On April 30, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery (Press release, Regeneron, APR 30, 2018, View Source [SID1234525830]). Advanced CSCC is the deadliest non-melanoma skin cancer. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1) and was granted Breakthrough Therapy designation status by the FDA in September 2017. The target action date for the FDA decision is October 28, 2018.
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The BLA submission is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to Phase 1 data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery. Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 expansion cohort results were presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Updated results from both clinical trials will be presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting.
In the European Union, the European Medicines Agency accepted for review in April 2018 the Marketing Authorization Application for cemiplimab in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.
Cemiplimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement and was invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully-human antibodies.
Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.
About CSCC
Cutaneous squamous cell carcinoma (CSCC) is the second most common type of skin cancer in the U.S., with the number of newly diagnosed cases expected to rise annually. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for approximately 7,000 deaths in the U.S. each year. There are currently no FDA-approved treatments for advanced CSCC.