Checkpoint Therapeutics releases positive interim results for cosibelimab

US biotech Checkpoint Therapeutics (Nasdaq: CKPT) today announced positive interim efficacy results from its registration-enabling clinical trial evaluating its anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation.

The design of the interim analysis incorporated recent feedback from the US Food and Drug Administration (FDA) and is intended to potentially support the approval of cosibelimab in this indication. As of the March 2022 data cut-off, 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.