On March 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the PD-1 inhibitor retifanlimab-dlwr (Zynyz) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
Safety and efficacy were evaluated in PODIUM-201, an open-label, multiregional, single-arm study evaluating 65 patients with metastatic or recurrent locally advanced Merkel cell carcinoma who had not received prior systemic therapy for advanced disease. The major efficacy outcome measures were objective response rate and duration of response assessed by an independent central review committee according to Response Evaluation Criteria in Solid Tumors version 1.1. The objective response rate was 52%, with a complete response rate of 18%. Twenty-six patients (76%) had a duration of response lasting at least 6 months, and 21 (62%) had a duration of response of 12 months or more.