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The primary report of the metastatic cohort of CK-301-101: cosibelimab shrank tumours in 37 of 78 patients, most responses were still going at the cut-off, and severe immune side effects were uncommon.
Pivotal metastatic cutaneous squamous cell carcinoma cohort of an open-label, multicentre, multiregional, multicohort phase 1 trial of cosibelimab, a PD-L1-blocking IgG1 antibody with a functional Fc domain. Participants received cosibelimab 800 mg intravenously every 2 weeks. The primary endpoint was objective response rate by independent central review using RECIST 1.1; secondary endpoints were duration of response and safety.
Objective response was observed in 37 of 78 participants (47.4 percent, 95% CI 36.0 to 59.1) at a median follow-up of 15.4 months. Median duration of response was not reached (range 1.4+ to 34.1+ months), with response ongoing in 73.0 percent of responders. Immune-related adverse events occurred in 18 participants (23.1 percent), grade 3 in 2 (2.6 percent), with no grade 4 or 5 events and no treatment-related deaths.
This cohort, with the locally advanced cohort in the label, is the evidence behind cosibelimab's December 2024 US approval. The response rate is of the same order as cemiplimab and pembrolizumab in this cancer, which gives patients a third checkpoint antibody option, though none of the three has been compared head to head.
Shares Checkpoint Therapeutics, Cosibelimab.
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares Cosibelimab, PD-L1.
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.