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European Commission Approves Regeneron, Sanofi's Libtayo for First-Line NSCLC

NEW YORK – Regeneron Pharmaceuticals and Sanofi announced on Friday that the European Commission has approved their PD-1 inhibitor Libtayo (cemiplimab) as a first-line option for advanced non-small cell lung cancer patients with PD-L1 expression in at least 50 percent of tumor cells and no EGFR, ALK, or ROS1 alterations.

In order to receive the immunotherapy, NSCLC patients with metastatic or locally advanced tumors cannot be candidates for chemoradiation.

The EC approved the latest indication based on results from the Phase III EMPOWER-Lung 1 trial, in which around 700 NSCLC patients received the PD-1 inhibitor or platinum-doublet chemotherapy. Patients were tested for PD-L1 expression by Agilent Technologies/Dako's PD-L1 IHC 22C3 PharmDx kit and could not have alterations in EGFR, ALK or ROS1 to partake in the study.

In the prespecified population of those with PD-L1 tumor expression of 50 percent or more, cemiplimab reduced the risk of death by 43 percent for patients. Median overall survival was not reached in the cemiplimab arm and 14 months in the chemotherapy arm. In the overall study population, cemiplimab reduced the risk of death by 32 percent and extended median overall survival by eight months compared to chemotherapy, despite three-fourths of the patients in the chemo arm crossing over to the cemiplimab arm.

The US Food and Drug Administration in February also approved cemiplimab for first-line, PD-L1-high, advanced NSCLC, along with the PD-L1 IHC 22C3 PharmDx companion test to identify the biomarker-eligible population.

In addition to the first-line advanced NSCLC indication, the EC on Friday also approved cemiplimab for certain advanced basal cell cancer patients. In 2019 it had approved the drug for advanced cutaneous squamous cell cancer patients.