Posted by Michael Wonder on 03 Apr 2018
EMA to review cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
3 April 2018 - The EMA has accepted for review the marketing authorisation application for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced cutaneous squamous cell carcinoma who are not candidates for surgery.
Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1).
The application for cemiplimab 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 Annual Meeting. Updated results from both clinical trials are being submitted for presentation at upcoming medical congresses.
