Checkpoint' Cancer Therapy Shows Almost 55% Response Rate In Skin Cancer Patients

Checkpoint Therapeutics Inc CKPT announced positive interim efficacy results from its registration-enabling trial of 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 FDA feedback and is intended to support the approval of cosibelimab in this indication potentially.
As of the March 2022 data cutoff, the objective response rate (ORR) in 31 patients was 54.8%, substantially exceeding a clinically meaningful lower bound of 25%.
Checkpoint intends to continue discussions with the FDA on potentially adding locally advanced cSCC as a second indication in the planned marketing application 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.
Related: Checkpoint Therapeutics' Cosibelimab Posts 47.4% ORR In Skin Cancer Patients.
Checkpoint licensed Cosibelimab in 2015 from the Dana-Farber Cancer Institute.
Price Action: CKPT shares are down 1.85% at $1.06 during the premarket session on the last check Thursday.