Sanofi and Regeneron Pharmaceuticals, said on Friday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma.
Sanofi and Regeneron previously reported positive, preliminary results for cemiplimab, an investigational human, monoclonal antibody targeting PD-1, from two expansion cohorts involving 26 advanced CSCC patients in a Phase 1 study of nearly 400 patients, at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2017.
EMPOWER-CSCC 1, a Phase 2, potentially pivotal, single-arm, open label clinical trial of cemiplimab is currently enrolling patients for metastatic CSCC and locally advanced and unresectable CSCC. Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement, Sanofi said. Pending data results, the companies expect submitting a biologics license application for cemiplimab with the FDA in the first quarter of 2018.
CSCC is the second most common type of skin cancer in the United States. Although CSCC has a good prognosis when caught early, it can prove especially difficult to treat when it progresses to advanced stages. Patients at this stage can be disfigured due to multiple surgeries to remove CSCC tumors on the head, neck and other parts of the body. CSCC is responsible for the most deaths among non-melanoma skin cancer patients.
Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.
Image: French multinational pharmaceutical company SANOFI logo is seen at the headquarters in Paris, France, March 8, 2016. REUTERS/Philippe Wojazer