Checkpoint Therapeutics Presents Cosibelimab Longer-Term Results In Advanced CSCC

(RTTNews) - Checkpoint Therapeutics, Inc. (CKPT), a clinical-stage immunotherapy and targeted oncology company, announced Monday longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 or PD-L1 antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma or cSCC.

The Biologics License Application or BLA of cosibelimab is currently under review by the U.S. Food and Drug Administration. Prescription Drug User Fee Act or PDUFA goal date is December 28, 2024.

If approved by the FDA, cosibelimab's dual mechanisms of action and safety profile may position the product, over time, as the preferred immunotherapy of U.S. oncologists, the company noted.

The longer-term efficacy and safety results are being presented during the European Society for Medical Oncology or ESMO Congress 2024, which is taking place in Barcelona, Spain, from September 13 to 17.

In the trial, with 16 months of additional follow-up since the primary analysis, cosibelimab demonstrated increasing objective response rates or ORRs and complete response rates per independent central review in 109 patients with advanced cSCC.

Overall, in 192 advanced cSCC patients treated with cosibelimab, a manageable safety profile was observed, with notable low rates of treatment-emergent adverse events or TEAEs, severe immune-related adverse events or irAEs, and treatment discontinuations.

In December 2023, the FDA issued a complete response letter for the cosibelimab BLA for the treatment of patients with metastatic or locally advanced cSCC who are not candidates or curative surgery or radiation.

In July 2024, Checkpoint announced it had completed a resubmission of the BLA to the FDA for cosibelimab to potentially address the approvability issues cited in the CRL.

The resubmission was accepted by the FDA as a complete response and the FDA has set a PDUFA goal date of December 28, 2024.

James Oliviero, President and Chief Executive Officer of Checkpoint, said, "These longer-term results for cosibelimab presented at the ESMO Congress demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses, and continue to expand the evidence supporting the efficacy and safety of cosibelimab as a potential new treatment for advanced cSCC."

In pre-market activity on the Nasdaq, Checkpoint shares were gaining around 2.2 percent to trade at $2.35.

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