- Checkpoint Therapeutics Inc (NASDAQ: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.
