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Sanofi and Regeneron’s Cemiplimab Receives FDA "Breakthrough Designation"

Sanofi and Regeneron announced that Cemiplimab (REGN2810) has received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma.

Cemiplimab is an investigational human, monoclonal antibody targeting PD-1. It would be used to treat adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma.

Preliminary results for Cemiplimab from two expansion cohorts involving 26 advanced CSCC patients in a Phase 1 study of nearly 400 patients have been reported positive.

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.

Patients treated with Cemiplimab demonstrated an overall response rate of 46.2% including two complete responses, nine partial responses and one unconfirmed partial response and a disease control rate of 69.2%.s

CSCC is the second most common type of skin cancer in the United States. It is difficult to treat when it reaches to advanced stages, although CSCC has a good prognosis when caught early.

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.

Patients treated with Cemiplimab demonstrated an overall response rate of 46.2% including two complete responses, nine partial responses and one unconfirmed partial response and a disease control rate of 69.2%.

Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.

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