TriangleHEALTH PROFESSIONAL · SOURCE READING
Retifanlimab
Source: Merkel Cell Carcinoma Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 9, 2025 · Captured 2026-09-09.
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Context: Treatment Option Overview for Merkel Cell Carcinoma / Immunotherapy
Retifanlimab is an anti–PD-1 monoclonal antibody.
Evidence (retifanlimab):
Retifanlimab was evaluated in a phase II trial (POD1UM-201 [NCT03599713]), published in abstract form, of 101 patients with previously untreated advanced MCC. Patients received 500mg intravenously (IV) every 4 weeks.[42,43] Based on the results of this trial, the FDA granted accelerated approval to retifanlimab in 2023.
Source links and citations
Retifanlimab was evaluated in a phase II trial (POD1UM-201 [NCT03599713]), published in abstract form, of 101 patients with previously untreated advanced MCC. Patients received 500mg intravenously (IV) every 4 weeks.[42,43] Based on the results of this trial, the FDA granted accelerated approval to retifanlimab in 2023.
Preliminary results after a median follow up 17.6 months demonstrated a complete response rate of 16.8%, a partial response rate of 38.6%, and an overall response rate of 53.5% (95% CI, 43.3%–63.5%).[42,43][Level of evidence C3]
Source links and citations
Retifanlimab was evaluated in a phase II trial (POD1UM-201 [NCT03599713]), published in abstract form, of 101 patients with previously untreated advanced MCC. Patients received 500mg intravenously (IV) every 4 weeks.[42,43] Based on the results of this trial, the FDA granted accelerated approval to retifanlimab in 2023.
The median PFS was 12.7 months (95% CI, 7.3–24.9) and the median duration of response was 25.3 months (95% CI, 14.2–not estimable). The median OS was not yet reached.
Studies cited in this source section
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Preserved source evidence · Not medical advice