Trial Outcomes & Findings for Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611 (NCT NCT02509507)

NCT ID: NCT02509507

Last Updated: 2024-08-06

Results Overview

All toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe or medically significant but not immediately life threatening * Grade 4: Life threatening consequences * Grade 5: Death related to adverse event (AE) The occurrence of specific pre-defined toxicities during the DLT evaluation period were considered a DLT if judged by the investigator to be related to talimogene laherparepvec and/or pembrolizumab. All Grade 5 toxicities, intolerable toxicities that lead to permanent discontinuation of talimogene laherparepvec and/or pembrolizumab and Grade 3 or higher AEs related to talimogene laherparepvec and/or pembrolizumab that resulted in a study treatment delay by \> 2 weeks were considered DLTs.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

127 participants

Primary outcome timeframe

Cycle 1 and Cycle 2: Day 1 to Day 21

Results posted on

2024-08-06

Participant Flow

127 participants were enrolled at 22 centers in Australia, Europe, South Korea and the United States from February 2016 to July 2023. As of protocol amendment 6 (dated 26 October 2021), intrahepatic injections of talimogene laherparepvec were no longer performed.

Of the 190 participants screened, 127 participants were enrolled and received study treatment.

Participant milestones

Participant milestones
Measure
Part 1: Monotherapy Group A
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Overall Study
STARTED
23
5
24
22
10
18
10
5
10
Overall Study
Received Talimogene Laherparepvec
23
5
24
22
10
18
10
5
10
Overall Study
Received Pembrolizumab
0
0
24
22
10
18
10
5
10
Overall Study
COMPLETED
0
1
1
4
1
1
1
1
1
Overall Study
NOT COMPLETED
23
4
23
18
9
17
9
4
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1: Monotherapy Group A
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Overall Study
Death
21
3
22
14
8
12
5
4
8
Overall Study
Lost to Follow-up
0
1
0
0
0
2
0
0
0
Overall Study
Withdrawal by Subject
2
0
1
4
1
3
4
0
1

Baseline Characteristics

Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Total
n=127 Participants
Total of all reporting groups
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race/Ethnicity, Customized
White
20 Participants
n=5 Participants
4 Participants
n=7 Participants
23 Participants
n=5 Participants
14 Participants
n=4 Participants
10 Participants
n=21 Participants
15 Participants
n=10 Participants
7 Participants
n=115 Participants
4 Participants
n=24 Participants
9 Participants
n=42 Participants
106 Participants
n=42 Participants
Age, Customized
18 - 64 years
16 Participants
n=5 Participants
3 Participants
n=7 Participants
17 Participants
n=5 Participants
10 Participants
n=4 Participants
8 Participants
n=21 Participants
15 Participants
n=10 Participants
5 Participants
n=115 Participants
4 Participants
n=24 Participants
6 Participants
n=42 Participants
84 Participants
n=42 Participants
Age, Customized
65 - 74 years
7 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
8 Participants
n=4 Participants
2 Participants
n=21 Participants
2 Participants
n=10 Participants
2 Participants
n=115 Participants
1 Participants
n=24 Participants
4 Participants
n=42 Participants
33 Participants
n=42 Participants
Age, Customized
75 - 84 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
3 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
10 Participants
n=42 Participants
Age, Customized
>= 85 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
2 Participants
n=7 Participants
10 Participants
n=5 Participants
5 Participants
n=4 Participants
10 Participants
n=21 Participants
18 Participants
n=10 Participants
3 Participants
n=115 Participants
2 Participants
n=24 Participants
4 Participants
n=42 Participants
65 Participants
n=42 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
3 Participants
n=7 Participants
14 Participants
n=5 Participants
17 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
7 Participants
n=115 Participants
3 Participants
n=24 Participants
6 Participants
n=42 Participants
62 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=10 Participants
1 Participants
n=115 Participants
1 Participants
n=24 Participants
0 Participants
n=42 Participants
8 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=5 Participants
5 Participants
n=7 Participants
23 Participants
n=5 Participants
21 Participants
n=4 Participants
10 Participants
n=21 Participants
16 Participants
n=10 Participants
9 Participants
n=115 Participants
4 Participants
n=24 Participants
10 Participants
n=42 Participants
119 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
8 Participants
n=4 Participants
0 Participants
n=21 Participants
3 Participants
n=10 Participants
3 Participants
n=115 Participants
1 Participants
n=24 Participants
1 Participants
n=42 Participants
19 Participants
n=42 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants

PRIMARY outcome

Timeframe: Cycle 1 and Cycle 2: Day 1 to Day 21

Population: DLT Analysis Set: Participants who had at least 1 dose of planned monotherapy or combination treatment and had the opportunity to be on treatment for at least 6 weeks from the initial dosing of study treatment \& received at least 1 additional dose of monotherapy or combination or experienced a DLT during the DLT-evaluation period.

All toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe or medically significant but not immediately life threatening * Grade 4: Life threatening consequences * Grade 5: Death related to adverse event (AE) The occurrence of specific pre-defined toxicities during the DLT evaluation period were considered a DLT if judged by the investigator to be related to talimogene laherparepvec and/or pembrolizumab. All Grade 5 toxicities, intolerable toxicities that lead to permanent discontinuation of talimogene laherparepvec and/or pembrolizumab and Grade 3 or higher AEs related to talimogene laherparepvec and/or pembrolizumab that resulted in a study treatment delay by \> 2 weeks were considered DLTs.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=18 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=20 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=19 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=8 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=11 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=5 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=4 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=9 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
2 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Up to 154 weeks

Population: Full Analysis Set (Part 2): Included all participants in Part 2 who received at least 1 dose of talimogene laherparepvec and at least 1 dose of pembrolizumab in combination.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per modified irRC-RECIST. * CR: Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=10 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=18 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=10 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2 Only: Objective Response Rate (ORR) Per Modified Immune-related Response Criteria Simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
10.0 percentage of participants
Interval 0.3 to 44.5
16.7 percentage of participants
Interval 3.6 to 41.4
10.0 percentage of participants
Interval 0.3 to 44.5
20.0 percentage of participants
Interval 0.5 to 71.6
0.0 percentage of participants
Interval 0.0 to 30.8

PRIMARY outcome

Timeframe: Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks in Part 2.

Population: Safety Analysis Set (Part 2): Included all participants in Part 2 who have received at least 1 dose of talimogene laherparepvec or at least 1 dose of pembrolizumab.

A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. A treatment-related TEAE was defined as a TEAE that was suspected to be related to the study treatment.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=10 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=18 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=10 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs
10 Participants
17 Participants
9 Participants
5 Participants
10 Participants
Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Treatment-related TEAEs
10 Participants
12 Participants
4 Participants
5 Participants
10 Participants

SECONDARY outcome

Timeframe: Up to 297 weeks

Population: Full Analysis Set (Part 1): Included all participants in Part 1 who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts.

ORR was defined as the percentage of participants with a best overall response of CR or PR per modified irRC-RECIST. * CR: Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1 Only: ORR Per Modified irRC-RECIST
0.0 percentage of participants
Interval 0.0 to 14.8
0.0 percentage of participants
Interval 0.0 to 52.2
8.3 percentage of participants
Interval 1.0 to 27.0
13.6 percentage of participants
Interval 2.9 to 34.9

SECONDARY outcome

Timeframe: Up to 297 weeks

Population: Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2.

BOR was defined as the number of participants with a best visit response in the following order: CR, PR, stable disease (SD), progressive disease (PD), or unevaluable (UE) as per modified irRC-RECIST. * CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. * SD: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. * PD: Increase in tumor burden ≥ 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD. * UE: Any lesion present at baseline which was not assessed or was unable to be evaluated.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Best Overall Response (BOR) Per Modified irRC-RECIST
CR
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response (BOR) Per Modified irRC-RECIST
PR
0 Participants
0 Participants
2 Participants
3 Participants
1 Participants
1 Participants
1 Participants
1 Participants
0 Participants
Best Overall Response (BOR) Per Modified irRC-RECIST
SD
1 Participants
1 Participants
4 Participants
6 Participants
1 Participants
1 Participants
1 Participants
2 Participants
3 Participants
Best Overall Response (BOR) Per Modified irRC-RECIST
PD
7 Participants
1 Participants
10 Participants
3 Participants
3 Participants
5 Participants
2 Participants
0 Participants
1 Participants
Best Overall Response (BOR) Per Modified irRC-RECIST
UE
13 Participants
3 Participants
7 Participants
10 Participants
5 Participants
6 Participants
4 Participants
2 Participants
5 Participants
Best Overall Response (BOR) Per Modified irRC-RECIST
Not Done
2 Participants
0 Participants
1 Participants
0 Participants
0 Participants
3 Participants
2 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Up to 297 weeks

Population: Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2.

