Dr. Christine Chung and Dr. Nikhil Khushalani were part of a multi-site, phase 1 study published in The New England Journal of Medicine. Results showed the efficacy of cemiplimab for the treatment of advanced cutaneous squamous cell cancer (CSCC). Advanced CSCC is the deadliest non-melanoma skin cancer.
Approximately half the patients with advanced CSCC showed response to cemiplimab and this treatment was associated with similar adverse events experienced with other immune checkpoint inhibitors.
Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed death 1).
The U.S. Food and Drug Administration (FDA) has accepted cemiplimab for priority review for the treatment of patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery. The target action date for the FDA decision is October 28, 2018. Cemiplimab was previously granted breakthrough therapy designation status by the FDA in September 2017.
The FDA 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. Updated results from both clinical trials were presented at the 2018 ASCO Annual Meeting.