European Commission approves Libtayo to treat advanced cutaneous squamous cell carcinoma

The European Commission (EC) has granted conditional marketing authorization for Libtayo (cemiplimab) from Regeneron + Sanofi for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved in advanced CSCC in the European Union (EU). Updated data from the registrational EMPOWER-CSCC-1 trial were recently shared at the 2019 American Society of Clinical Oncology Annual Meeting .

CSCC is one of the most commonly diagnosed skin cancers worldwide, and its incidence is estimated to be substantially increasing in some European countries. Although the vast majority of patients with CSCC have a good prognosis when discovered early, the cancer can be especially difficult to treat when it progresses to advanced stages.Advanced CSCC includes both patients with locally advanced disease (where the cancer cannot be cured by surgery and/or radiation) and patients with metastatic disease (when the cancer spreads to other parts of the body). Based upon historical data, patients with advanced CSCC have a life expectancy of approximately one year.

The EC approval is based on data from the pivotal, open-label, multi-center, non-randomized Phase II trial known as EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized Phase 1 trial (Study 1423). These trials provide the largest prospective clinical data set evaluating a systemic therapy in patients with advanced CSCC to date. The recommended dose of Libtayo is 350 mg every 3 weeks administered by intravenous infusion over 30 minutes. Treatment may be continued until disease progression or unacceptable toxicity.

The conditional approval recognizes the extreme unmet need in advanced CSCC. As part of the conditional approval, Sanofi and Regeneron will add a new patient group to EMPOWER-CSCC-1 to further support the benefit-risk profile of Libtayo, and report the results to the European Medicines Agency (EMA). As is standard practice for conditional approvals, the EMA reviews new information at least every year and updates product labeling as necessary.