Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and locally advanced and unresectable CSCC.
In a previous Phase 1 study evaluating nearly 400 patients, cemiplimab demonstrated positive data from two expansion cohorts that included 26 advanced CSCC patients. Treatment with cemiplimab led to an overall response rate (ORR) of 46.2% and a disease control rate of 69.2%. The median progression-free survival and overall survival were not reached at the time of data cutoff.
A Phase 2, single-arm, open-label clinical trial, EMPOWER-CSCC 1, is now enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC.
Cemiplimab, a human monoclonal antibody targeting PD-L1, utilizes VelocImmune technology which produces optimized fully-human antibodies. The Companies plan to submit a Biologics License Application (BLA) for cemiplimab in the first quarter of 2018 pending study results.
The FDA’s Breakthrough Therapy designation includes the Fast Track program features along with a more comprehensive FDA guidance and discussion.