Checkpoint Therapeutics Inc (NASDAQ:CKPT) announced topline results from its registration-enabling clinical trial evaluating cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cutaneous squamous cell carcinoma (cSCC).
- The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate (ORR) of 47.4%.
- The median duration of response (DOR) had not yet been reached at the data cut-off point (76% of responses are ongoing).
- Safety data across 201 patients with advanced cancers enrolled and treated in all cohorts of the ongoing study remain consistent with those previously reported, with the majority of treatment-emergent adverse events reported as Grade 1 or 2 in severity.
- Checkpoint intends to submit a Biologics License Application to the FDA for cosibelimab later this year, followed by a marketing authorization application submission in Europe and additional potential submissions in markets worldwide.
- Additionally, Checkpoint continues to enroll a registration-enabling cohort of patients with locally advanced cSCC, anticipating this potential second indication could be included in the planned initial BLA submission and global Phase 3 CONTERNO trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer.
- Price Action: CKPT shares are up 11.0% at $2.43 during the market session on the last check Tuesday.
