropenia (absolute neutrophil count [ANC] < 500/μl) lasting ≥ 7 days
• Grade ≥ 3 febrile neutropenia
• Grade ≥ 4 thrombocytopenia
• Grade ≥ 4 anemia
• Grade ≥ 4 rash
• Serious herpetic events
• Grade ≥ 3 symptomatic hepatic toxicities that do not resolve to Grade ≤ 2 within 48 hours or Grade ≥ 3 asymptomatic hepatic toxicities that do not resolve to Grade ≤ 1 within 3 weeks of onset
• Grade ≥ 3 non-hematologic, non-hepatic organ toxicity
• Grade 5 toxicity (ie, death)
• Any other intolerable toxicity leading to permanent discontinuation of treatment

DLTs were to occur within the DLT evaluation period, defined as the period between the initial 10^6 PFU/mL dose and 3 weeks following the initial 10^8 PFU/mL dose or the start of Cycle 3, whichever occurred first.

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=5 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=18 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

ORR was defined as the incidence rate of either a complete response (CR) or partial response (PR) based on modified immune-related response criteria simulating Response Evaluation Criteria in Solid Tumors(irRC-RECIST) criteria. A CR was a complete disappearance of all lesions and a PR was a decrease in tumor burden 30% or more relative to baseline.

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Objective Response Rate (ORR)	10.0 Percentage of Participants Interval 0.3 to 44.5	0.0 Percentage of Participants Interval 0.0 to 14.2

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

BOR was defined as the best visit response based on modified irRC-RECIST criteria:

• CR: a complete disappearance of all lesions
• PR: a decrease in tumor burden 30% or more relative to baseline
• Stable disease (SD): neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for progressive disease (PD)
• PD: an increase in tumor burden of 20% or more and at least 5 mm absolute increase relative to nadir (minimum recorded tumor burden)
• Unevaluable (UE): any lesion present at baseline which was not assessed or was unable to be evaluated leading to an inability to determine the status of that particular tumor

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Best Overall Response (BOR) CR	0 Participants	0 Participants
Best Overall Response (BOR) PR	1 Participants	0 Participants
Best Overall Response (BOR) SD	1 Participants	1 Participants
Best Overall Response (BOR) PD	3 Participants	4 Participants
Best Overall Response (BOR) UE	3 Participants	14 Participants
Best Overall Response (BOR) Not done	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Responders in Safety Analysis Set: All participants in safety analysis set who received at least 1 dose of talimogene laherparepvec or atezolizumab who had a best overall response of CR/PR at the time of analysis.

DOR was defined as the time from the date of an initial response that is subsequently confirmed to the earlier of PD per modified irRC RECIST or death. Participants who have not ended their response at the time of analysis were censored at the last evaluable tumor assessment.

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=1 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Duration of Response (DOR)	NA Months Not calculable as only 1 participant achieved response.	—

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Injected Lesion Analysis Set: Any target lesion and new measurable lesion that was injected from the participants who had received at least 1 dose of talimogene laherparepvec or atezolizumab.

Responses for individual tumor lesions for hepatic and non-hepatic tumors injected wtih treatment were assessed for the following responses:

• Lesion complete response rate (L-CRR): Disappearance of lesion
• Lesion partial response rate (L-PRR): Decrease in tumor burden 30% or more relative to baseline
• Lesion objective response rate (L-ORR): Either a L-CRR or L-PRR based on modified irRC-RECIST criteria

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=13 Lesions Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=28 Lesions Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Lesion Level Response in Injected Tumor Lesions L-CRR - Hepatic	0 Lesions Interval 0.0 to 24.7	0 Lesions Interval 0.0 to 12.3
Lesion Level Response in Injected Tumor Lesions L-CRR - Overall	0 Lesions Interval 0.0 to 24.7	0 Lesions Interval 0.0 to 12.3
Lesion Level Response in Injected Tumor Lesions L-PRR - Overall	1 Lesions Interval 0.2 to 36.0	0 Lesions Interval 0.0 to 12.3
Lesion Level Response in Injected Tumor Lesions L-ORR - Hepatic	1 Lesions Interval 0.2 to 36.0	0 Lesions Interval 0.0 to 12.3
Lesion Level Response in Injected Tumor Lesions L-ORR - Overall	1 Lesions Interval 0.2 to 36.0	0 Lesions Interval 0.0 to 12.3
Lesion Level Response in Injected Tumor Lesions L-PRR - Hepatic	1 Lesions Interval 0.2 to 36.0	0 Lesions Interval 0.0 to 12.3

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Uninjected Lesion Analysis Set: Any target lesion and new measurable lesion that was never injected from the participants who had received at least 1 dose of talimogene laherparepvec or atezolizumab.

Responses for individual tumor lesions for hepatic and non-hepatic tumors that were not injected with treatment were assessed for the following responses:

• L-CRR: Disappearance of lesion
• L-PRR: Decrease in tumor burden 30% or more relative to baseline
• L-ORR: Either a L-CRR or L-PRR based on modified irRC-RECIST criteria

