The US
Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease. The FDA granted the application for retifanlimab
priority review,
fast track, and
orphan drug designations. The efficacy of retifanlimab with carboplatin and paclitaxel was evaluated in POD1UM-303/InterAACT 2 (NCT04472429), a randomized, multi-center, double-blind trial in 308 participants with chemotherapy-naïve inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal. Participants received carboplatin AUC of 5 on day 1, and paclitaxel 80 mg/m on days 1, 8, and 15 for 6 cycles and were randomized (1:1) to receive either retifanlimab 500 mg intravenously every 4 weeks; or placebo intravenously every 4 weeks. The efficacy of retifanlimab as a single agent was evaluated in POD1UM-202 (NCT03597295), an open-label, multi-center, single-arm trial in 94 participants with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Participants received retifanlimab 500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months. == Society and culture ==