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Published on: February 24, 2023
Interleukin-21 has activity in patients with metastatic melanoma: a phase II study
Teresa M Petrella1, Richard Tozer, Karl Belanger
1Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada M4N 3M5. teresa.petrella@sunnybrook.ca
Purpose:
We report a multicenter phase II study of patients with metastatic melanoma (MM), evaluating the efficacy, toxicity, progression-free survival (PFS), immunogenicity, and biomarker profile of interleukin-21 (IL-21).
Patients And Methods:
Patients with no prior systemic therapy and with limited-disease MM were treated with IL-21 by using three different dosing regimens. Cohort 1 received 50 μg/kg per day by outpatient intravenous bolus injection for 5 days of each week during weeks 1, 3, and 5 of an 8-week cycle. Cohort 2 received 30 μg/kg per day on the same schedule, and cohort 3 received 50 μg/kg per day for 5 days of each week during weeks 1 and 3 of a 6-week cycle.
Results:
Forty patients were enrolled: three in cohort 1, 30 in cohort 2, and seven in cohort 3. Two patients in cohort 1 and four in cohort 3 had dose-limiting toxicities; all other patients were treated with a dose of 30 μg/kg per day. Common adverse events were fatigue, rash, diarrhea, nausea, and myalgia. Overall response rate (ORR) was 22.5%, with nine confirmed partial responses (median response duration, 5.3 months); 16 had stable disease (median response duration, 5.3 months). ORR did not appear to depended on IL-21 receptor expression or BRAF mutation status. The median PFS was 4.3 months and median overall survival (OS) was 12.4 months (95% CI, 10.09 to 17.81 months).
Conclusion:
The ORR to IL-21 is 22.5% for first-line MM and warrants further investigation. The favorable PFS and OS suggest that this is an active agent in comparison to both historical NCIC Clinical Trials Group data and data from meta-analysis of Cooperative Group phase II trials.
Insights
Interleukin-21 (IL-21) showed a 22.5% overall response rate in metastatic melanoma patients. This immunotherapy demonstrated favorable progression-free survival and overall survival, warranting further investigation.
Area of Science:
- Oncology
- Immunotherapy
- Melanoma Research
Background:
- Metastatic melanoma (MM) remains a significant challenge in cancer treatment.
- Interleukin-21 (IL-21) is an immunomodulatory cytokine with potential anti-cancer activity.
- Evaluating novel therapeutic agents for advanced melanoma is crucial.
Purpose of the Study:
- To assess the efficacy and safety of interleukin-21 (IL-21) in patients with metastatic melanoma (MM).
- To determine progression-free survival (PFS), overall survival (OS), immunogenicity, and biomarker profiles associated with IL-21 treatment.
- To explore different dosing regimens of IL-21 in a multicenter phase II study.
Main Methods:
- A multicenter phase II study involving 40 patients with treatment-naive, limited-disease MM.
- Patients received IL-21 via intravenous bolus injection in three different dosing regimens.
- Adverse events, overall response rate (ORR), PFS, and OS were meticulously monitored.
Main Results:
- The overall response rate (ORR) to IL-21 was 22.5%, with a median PFS of 4.3 months and median OS of 12.4 months.
- Common adverse events included fatigue, rash, diarrhea, nausea, and myalgia.
- Response did not appear to correlate with IL-21 receptor expression or BRAF mutation status.
Conclusions:
- Interleukin-21 (IL-21) demonstrates a 22.5% ORR in first-line metastatic melanoma (MM), indicating its potential as an active agent.
- The observed favorable PFS and OS support further investigation of IL-21 in MM treatment.
- IL-21 shows promise as a therapeutic option for metastatic melanoma, comparable to existing trial data.
