Libtayo has been approved in Europe 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 (cemiplimab) 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 EU.
The approval from the European Commission is based on data from the pivotal, open-label, multi-centre, non-randomised Phase 2 trial known as EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-centre, 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.
“With no other medical treatments approved for advanced CSCC in the EU, Libtayo represents an important new option for patients affected with this advanced skin cancer who cannot be cured by surgery or radiation,” said Axel Hauschild, an investigator in the pivotal CSCC clinical program and Professor and Head of the Interdisciplinary Skin Cancer Centre at the University Hospital Schleswig-Holstein in Kiel, Germany.
“Results from the Libtayo pivotal trial are very encouraging and demonstrated substantial and durable responses following Libtayo treatment, including in the elderly and regardless of PD-L1 expression levels.”
Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.