EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

On April 3, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) 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. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor programmed cell death protein 1 (PD-1).

The MAA for cemiplimab is based on a phase II, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1), in addition to phase I 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 I expansion cohort results were presented at the 2017 ASCO Annual Meeting (Abstract 9503). Updated results from both clinical trials are being submitted for presentation at upcoming medical congresses.

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

About CSCC

CSCC is one of the most common cancers worldwide, 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 nonmelanoma skin cancer.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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