Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years

作者：Emily S. Ruiz, Eva Muñoz‐Couselo, Henri Montaudié, Miguel‐Ángel Berciano‐Guerrero, María del Carmen Álamo de la Gala, J. Charles, G. Quéreux, Charlée Nardin, Ricardo Yayá, Stéphane Dalle, Marie Beylot-Barry, Rahul Ladwa, Margaret McGrath, Daniel Brungs, Dean Harris, Hong Shue, Andrea Tazbirkova, Samuel Fourie, Daniel R Malan, James Oliviero, Lauren Neighbours Wilcoxen, Wm. Gray, Philip R. Clingan · 发表于：Journal of the American Academy of Dermatology · 年份：2025 · DOI：10.1016/j.jaad.2025.09.009 · 被引用次数：4 · 研究领域：Nonmelanoma Skin Cancer Studies、Polyomavirus and related diseases、Psoriasis: Treatment and Pathogenesis

BACKGROUND: Cosibelimab-ipdl, a high-affinity, programmed death-ligand 1-blocking antibody, is approved by the US Food and Drug Administration for treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation. OBJECTIVE: To report long-term efficacy and safety outcomes from a pivotal study of cosibelimab in mCSCC or laCSCC. METHODS: Patients received intravenous cosibelimab 800 mg every 2 weeks (mCSCC and laCSCC cohorts) or 1200 mg every 3 weeks (mCSCC cohort). The primary endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR) and safety. RESULTS: With a median follow-up duration of 29.3 months for the mCSCC cohort (n = 78), ORR was 50.0% (complete response [CR], 12.8%), median DOR was not reached, and estimated 24-month DOR was 72.1%. With a median follow-up duration of 24.1 months for the laCSCC cohort (n = 31), ORR was 54.8% (CR, 25.8%), median DOR was not reached, and the estimated 24-month DOR was 80.2%. Immune-related adverse event rate was 27.6%; 3.6% grade 3, no grade ≥4 events. LIMITATIONS: Nonrandomized; limited biomarker analysis. CONCLUSION: Cosibelimab demonstrated robust and durable ORRs with increasing CR rates in advanced CSCC and low rates of severe immune-related adverse events.