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

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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. In this pivotal phase 1 study of cosibelimab in mCSCC or laCSCC (ClinicalTrials.gov identifier: NCT03212404), we report long-term efficacy and safety outcomes. 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. 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 estimated 24-month DOR was 80.2%. Immune-related adverse event (irAE) rate was 27.6%; 3.6% grade 3, no grade ≥4 events. In this pivotal study of patients with mCSCC and laCSCC, cosibelimab was associated with robust and clinically meaningful ORRs ≥50% and CR rates, durable DORs, and a manageable safety profile with low rates of grade 3 irAEs and no grade ≥4 irAEs. These results provide additional support for the use of cosibelimab in patients with mCSCC and laCSCC.

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