Trial Outcomes & Findings for A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer (NCT NCT04144517)

Last Updated: 2024-10-16

Results Overview

ORR was defined as percentage of participants with complete response (CR) or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

From the first dose of study drug until first PD or death, whichever occurred first (up to 49 weeks)

Results posted on

2024-10-16

Participant Flow

Participants took part in the study at 7 investigative sites in the United States.

This study consisted of Group 1 (Cohorts 1 and 2) and Group 2 (Cohorts 3 and 4). Group 1 was closed due to lack of recruitment of eligible participants and therefore, no data for Group 1 (Cohorts 1 and 2) were collected, analyzed or reported. Data was collected and analyzed for Group 2 and is presented in this results report.

Participant milestones

Participant milestones
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck (HNSCC) and with progressive disease (PD) with no prior response to greater than or equal to (\>=) 8 weeks anti programmed cell death ligand-1 (anti-PD-\[L\]1) therapy received nemvaleukin alfa 3 microgram per kilogram (mcg/kg), intravenous (IV) infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 milligram (mg), IV infusion, once, every three weeks (Q3W) on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response stable disease (SD) or partial response (PR) and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Overall Study STARTED	8	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck (HNSCC) and with progressive disease (PD) with no prior response to greater than or equal to (\>=) 8 weeks anti programmed cell death ligand-1 (anti-PD-\[L\]1) therapy received nemvaleukin alfa 3 microgram per kilogram (mcg/kg), intravenous (IV) infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 milligram (mg), IV infusion, once, every three weeks (Q3W) on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response stable disease (SD) or partial response (PR) and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Overall Study Physician Decision	0	1
Overall Study Other	2	2
Overall Study Death	6	3

Baseline Characteristics

A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Total n=14 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 15.19 • n=5 Participants	62.3 years STANDARD_DEVIATION 8.62 • n=7 Participants	62.3 years STANDARD_DEVIATION 12.36 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug until first PD or death, whichever occurred first (up to 49 weeks)

Population: Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline.

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Overall Response Rate (ORR) Based on RECIST v1.1	0 percentage of participants Upper and lower limit of 95% Confidence interval (CI) could not be estimated due to insufficient participants with events.	16.7 percentage of participants Interval 0.4 to 64.1

SECONDARY outcome

Timeframe: From first documented CR or PR until first documentation of PD (up to 49 weeks)

Population: Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline. Here, 'overall number of participants analyzed' signifies participants who had CR or PR.

DOR was defined as time in months from the first documentation CR or PR until the first documentation of confirmed PD as assessed by investigator based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=1 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Duration of Response (DOR) Based on RECIST v1.1	—	NA months Median and upper and lower limit of 95% CI could not be estimated due to insufficient participants with events.

SECONDARY outcome

Timeframe: From the first dose of study drug to date of PD, start of alternate therapy or death, whichever occurred first (up to 49 weeks)

Population: Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline.

PFS was defined as the time (in months) from the date of first dose of study drug to the date of first documentation of objective tumor progression, start of alternate therapy or death due to any cause, whichever occurred first, based on RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions.

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Progression-free Survival (PFS) Based on RECIST v1.1	1.3 months Interval 1.1 to 1.5	NA months Interval 1.2 to Median and upper limit of 95% CI could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From first dose of study drug to the date of the first documentation of PD (up to 49 weeks)

Population: Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline.

TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD based on RECIST 1.1. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the baseline SOD of target lesions.

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Time to Progression (TTP) Based on RECIST v1.1	1.3 months Interval 1.1 to 1.5	NA months Interval 1.2 to Median and upper limit of 95% CI could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From first dose of study drug until PD or death, whichever occurred first (up to 49 weeks)

Population: Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline.

DCR was defined as percentage participants with a confirmed CR, PR, or SD as assessed by an investigator based on RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study).

