Checkpoint Therapeutics announces publication of cosibelimab trial results

Checkpoint Therapeutics announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab, a differentiated and potential best-in-class anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma, in the Journal for ImmunoTherapy of Cancer, the peer-reviewed, online journal of the Society of Immunotherapy of Cancer. The paper, entitled, “Efficacy and Safety of Cosibelimab, an Anti-PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma”, describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries. Patients received cosibelimab 800 mg every two weeks as an intravenous infusion until disease progression or unacceptable toxicity. The study’s primary endpoint was objective response rate, ORR, assessed by independent central review using Response Evaluation Criteria in Solid Tumors, v.1.1. As of the pre-specified data cutoff date, the primary endpoint was met with highly clinically meaningful results. Median duration of response was not yet reached. The authors observed that cosibelimab treatment was associated with lower rates of severe immune-related adverse events as compared with those reported for similar studies of PD-1-targeting agents, concluding that cosibelimab may address an area of unmet clinical need for effective and better tolerated treatments for patients with metastatic cSCC who are ineligible for curative surgery or radiation. “Publication of these data expands the growing evidence supporting the efficacy and safety of cosibelimab,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We are encouraged by recently revealed longer-term data from our pivotal studies of cosibelimab, which demonstrate a deepening of response over time. We believe cosibelimab’s dual mechanism of action and potential favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients upon its potential launch early next year. We continue to work with the U.S. Food and Drug Administration toward the January 3, 2024, action date for our Biologics License Application for cosibelimab.”