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=24 Lesions Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=94 Lesions Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Lesion Level Response in Uninjected Tumor Lesions L-CRR - Hepatic	0 Lesions Interval 0.0 to 21.8	0 Lesions Interval 0.0 to 7.1
Lesion Level Response in Uninjected Tumor Lesions L-CRR - Non-hepatic	0 Lesions Interval 0.0 to 33.6	0 Lesions Interval 0.0 to 8.0
Lesion Level Response in Uninjected Tumor Lesions L-CRR - Overall	0 Lesions Interval 0.0 to 14.2	0 Lesions Interval 0.0 to 3.8
Lesion Level Response in Uninjected Tumor Lesions L-PRR - Hepatic	0 Lesions Interval 0.0 to 21.8	1 Lesions Interval 0.1 to 10.6
Lesion Level Response in Uninjected Tumor Lesions L-PRR - Non-hepatic	1 Lesions Interval 0.3 to 48.2	0 Lesions Interval 0.0 to 8.0
Lesion Level Response in Uninjected Tumor Lesions L-PRR - Overall	1 Lesions Interval 0.1 to 21.1	1 Lesions Interval 0.0 to 5.8
Lesion Level Response in Uninjected Tumor Lesions L-ORR - Non-hepatic	1 Lesions Interval 0.3 to 48.2	0 Lesions Interval 0.0 to 8.0
Lesion Level Response in Uninjected Tumor Lesions L-ORR - Hepatic	0 Lesions Interval 0.0 to 21.8	1 Lesions Interval 0.1 to 10.6
Lesion Level Response in Uninjected Tumor Lesions L-ORR - Overall	1 Lesions Interval 0.1 to 21.1	1 Lesions Interval 0.0 to 5.8

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

DRR was defined as the percentage of participants with an objective response with a DOR of at least 6 months.

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Durable Response Rate (DRR)	0.0 Percentage of Participants Interval 0.0 to 30.8	0.0 Percentage of Participants Interval 0.0 to 14.2

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

DCR was defined as the percentage of participants that have a best overall response in one of the following categories: CR/PR/SD.

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Disease Control Rate (DCR)	20.0 Percentage of Participants Interval 2.5 to 55.6	4.2 Percentage of Participants Interval 0.1 to 21.1

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

PFS was defined as time from first dose to the date of first of confirmed disease progression per modified irRC-RECIST criteria, or death (whichever occurred first). Results were estimated using the Kaplan-Meier method.

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Progression-free Survival (PFS)	5.4 Months Interval 1.0 to Upper limit was not estimable.	3.1 Months Interval 2.1 to 5.2

SECONDARY outcome

Timeframe: Every 12 weeks (± 28 days) up to approximately 3.5 years.

Population: Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

OS was defined as the time from the date of first dose to the date of death from any cause. Results were estimated using the Kaplan-Meier method.

Outcome measures

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 Participants Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 Participants Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Overall Survival (OS)	19.2 Months Interval 1.5 to Upper limit was not estimable.	4.0 Months Interval 2.8 to 6.6

Adverse Events

Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC)

Serious events: 4 serious events

Other events: 8 other events

Deaths: 6 deaths

Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC)

Serious events: 12 serious events

Other events: 23 other events

Deaths: 22 deaths

Serious adverse events

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 participants at risk Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 participants at risk Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Cardiac disorders Cardiac failure	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Cardiac disorders Myocarditis	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Constipation	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Pain	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Pyrexia	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	12.5% 3/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Hepatobiliary disorders Hepatic haematoma	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Immune system disorders Cytokine release syndrome	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Immune system disorders Hypersensitivity	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Infections and infestations Abdominal infection	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Infections and infestations Pulmonary sepsis	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Infections and infestations Viral infection	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Investigations Electrocardiogram QT prolonged	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Investigations Platelet count decreased	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Vascular disorders Hypertension	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Vascular disorders Orthostatic hypotension	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour hyperprogression	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

Other adverse events

Measure	Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) n=10 participants at risk Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.	Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) n=24 participants at risk Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10\^6 PFU/mL on Day 1 of Cycle 1 and 10\^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Cardiac disorders Tachycardia	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	20.8% 5/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Ear and labyrinth disorders Ear congestion	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Ear and labyrinth disorders Ear pain	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Eye disorders Dry eye	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Abdominal pain lower	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	12.5% 3/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Constipation	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Diarrhoea	30.0% 3/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Flatulence	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Impaired gastric emptying	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Nausea	30.0% 3/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	20.8% 5/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Gastrointestinal disorders Vomiting	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	33.3% 8/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Asthenia	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	16.7% 4/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Chills	40.0% 4/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Fatigue	40.0% 4/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	20.8% 5/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders General physical health deterioration	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Influenza like illness	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Injection site pain	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	12.5% 3/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Oedema peripheral	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	20.8% 5/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
General disorders Pyrexia	70.0% 7/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	58.3% 14/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Hepatobiliary disorders Hepatic pain	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Immune system disorders Cytokine release syndrome	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Infections and infestations Herpes virus infection	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Infections and infestations Urinary tract infection	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Injury, poisoning and procedural complications Contusion	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Injury, poisoning and procedural complications Infusion related reaction	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Investigations Blood alkaline phosphatase increased	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Investigations Hepatic enzyme increased	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Investigations Lymphocyte count decreased	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Investigations Platelet count decreased	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	20.8% 5/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	12.5% 3/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Musculoskeletal and connective tissue disorders Back pain	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Musculoskeletal and connective tissue disorders Bone pain	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Musculoskeletal and connective tissue disorders Neck pain	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Nervous system disorders Dizziness	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Nervous system disorders Headache	30.0% 3/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	12.5% 3/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Nervous system disorders Lethargy	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Nervous system disorders Presyncope	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Psychiatric disorders Anxiety	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Renal and urinary disorders Dysuria	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Reproductive system and breast disorders Vulvovaginal pruritus	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	12.5% 3/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Skin and subcutaneous tissue disorders Pruritus	20.0% 2/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	8.3% 2/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Skin and subcutaneous tissue disorders Rash	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	4.2% 1/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Skin and subcutaneous tissue disorders Rash macular	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
Vascular disorders Hot flush	10.0% 1/10 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.	0.00% 0/24 • Day 1 up to approximately 3.5 years. All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER