Sanofi and Regeneron Pharmaceuticals have been given conditional approval by the European Commission (EC) for their fully-human monoclonal antibody Libtayo (cemiplimab) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults.
The European approval for Libtayo is for such patients who are not eligible for curative surgery or curative radiation.
The skin cancer drug was given the regulatory nod based on the findings of the EMPOWER-CSCC-1 (Study 1540) trial, which is an open-label, non-randomized phase 2 study. Its approval was also backed by two advanced CSCC expansion cohorts from an open-label, non-randomized phase 1 trial (Study 1423).
University Hospital Schleswig-Holstein interdisciplinary skin cancer centre head Axel Hauschild, who was an investigator in the pivotal CSCC clinical program, said: “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.
“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.”
A new patient group will be added to the EMPOWER-CSCC-1 trial by Sanofi and Regeneron to further demonstrate the benefit-risk profile of Libtayo, and report the emerging data to the European Medicines Agency (EMA).
According to Sanofi, Libtayo’s recommended dose is 350mg every three weeks with the drug to be intravenously infused over 30 minutes. The company said that treatment can be continued until disease progression or unacceptable toxicity.
Designed to target the programmed cell death protein-1 (PD-1) immune checkpoint receptor, the monoclonal antibody is being jointly developed under a global collaboration agreement by Sanofi and Regeneron. The drug was invented by Regeneron using its VelocImmune technology, which is said to generate optimised fully-human antibodies.
In late 2018, Libtayo (cemiplimab-rwlc) was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
The monoclonal antibody is also approved in Canada and Brazil for the same indication.