Checkpoint Reports Positive Interim Efficacy Results From Trial Evaluating Cosibelimab

(RTTNews) - Checkpoint Therapeutics, Inc. (CKPT) reported positive interim efficacy results from its registration-enabling trial evaluating anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. As of the data cutoff, the objective response rate determined by independent central review in 31 patients was 54.8%, substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval of 25%.

Based on the positive results, the company plans to continue discussions with the FDA on the potential addition of locally advanced cutaneous squamous cell carcinoma as a second indication in the planned Biologics License Application targeted for submission later in the current year.