DRR per modified irRC-RECIST was defined as the percentage of participants with an objective response (CR/PR) with a duration of response of at least 6 months. * CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Durable Response Rate (DRR) Per Modified irRC-RECIST
0.0 percentage of participants
Interval 0.0 to 14.8
0.0 percentage of participants
Interval 0.0 to 52.2
8.3 percentage of participants
Interval 1.0 to 27.0
9.1 percentage of participants
Interval 1.1 to 29.2
10.0 percentage of participants
Interval 0.3 to 44.5
11.1 percentage of participants
Interval 1.4 to 34.7
10.0 percentage of participants
Interval 0.3 to 44.5
20.0 percentage of participants
Interval 0.5 to 71.6
0.0 percentage of participants
Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: Up to 297 weeks

Population: Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. Only participants who had a BOR of CR/PR were included.

DOR per modified irRC-RECIST was defined as the time from the date of an initial response (CR/PR) that was subsequently confirmed to the earlier of PD or death. DOR was estimated using the Kaplan-Meier method. * CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. * PD: Increase in tumor burden ≥ 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=2 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=3 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=1 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=3 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=1 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=1 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Duration of Response (DOR) Per Modified irRC-RECIST
16.8 months
Interval 12.2 to
Due to limited number of events, upper limit was not reached.
8.9 months
Interval 4.3 to
Due to limited number of events, upper limit was not reached.
NA months
Due to limited number of events, median and upper/lower limits were not reached.
23.1 months
Interval 5.1 to
Due to limited number of events, upper limit was not reached.
NA months
Due to limited number of events, median and upper/lower limits were not reached.
NA months
Due to limited number of events, median and upper/lower limits were not reached.

SECONDARY outcome

Timeframe: Up to 297 weeks

Population: Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2.

DCR per modified irRC-RECIST was defined as percentage of participants that had a BOR in 1 of the following: CR, PR or SD. * CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. * SD: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Disease Control Rate (DCR) Per Modified irRC-RECIST
4.3 percentage of participants
Interval 0.1 to 21.9
20.0 percentage of participants
Interval 0.5 to 71.6
25.0 percentage of participants
Interval 9.8 to 46.7
40.9 percentage of participants
Interval 20.7 to 63.6
20.0 percentage of participants
Interval 2.5 to 55.6
22.2 percentage of participants
Interval 6.4 to 47.6
20.0 percentage of participants
Interval 2.5 to 55.6
60.0 percentage of participants
Interval 14.7 to 94.7
30.0 percentage of participants
Interval 6.7 to 65.2

SECONDARY outcome

Timeframe: Up to 297 weeks

Population: Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2.

PFS was defined as the time from first dose to the date of first of PD per modified irRC-RECIST criteria, or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Participants that did not have an event of death or disease progression were censored at the latter of their last evaluable tumor assessment date or first dose date. * PD: Increase in tumor burden ≥ 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Progression Free Survival (PFS) Per Modified irRC-RECIST
2.3 months
Interval 1.9 to 9.0
3.9 months
Interval 1.9 to
Due to limited number of events, data were not evaluable.
2.0 months
Interval 1.9 to 6.2
8.1 months
Interval 3.2 to 13.2
6.1 months
Interval 1.6 to 20.5
2.9 months
Interval 1.2 to 10.2
5.4 months
Interval 2.2 to
Due to limited number of events, data were not evaluable.
16.4 months
Interval 5.4 to
Due to limited number of events, data were not evaluable.
8.8 months
Interval 2.4 to 12.5

SECONDARY outcome

Timeframe: Up to 297 weeks

Population: Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2.

OS was defined as the time from the date of first dose date to the date of death from any cause. OS time was censored at the last date the participant was known to be alive when the confirmation of death was absent or unknown, or at the date 24 months after the last participant enrolled if the last known to be alive/death date was beyond it. One month = 365.25/12 days. OS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Overall Survival (OS)
8.7 months
Interval 2.7 to 17.1
9.1 months
Interval 3.9 to
Due to limited number of events, upper limit was not reached.
7.8 months
Interval 4.4 to 14.2
12.8 months
Interval 6.8 to 29.5
9.1 months
Interval 2.4 to 20.5
10.2 months
Interval 2.7 to 27.2
9.6 months
Interval 2.3 to
Due to limited number of events, upper limit was not reached.
16.4 months
Interval 5.4 to
Due to limited number of events, upper limit was not reached.
11.2 months
Interval 2.4 to 18.9

SECONDARY outcome

Timeframe: Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 34.1 weeks and pembrolizumab treatment was 98.3 weeks in Part 1.

