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Cancer research

Retifanlimab Shows Promising Results in Treating Merkel Cell Cancer

Strategic Insights

— 1 min read

Research presented in a Phase II clinical trial has demonstrated that retifanlimab, a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1), can induce frequent and durable responses in chemotherapy-naive patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). The study, known as POD1UM-201, enrolled 101 patients across 34 sites in the USA, Canada, and Europe, and evaluated the efficacy and tolerability of retifanlimab.

Key Takeaways:

  • The primary endpoint of the study was objective response rate (ORR), which was achieved by 54.5% of patients, with 18 patients (17.8%) experiencing complete responses (CRs) and 37 (36.6%) experiencing partial responses (PRs).
  • The disease control rate (DCR) was 60.4%, with a median duration of follow-up for response of 22.2 months.
  • The estimated median progression-free survival (PFS) was 16.0 months, and the estimated median overall survival (OS) was not reached, with 63% of patients alive at 3 years.
  • The safety profile of retifanlimab was representative of the PD-1 inhibitor class, with grade 3 immune-related adverse events occurring in 11 patients (10.9%).
  • The study demonstrates that retifanlimab represents a new immunotherapy option for patients with locally advanced or metastatic MCC.

Statistics:

  • ORR: 54.5% (95% CI: 44.2% to 64.4%; n=55)
  • Complete responses (CRs): 17.8% (n=18)
  • Partial responses (PRs): 36.6% (n=37)
  • Disease control rate (DCR): 60.4% (95% CI: 50.2% to 70.0%; n=61)
  • Estimated median PFS: 16.0 months (95% CI: 9.0 months to 32.2)
  • Estimated median OS: not reached
  • Patients alive at 3 years: 63%

Sources:

  • NewsRx. Investigators at Candiolo Cancer Institute Zero in on Merkel Cell Cancer [Phase II study of retifanlimab in patients with recurrent locally advanced or metastatic Merkel cell carcinoma (POD1UM-201)]. Immunotherapy Weekly. August 27, 2025; p 1583.
  • Journal for ImmunoTherapy of Cancer, 2025;13(8). Journal for ImmunoTherapy of Cancer can be contacted at: Bmj Publishing Group, British Med Assoc House, Tavistock Square, London WC1H 9JR, England.

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