Summary

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• Zynyz (retifanlimab-dlwr) is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• The Overall Response Rate (ORR) was 13.8% (95% CI: 7.6% to 22.5%), including 1 complete response (1.1%) and 12 partial responses (12.8%) in patients with advanced or metastatic squamous carcinoma of the anal canal (SCAC) who had progressed after platinum-based chemotherapy.
• The Disease Control Rate (DCR) was 48.9% (95% CI: 38.5% to 59.5%), with 35.1% of patients (33 individuals) showing stable disease.
• The Progression-Free Survival (PFS) and Overall Survival (OS) medians were 2.3 months (95% CI: 1.9-3.6 months) and 10.1 months (95% CI: 7.9-not estimable), respectively, with a median Duration of Response (DOR) of 9.5 months (range: 5.6 months-not estimable).
• The safety profile of Retifanlimab in this study was described as consistent with previous experience for the PD-(L)1 inhibitor class, with no specific safety outcomes or adverse effects detailed in the study.
• The study does not highlight any new or significant safety concerns or adverse effects specific to this population.
• Responses to Retifanlimab were observed across all subgroups, with no significant differences noted based on HIV/HPV status, PD-L1 expression levels, or the presence of liver metastases.