NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended Regeneron's Libtayo (cemiplimab) plus chemo for first-line treatment of advanced PD-L1-positive non-small cell lung cancer.
CHMP specifically recommended the combination for NSCLC patients who express PD-L1 in greater than or equal to 1 percent of tumor cells. It includes patients who don't have EGFR, ALK or ROS1 aberrations, who have metastatic or locally advanced tumors, and who are not candidates for definitive chemoradiation.
The CHMP recommendation was based on data from the Phase III EMPOWER-Lung 3 clinical trial. In that study, patients with PD-L1-positive tumors treated with Libtayo plus chemo had improved overall survival, 22 months versus 13 months on chemotherapy alone.
The submission will now be reviewed by the European Commission for a final decision on approval. Libtayo is already approved in Europe to treat locally advanced or metastatic cutaneous squamous cell carcinoma. In 2021, CHMP also recommended first-line Libtayo monotherapy for a similar patient population, advanced NSCLC patients with at least 50 percent of tumor cells expressing PD-L1. That recommendation was based on results from the earlier Phase III EMPOWER-Lung 1 trial.
In November, the US Food and Drug Administration approved the Libtayo-chemo combination as first-line treatment for advanced NSCLC patients who don't have EGFR, ALK, or ROS1 mutations regardless of PD-L1 expression. The drug is also approved in the US as a monotherapy first-line treatment for PD-L1-positive NSCLC patients who don't have EGFR, ALK, or ROS1 mutations.
Last year, Regeneron bought out Sanofi's stake in the companies' collaboration agreement for Libtayo, giving Regeneron worldwide development, commercialization, and manufacturing rights. The companies partnered on development and commercialization of Libtayo in 2015, with Sanofi obtaining ex-US rights.