Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma

Excerpt from the Press Release:

• Study met primary endpoint with 47.4% objective response rate
• Safety and tolerability profile consistent with previously reported data
• Planned BLA submission on track for later this year
• Conference call to be held today, Tuesday, January 25, 2022, at 8:30 AM ET

WALTHAM, Mass., Jan. 25, 2022 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, 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% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 (“RECIST 1.1”) criteria. 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. Based on these results, Checkpoint intends to submit a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration for cosibelimab later this year, to be followed by a marketing authorization application (“MAA”) submission in Europe and additional potential submissions in markets worldwide.

“Most people don’t realize that cutaneous squamous cell carcinoma is the second most common form of skin cancer. While treatable with surgery when caught early, cSCC patients diagnosed with advanced disease that has recurred or metastasized have traditionally faced a poor prognosis and often suffer from painful physical discomfort,” commented Professor Philip Clingan, Medical Oncologist at Southern Medical Day Care Centre in Australia and co-principal investigator of the trial. “These impressive results demonstrate that cosibelimab, a novel PD-L1 antibody with a unique two-fold mechanism of action, has the potential to offer physicians a new treatment option that provides compelling efficacy, complemented by a favorable tolerability profile, for patients living with this devastating disease.”

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