Population: Safety Analysis Set (Part 1): Included all participants in Part 1 who have received at least 1 dose of talimogene laherparepvec or at least 1 dose of pembrolizumab.

A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. A treatment-related TEAE was defined as a TEAE that was suspected to be related to the study treatment.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1 Only: Number of Participants Who Experienced a TEAE
TEAEs
23 Participants
5 Participants
24 Participants
21 Participants
Part 1 Only: Number of Participants Who Experienced a TEAE
Treatment-related TEAEs
23 Participants
5 Participants
22 Participants
20 Participants

SECONDARY outcome

Timeframe: Week 1 to Week 10

Population: Blood Evaluable Analysis Set: Included all participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one post dose blood sample collected.

Blood samples were tested using real-time polymerase chain reaction (qPCR). Detectable DNA was defined as a positive result by qPCR analysis.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) in Blood
100.0 percentage of participants
Interval 85.2 to 100.0
100.0 percentage of participants
Interval 47.8 to 100.0
100.0 percentage of participants
Interval 85.8 to 100.0
95.5 percentage of participants
Interval 77.2 to 99.9
90.0 percentage of participants
Interval 55.5 to 99.7
88.9 percentage of participants
Interval 65.3 to 98.6
50.0 percentage of participants
Interval 18.7 to 81.3
60.0 percentage of participants
Interval 14.7 to 94.7
100.0 percentage of participants
Interval 69.2 to 100.0

SECONDARY outcome

Timeframe: Week 1 to Week 10

Population: Urine Evaluable Analysis Set: Included all participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one post dose urine sample collected.

Urine samples were tested using qPCR. Detectable DNA was defined as a positive result by qPCR analysis.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Urine
34.8 percentage of participants
Interval 16.4 to 57.3
40.0 percentage of participants
Interval 5.3 to 85.3
37.5 percentage of participants
Interval 18.8 to 59.4
54.5 percentage of participants
Interval 32.2 to 75.6
10.0 percentage of participants
Interval 0.3 to 44.5
27.8 percentage of participants
Interval 9.7 to 53.5
20.0 percentage of participants
Interval 2.5 to 55.6
0.0 percentage of participants
Interval 0.0 to 52.2
30.0 percentage of participants
Interval 6.7 to 65.2

SECONDARY outcome

Timeframe: Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days.

Population: Blood Clearance Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least 2 post dose samples, collected within the same dosing cycle. Participants must have had at least 1 positive sample and at least 1 subsequent sample at any time during the cycle. All participants included in the overall number of participants contributed analyzed data.

Blood samples were tested using qPCR. A participant was defined as having cleared talimogene laherparepvec if a negative qPCR in a sample was obtained following a prior positive test and if there were no subsequent positive test results in the same cycle.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=21 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=9 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=16 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=5 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=3 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Clearance of Talimogene Laherparepvec in Blood
Cycle 2, Day 1 Pre-dose
73.9 percentage of participants
Interval 51.6 to 89.8
100.0 percentage of participants
Interval 47.8 to 100.0
52.2 percentage of participants
Interval 30.6 to 73.2
95.2 percentage of participants
Interval 76.2 to 99.9
85.7 percentage of participants
Interval 42.1 to 99.6
80.0 percentage of participants
Interval 51.9 to 95.7
66.7 percentage of participants
Interval 9.4 to 99.2
66.7 percentage of participants
Interval 9.4 to 99.2
60.0 percentage of participants
Interval 26.2 to 87.8
Percentage of Participants With Clearance of Talimogene Laherparepvec in Blood
Cycle 3, Day 1 Pre-dose
66.7 percentage of participants
Interval 41.0 to 86.7
100.0 percentage of participants
Interval 47.8 to 100.0
70.0 percentage of participants
Interval 45.7 to 88.1
100.0 percentage of participants
Interval 81.5 to 100.0
77.8 percentage of participants
Interval 40.0 to 97.2
75.0 percentage of participants
Interval 42.8 to 94.5
75.0 percentage of participants
Interval 19.4 to 99.4
100.0 percentage of participants
Interval 15.8 to 100.0
70.0 percentage of participants
Interval 34.8 to 93.3
Percentage of Participants With Clearance of Talimogene Laherparepvec in Blood
Cycle 4, Day 1 Pre-dose
66.7 percentage of participants
Interval 9.4 to 99.2
37.5 percentage of participants
Interval 8.5 to 75.5
100.0 percentage of participants
Interval 2.5 to 100.0

SECONDARY outcome

Timeframe: Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days.

