Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nemvaleukin Alfa · 2 trials · 2 indications
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.
Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies
| Arm | Type | Description |
|---|---|---|
| Group 1: Nemvaleukin 3 mcg/kg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants with current stable disease (SD) or partial response (PR) (Cohorts 1 and 2) who were not progressing or further demonstrating reductions in tumor size were to receive 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: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants with progressive disease (PD) (Cohorts 3 and 4) 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. |
| Cohort 1: Tumor Microenvironment (TME) Nemvaleukin and Pembrolizumab | EXPERIMENTAL | Nemvaleukin will be administered via Intravenous (IV) infusion given daily for 5 consecutive days followed by an off-treatment period. Starting on Cycle 3, Day 1 of each cycle, Pembrolizumab will be administered via IV infusion followed by IV infusion of nemvaleukin |
| Cohort 2 Part A: Less Frequent IV Dosing Nemvaleukin | EXPERIMENTAL | - |
| Cohort 2 Part B: Less Frequent IV Dosing Nemvaleukin and Pembrolizumab | EXPERIMENTAL | This arm will not open for enrollment. |
| Name | Type | Description |
|---|---|---|
| Nemvaleukin Alfa | DRUG | Nemvaleukin alfa IV infusion. |
| Pembrolizumab | DRUG | Pembrolizumab IV infusion. |
Inclusion Criteria: * Patients must have histologically or cytopathologically confirmed diagnosis of non-cutaneous squamous cell carcinoma of the head and neck region that is locally advanced and/or recurrent and no longer amenable to local surgical or radiation therapy and/or with evidence of dist...
Nemvaleukin Alfa is an investigational oncology therapy being studied for squamous cell carcinoma of the head and neck and advanced solid tumors. It is currently in Phase 2 clinical development for these indications. The drug is being evaluated both as a monotherapy and in combination with pembrolizumab in clinical trials.
Nemvaleukin Alfa is being developed by Mural Oncology plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol MURA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
Nemvaleukin Alfa is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating squamous cell carcinoma of the head and neck and advanced solid tumors.
Nemvaleukin Alfa is being studied in two clinical trials. NCT04144517 is a Phase 2 study of the drug with pembrolizumab in head and neck cancer, which has been completed. NCT04592653 is a Phase 1 study of less frequent intravenous dosing and tumor microenvironment effects, both as monotherapy and with pembrolizumab, in advanced solid tumors.
Yes, Nemvaleukin Alfa is being evaluated in combination with pembrolizumab in clinical trials. One completed Phase 2 study (NCT04144517) tested this combination in squamous cell carcinoma of the head and neck, and an ongoing Phase 1 study (NCT04592653) is also assessing the combination in advanced solid tumors.
One Nemvaleukin Alfa trial, NCT04144517, a Phase 2 study in head and neck cancer, has been completed. Another trial, NCT04592653, a Phase 1 study in advanced solid tumors, is active but not recruiting participants. Both trials are being conducted in the United States, with the Phase 1 study also including sites in Spain.