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Disease Control Rate (DCR) Based on RECIST v1.1	12.5 percentage of participants Interval 0.3 to 52.7	83.3 percentage of participants Interval 35.9 to 99.6

SECONDARY outcome

Timeframe: From date of first dose of study drug up to death from any cause (up to 89 weeks)

Population: Efficacy evaluable population included all participants who received at least one dose of both study drugs (nemvaleukin alfa or pembrolizumab) and had measurable disease at post-baseline.

OS was defined as the time from the date of the first dose of study drug until the date of death due to any cause. Participants were followed for survival after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Overall Survival (OS)	5.4 months Interval 1.8 to Upper limit of 95% CI could not be estimated due to insufficient events.	NA months Interval 3.9 to Median and upper limit of 95% CI could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks)

Population: Safety population included participants who received at least one dose of either study drug (nemvaleukin alfa or pembrolizumab).

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required participant's hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect. TEAE included AE that occurred or worsen after the first dose of study drug. The assessment of the relationship of study drug to TEAEs and SAEs was done by the Investigator (or designated sub-Investigator) according to their best clinical judgment.

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Number of Participants With Drug-related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Nemvaleukin Alfa Related TEAEs	6 Participants	4 Participants
Number of Participants With Drug-related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Pembrolizumab Related TEAEs	4 Participants	4 Participants
Number of Participants With Drug-related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Pembrolizumab Related SAEs	0 Participants	1 Participants
Number of Participants With Drug-related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Nemvaleukin Alfa Related SAEs	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks)

Population: Safety population included participants who received at least one dose of either study drug (nemvaleukin alfa or pembrolizumab).

An AE was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product. TEAE included AE that occurred or worsen after the first dose of study drug. The assessment of the relationship of study drug to AEs was done by the Investigator (or designated sub-Investigator) according to their best clinical judgment.

Outcome measures

Outcome measures
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 Participants Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 Participants Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Number of Participants With Drug-related TEAEs Leading to Discontinuation of Treatment Participants With Drug-related TEAEs Leading to Discontinuation of Nemvaleukin Alfa	3 Participants	0 Participants
Number of Participants With Drug-related TEAEs Leading to Discontinuation of Treatment Participants With Drug-related TEAEs Leading to Discontinuation of Pembrolizumab	3 Participants	0 Participants

Adverse Events

Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 6 deaths

Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Group 2, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=8 participants at risk Participants with advanced, recurrent and/or metastatic squamous cell carcinoma of the HNSCC and with PD with no prior response to \>=8 weeks anti-PD-(L)1) therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.	Group 2, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg n=6 participants at risk Participants with advanced, recurrent and/or metastatic HNSCC and with current PD after prior achievement of best response SD or PR and after \>=8 on weeks on anti-PD-(L)1 therapy received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.
Infections and infestations Pneumonia	0.00% 0/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	16.7% 1/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Infections and infestations Skin infection	12.5% 1/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Infections and infestations Wound infection	12.5% 1/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Metabolism and nutrition disorders Hypercalcaemia	12.5% 1/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Metabolism and nutrition disorders Hypokalaemia	12.5% 1/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Metabolism and nutrition disorders Hyponatraemia	12.5% 1/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Nervous system disorders Syncope	25.0% 2/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	12.5% 1/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	16.7% 1/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
General disorders Pyrexia	0.00% 0/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	16.7% 1/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.
Musculoskeletal and connective tissue disorders Muscular weakness	12.5% 1/8 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.	0.00% 0/6 • Serious and Other (non-serious) AEs: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks); Mortality: From first dose of study drug up to 89 weeks An AE is any untoward medical occurrence in a participant or clinical investigation participant who has been administered a pharmaceutical product. The occurrence, which may or may not have a causal relationship with the investigational treatment, may include any clinical or laboratory change that does not commonly occur in that patient and is considered clinically significant.

Other adverse events

Additional Information

Study Director

Mural Oncology, Inc.

Phone: +1 (781) 614-0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER