Posted: Friday, January 21, 2022
On January 19, Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental biologics license application for cemiplimab-rwlc (Libtayo) in combination with chemotherapy as first-line treatment in advanced non–small cell lung cancer (NSCLC). The target action date for the FDA decision is September 19, 2022. The PD-L1 inhibitor was approved in the United States and European Union as first-line monotherapy for adults with locally advanced or metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥ 50%) in 2021.
The current application is supported by results from a randomized, multicenter phase III trial. It investigated the use of cemiplimab in combination with a physician’s choice of platinum-doublet chemotherapy compared with platinum-doublet chemotherapy alone. A total of 466 patients had locally advanced or metastatic NSCLC, irrespective of PD-L1 expression level or tumor histology, and no ALK, EGFR, or ROS1 aberrations. According to the manufacturer, the phase III trial supporting the application was stopped early after the cemiplimab combination demonstrated a significant overall survival improvement compared with chemotherapy alone.