Population: Urine Clearance Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least 2 post dose samples, collected within the same dosing cycle. Participants must have had at least 1 positive sample and at least 1 subsequent sample at any time during the cycle. All participants included in the overall number of participants contributed analyzed data.

Urine samples were tested using qPCR. A participant was defined as having cleared talimogene laherparepvec if a negative qPCR in a sample was obtained following a prior positive test and if there were no subsequent positive test results in the same cycle.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=8 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=2 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=9 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=11 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=1 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=5 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=1 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=3 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Clearance of Talimogene Laherparepvec in Urine
Cycle 2, Day 1 Pre-dose
100.0 percentage of participants
Interval 29.2 to 100.0
100.0 percentage of participants
Interval 2.5 to 100.0
80.0 percentage of participants
Interval 28.4 to 99.5
100.0 percentage of participants
Interval 29.2 to 100.0
100.0 percentage of participants
Interval 29.2 to 100.0
0.0 percentage of participants
Interval 0.0 to 97.5
100.0 percentage of participants
Interval 15.8 to 100.0
Percentage of Participants With Clearance of Talimogene Laherparepvec in Urine
Cycle 3, Day 1 Pre-dose
100.0 percentage of participants
Interval 59.0 to 100.0
100.0 percentage of participants
Interval 2.5 to 100.0
100.0 percentage of participants
Interval 47.8 to 100.0
100.0 percentage of participants
Interval 69.2 to 100.0
100.0 percentage of participants
Interval 2.5 to 100.0
100.0 percentage of participants
Interval 29.2 to 100.0
100.0 percentage of participants
Interval 15.8 to 100.0

SECONDARY outcome

Timeframe: Week 1 to Week 10

Population: Skin Surface of Injections Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the skin surface of injections.

The number of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of skin surface of injections. Detectable DNA was defined as a positive result by qPCR analysis.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=16 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=4 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Surface of Injection Site
69.6 percentage of participants
Interval 47.1 to 86.8
60.0 percentage of participants
Interval 14.7 to 94.7
79.2 percentage of participants
Interval 57.8 to 92.9
72.7 percentage of participants
Interval 49.8 to 89.3
60.0 percentage of participants
Interval 26.2 to 87.8
68.8 percentage of participants
Interval 41.3 to 89.0
80.0 percentage of participants
Interval 44.4 to 97.5
100.0 percentage of participants
Interval 39.8 to 100.0
60.0 percentage of participants
Interval 26.2 to 87.8

SECONDARY outcome

Timeframe: Week 1 to Week 10

Population: Skin Surface of Injections Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the skin surface of injections. Only participants with a positive surface of injection site qPCR test were included.

The percentage of participants with detectable virus were evaluated from swabs of skin surface of injections. Detectable virus was defined as a positive result by TCID50.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=16 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=3 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=18 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=16 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=6 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=11 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=8 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=4 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=6 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Surface of Injection Site
0.0 percentage of participants
Interval 0.0 to 20.6
0.0 percentage of participants
Interval 0.0 to 70.8
0.0 percentage of participants
Interval 0.0 to 18.5
0.0 percentage of participants
Interval 0.0 to 20.6
16.7 percentage of participants
Interval 0.4 to 64.1
0.0 percentage of participants
Interval 0.0 to 28.5
12.5 percentage of participants
Interval 0.3 to 52.7
0.0 percentage of participants
Interval 0.0 to 60.2
0.0 percentage of participants
Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: Week 1 to Week 7

Population: Exterior of Occlusive Dressing Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.

The percentage of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of the exterior of the occlusive dressing. Detectable DNA was defined as a positive result by qPCR analysis.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=21 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=9 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=12 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=9 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=7 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Exterior of the Occlusive Dressing
30.4 percentage of participants
Interval 13.2 to 52.9
20.0 percentage of participants
Interval 0.5 to 71.6
39.1 percentage of participants
Interval 19.7 to 61.5
61.9 percentage of participants
Interval 38.4 to 81.9
66.7 percentage of participants
Interval 29.9 to 92.5
33.3 percentage of participants
Interval 9.9 to 65.1
44.4 percentage of participants
Interval 13.7 to 78.8
60.0 percentage of participants
Interval 14.7 to 94.7
14.3 percentage of participants
Interval 0.4 to 57.9

SECONDARY outcome

Timeframe: Week 1 to Week 7

Population: Exterior of Occlusive Dressing Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing. Only participants with a positive exterior of occlusive dressing qPCR test were included.

The percentage of participants with detectable virus were evaluated from swabs of the exterior of the occlusive dressings. Detectable virus was defined as a positive result by TCID50.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=7 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=1 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=9 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=13 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=6 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=4 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=4 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=3 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=1 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Exterior of the Occlusive Dressing
0.0 percentage of participants
Interval 0.0 to 41.0
0.0 percentage of participants
Interval 0.0 to 97.5
0.0 percentage of participants
Interval 0.0 to 33.6
0.0 percentage of participants
Interval 0.0 to 24.7
16.7 percentage of participants
Interval 0.4 to 64.1
0.0 percentage of participants
Interval 0.0 to 60.2
0.0 percentage of participants
Interval 0.0 to 60.2
0.0 percentage of participants
Interval 0.0 to 70.8
0.0 percentage of participants
Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Part 1: Week 1 to Week 37. Part 2: Week 1 to Week 43

Population: Oral Mucosa Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the oral mucosa.

The percentage of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of the oral mucosa. Detectable DNA was defined as a positive result by qPCR analysis.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=23 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 Participants
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=16 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Oral Mucosa
0.0 percentage of participants
Interval 0.0 to 14.8
0.0 percentage of participants
Interval 0.0 to 52.2
29.2 percentage of participants
Interval 12.6 to 51.1
4.5 percentage of participants
Interval 0.1 to 22.8
0.0 percentage of participants
Interval 0.0 to 30.8
12.5 percentage of participants
Interval 1.6 to 38.3
10.0 percentage of participants
Interval 0.3 to 44.5
60.0 percentage of participants
Interval 14.7 to 94.7
10.0 percentage of participants
Interval 0.3 to 44.5

SECONDARY outcome

Timeframe: Week 1 to Week 7

Population: Oral Mucosa Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the oral mucosa. Only participants with a positive oral mucosa qPCR test were included.

The percentage of participants with detectable virus were evaluated from swabs of the oral mucosa. Detectable virus was defined as a positive result by TCID50.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=7 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=1 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=2 Participants
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=1 Participants
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=3 Participants
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=1 Participants
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Oral Mucosa
0.0 percentage of participants
Interval 0.0 to 41.0
0.0 percentage of participants
Interval 0.0 to 97.5
0.0 percentage of participants
Interval 0.0 to 84.2
0.0 percentage of participants
Interval 0.0 to 97.5
0.0 percentage of participants
Interval 0.0 to 70.8
0.0 percentage of participants
Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Day 1 to 30 days post-last dose of talimogene laherparepvec. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks.

Population: Reactive Swab Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions that were suspected to be herpetic in origin.

The percentage of participants with positive qPCR were evaluated in any swab of a lesion suspected to be herpetic in origin. Detectable DNA was defined as a positive result by qPCR analysis. Participants returned to the clinic within 3 days of the occurrence of reportable lesion suspected to be herpetic in origin such as cold sores or vesicles. The lesion was evaluated by the Investigator and swabbed if herpes simplex virus infection was suspected.

Outcome measures

Outcome measures
Measure
Part 1: Monotherapy Group A
n=2 Participants
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=1 Participants
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Lesions Suspected to be Herpetic in Origin
0.0 percentage of participants
Interval 0.0 to 84.2
100.0 percentage of participants
Interval 2.5 to 100.0

Adverse Events

Part 1: Monotherapy Group A

Serious events: 10 serious events
Other events: 23 other events
Deaths: 21 deaths

Part 1: Monotherapy Group B

Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths

Part 1: Combination Therapy Group A

Serious events: 10 serious events
Other events: 24 other events
Deaths: 22 deaths

Part 1: Combination Therapy Group B

Serious events: 11 serious events
Other events: 21 other events
Deaths: 14 deaths

Part 2: Hormone Receptor Positive Breast Cancer (HRBC)

Serious events: 4 serious events
Other events: 10 other events
Deaths: 8 deaths

Part 2: Triple Negative Breast Cancer (TNBC)

Serious events: 7 serious events
Other events: 15 other events
Deaths: 13 deaths

Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)

Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths

Part 2: Basal Cell Carcinoma (BCC)

Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths

Part 2: Colorectal Adenocarcinoma (CRC)

Serious events: 3 serious events
Other events: 10 other events
Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure
Part 1: Monotherapy Group A
n=23 participants at risk
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 participants at risk
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 participants at risk
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 participants at risk
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 participants at risk
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 participants at risk
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 participants at risk
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 participants at risk
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 participants at risk
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Gastrointestinal disorders
Nausea
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Cardiac disorders
Acute coronary syndrome
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Cardiac disorders
Pericarditis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Abdominal pain
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Hernial eventration
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Ileus
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Chest pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Fatigue
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Pyrexia
13.0%
3/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
16.7%
4/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Cholestasis
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Hepatic cirrhosis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Hepatic haemorrhage
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Hepatitis cholestatic
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Immune system disorders
Cytokine release syndrome
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Bacterial infection
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Haemophilus infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Peritonitis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Pseudomonal skin infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Respiratory tract infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Soft tissue infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Urinary tract infection bacterial
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Alanine aminotransferase increased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Aspartate aminotransferase increased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Blood alkaline phosphatase increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Procalcitonin increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Transaminases increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Weight decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Dehydration
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Soft tissue haemorrhage
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Aphasia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Spinal cord compression
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Syncope
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Psychiatric disorders
Confusional state
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Renal and urinary disorders
Acute kidney injury
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Renal and urinary disorders
Glomerulonephritis proliferative
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Renal and urinary disorders
Haematuria
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Renal and urinary disorders
Urinary retention
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Vascular disorders
Haematoma
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Vascular disorders
Haemorrhage
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Vascular disorders
Hypotension
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Vascular disorders
Hypovolaemic shock
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Intestinal perforation
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.

