Sanofi has announced the European approval of its fully-human monoclonal antibody, Libtayo (cemiplimab), for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma.
The European Commission has granted conditional marketing authorisation for the drug for patients who are not candidates for curative surgery or curative radiation.
The fully-human monoclonal antibody targets 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 is based on data from the pivotal, open-label, multi-center, non-randomised Phase II trial known as EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-centre, open-label, non-randomised Phase I trial (Study 1423).
“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, investigator in the pivotal CSCC clinical program and head of the Interdisciplinary Skin Cancer Center at the University Hospital Schleswig-Holstein in Kiel, Germany.
He continued, “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.”
In addition to the EU, Libtayo is also approved in the U.S., Canada and Brazil for this indication. It is currently also being investigated in adjuvant and neoadjuvant trials in CSCC and in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer.
CSCC is one of the most common skin cancers worldwide and is especially difficult to treat in advanced stages.
