Positive interim results from registration-enabling trial of cosibelimab in locally advanced cutaneous squamous cell carcinoma.

The design of the interim analysis incorporated recent feedback from the FDA and is intended to potentially support the approval of cosibelimab in this indication.

As of the March 2022 data cutoff, the objective response rate (ORR) determined by independent central review (ICR) in 31 patients was 54.8% (95% CI: 36.0, 72.7), substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval of 25%. Based on these positive results, Checkpoint intends to continue discussions with the FDA on the potential addition of locally advanced cSCC as a second indication in the planned Biologics License Application (BLA) targeted for submission later this year. Checkpoint previously reported positive top-line data from a cohort of 78 patients with metastatic cSCC in its pivotal trial of cosibelimab.

“These exciting positive interim results in this cohort of patients suggest a potential second indication for cosibelimab in locally advanced cSCC, which, when added to the potential labeling in the metastatic cSCC setting, could double the market opportunity at launch for cosibelimab globally. Locally advanced cSCC occurs when tumors become large or have grown deep into underlying tissues, muscles, or nerves, destroying nearby healthy tissue, but have not yet spread metastatically to the lymph nodes or other distant locations of the body," said James Oliviero, President and Chief Executive Officer of Checkpoint.

We believe the data generated to date continue to show cosibelimab as a differentiated and potentially best-in-class anti-PD-L1 antibody, leveraging a two-fold mechanism of action to deliver robust efficacy with a potentially more favorable safety profile due to its binding to PD-L1 rather than PD-1, an attribute reported in scientific literature as associated with lower rates of severe or worse adverse events as compared to anti-PD-1 therapy,” continued Oliviero. “Based on this compelling clinical profile, our planned market-disruptive pricing, and our patent protection through at least 2038, we believe cosibelimab has the opportunity to gain meaningful market share in the $32 billion and growing anti-PD-(L)1 class, while significantly lowering the barrier of high out-of-pocket costs patients endure worldwide to access existing premium-priced cancer therapies."