Other adverse events

Other adverse events
Measure
Part 1: Monotherapy Group A
n=23 participants at risk
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Monotherapy Group B
n=5 participants at risk
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 \& 2 and up to a volume of 8 mL in Cohorts 3 \& 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohorts 1 \& 4) or 10\^8 PFU/mL (Cohorts 2 \& 3).
Part 1: Combination Therapy Group A
n=24 participants at risk
Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 \& 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 1: Combination Therapy Group B
n=22 participants at risk
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10\^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10\^7 (Cohort 5) or 10\^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Hormone Receptor Positive Breast Cancer (HRBC)
n=10 participants at risk
Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Triple Negative Breast Cancer (TNBC)
n=18 participants at risk
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Cutaneous Squamous Cell Carcinoma (CSCC)
n=10 participants at risk
Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Basal Cell Carcinoma (BCC)
n=5 participants at risk
Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Part 2: Colorectal Adenocarcinoma (CRC)
n=10 participants at risk
Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion.
Endocrine disorders
Hypothyroidism
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Eye disorders
Conjunctival haemorrhage
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Blood and lymphatic system disorders
Anaemia
30.4%
7/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
25.0%
6/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
13.6%
3/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
16.7%
3/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Cardiac disorders
Angina pectoris
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Cardiac disorders
Pericardial effusion
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Cardiac disorders
Sinus tachycardia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Cardiac disorders
Tachycardia
13.0%
3/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Ear and labyrinth disorders
Vertigo
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Endocrine disorders
Hyperthyroidism
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Abdominal discomfort
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
12.5%
3/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Abdominal pain upper
17.4%
4/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
25.0%
6/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Abnormal faeces
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Ascites
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
16.7%
4/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Constipation
21.7%
5/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
16.7%
4/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Diarrhoea
17.4%
4/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.8%
5/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
4/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Dry mouth
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Dysphagia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Gastritis
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Abdominal distension
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Abdominal pain
30.4%
7/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
25.0%
6/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
36.4%
8/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Oral candidiasis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Melaena
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Nausea
26.1%
6/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
58.3%
14/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
18.2%
4/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
70.0%
7/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
16.7%
3/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
4/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Gastrointestinal disorders
Vomiting
21.7%
5/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
33.3%
8/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
22.7%
5/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
50.0%
5/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
16.7%
3/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Application site pain
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Asthenia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.8%
5/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
27.8%
5/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Axillary pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Catheter site pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Chest pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Chills
17.4%
4/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
54.2%
13/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
36.4%
8/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
80.0%
8/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Facial pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Fatigue
47.8%
11/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
33.3%
8/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
18.2%
4/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
50.0%
5/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Influenza like illness
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
13.6%
3/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Injection site erythema
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Injection site haematoma
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Injection site haemorrhage
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Injection site pain
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
12.5%
3/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
18.2%
4/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
4/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Injection site paraesthesia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Injection site ulcer
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Malaise
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Non-cardiac chest pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Oedema
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Oedema peripheral
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
12.5%
3/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Pyrexia
78.3%
18/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
80.0%
4/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
91.7%
22/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
77.3%
17/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
90.0%
9/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
44.4%
8/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
90.0%
9/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Hepatomegaly
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Liver tenderness
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Portal vein stenosis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Immune system disorders
Contrast media allergy
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Immune system disorders
Immune-mediated adverse reaction
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
COVID-19
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Cellulitis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Diverticulitis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Herpes simplex viraemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Oral herpes
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Soft tissue infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Urinary tract infection
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Injury, poisoning and procedural complications
Fall
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Injury, poisoning and procedural complications
Infusion related reaction
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
13.6%
3/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Injury, poisoning and procedural complications
Injection related reaction
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Injury, poisoning and procedural complications
Post procedural diarrhoea
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Injury, poisoning and procedural complications
Procedural pain
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hyponatraemia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Injury, poisoning and procedural complications
Wound haemorrhage
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Alanine aminotransferase increased
17.4%
4/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
12.5%
3/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Aspartate aminotransferase increased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
25.0%
6/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Blood alkaline phosphatase increased
17.4%
4/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
12.5%
3/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Blood bilirubin increased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
12.5%
3/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
13.6%
3/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Blood creatinine abnormal
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Blood creatinine increased
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Blood potassium decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
C-reactive protein increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
CD4 lymphocyte percentage decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Creatinine renal clearance increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Ejection fraction decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Fibrin D dimer increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Gamma-glutamyltransferase increased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Haemoglobin decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Lymphocyte count abnormal
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Lymphocyte count decreased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Neutrophil count decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Platelet count decreased
13.0%
3/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
13.6%
3/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Serum ferritin decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Serum ferritin increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Thyroxine free decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Transaminases increased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Weight decreased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
Weight increased
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Investigations
White blood cell count decreased
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Decreased appetite
26.1%
6/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.8%
5/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Dehydration
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Folate deficiency
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Gout
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hyperkalaemia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypoalbuminaemia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypoglycaemia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypokalaemia
13.0%
3/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypomagnesaemia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Polydipsia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Metabolism and nutrition disorders
Type 1 diabetes mellitus
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Arthralgia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
18.2%
4/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Psychiatric disorders
Restlessness
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Back pain
17.4%
4/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.8%
5/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Renal and urinary disorders
Chromaturia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Fistula
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Limb discomfort
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Myalgia
17.4%
4/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Osteoporosis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Musculoskeletal and connective tissue disorders
Pain in extremity
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Renal and urinary disorders
Dysuria
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Renal and urinary disorders
Pollakiuria
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Dizziness
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Dysgeusia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Facial paralysis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Headache
26.1%
6/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
25.0%
6/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
4/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Hypergeusia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Lethargy
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Neurotoxicity
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Presyncope
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Psychiatric disorders
Anxiety
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Psychiatric disorders
Confusional state
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Psychiatric disorders
Insomnia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
12.5%
3/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
13.0%
3/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
60.0%
3/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
8.3%
2/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Hyperventilation
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
25.0%
6/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
27.3%
6/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Rash
8.7%
2/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
16.7%
4/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
30.0%
3/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
40.0%
2/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Skin and subcutaneous tissue disorders
Skin lesion
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Surgical and medical procedures
Mass excision
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Vascular disorders
Hypertension
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Vascular disorders
Hypotension
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
25.0%
6/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
9.1%
2/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
11.1%
2/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Vascular disorders
Lymphoedema
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.2%
1/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
General disorders
Peripheral swelling
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Hepatobiliary disorders
Hypertransaminasaemia
4.3%
1/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
4.5%
1/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
5.6%
1/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Campylobacter infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
1/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Gastroenteritis
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Upper respiratory tract infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Infections and infestations
Vaginal infection
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Injury, poisoning and procedural complications
Immunisation reaction
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
20.0%
2/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Nervous system disorders
Sciatica
0.00%
0/23 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/24 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/22 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/18 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
10.0%
1/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/5 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
0.00%
0/10 • From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

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