SITC 2019: Adding IL-2 Agonist to Nivolumab in Metastatic Melanoma
Posted: Friday, November 22, 2019
In the phase I/II PIVOT-2 trial, clinical activity as well as durable responses were reported with the combination treatment of the CD-122 preferential inerleukein-2 (IL-2) agonist bempegaldesleukin plus the PD-1 inhibitor nivolumab in the first-line treatment of metastatic melanoma. Based on these early study findings, the U.S. Food and Drug Administration granted this regimen Breakthrough Therapy designation. Adi Diab, MD, of MD Anderson Cancer Center, Houston, and colleagues presented this work at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, Maryland (Abstract O35).
A total of 41 patients with previously untreated stage IV metastatic melanoma were enrolled in this study. Patients were given one or more doses of 0.006 mg/kg of bempegaldesleukin plus 360 mg of nivolumab every 3 weeks. The response rate was assessed every 3 weeks.
After a median follow-up of 12.7 months, 38 of the 41 patients were able to be evaluated. The overall response rate (complete response plus partial response) was 53% (20 patients), and a complete response was achieved in 13 patients. Approximately 42% of patients had a 100% reduction in target lesions after treatment. The median time to response was 2 months, and the median time to complete response was 7 months. The median duration of response was not yet reached.
This combination treatment was generally well tolerated, according to the investigators. Treatment-related adverse events were similar to what had previously been reported, with 14.6% of patients experiencing a grade 3 or higher adverse event and 9.8% of patients discontinuing treatment due to adverse events.
Disclosure: For full disclosures of other study authors, visit sitcancer.org.