In November 2022, the FDA approved the immunotherapy Libtayo (cemiplimab-rwlc; from Regeneron), a PD-L1 inhibitor, in combination with platinum-based chemotherapy, for the treatment of patients with advanced non–small-cell lung cancer (NSCLC) that does not have EGFR, ALK, or ROS1 genomic aberrations.
The FDA approved Libtayo plus chemotherapy for this indication based on a randomized, multicenter, multinational, double-blind, active-controlled clinical trial of 466 patients with advanced NSCLC who had not received systemic treatment. The patients received either Libtayo plus platinum-based chemotherapy or placebo plus platinum-based chemotherapy.
“Clearly, this is an advance which is clinically meaningful for our patients with advanced stage non–small-cell lung cancer,” said David R. Gandara, MD, Director, Thoracic Oncology Program, University of California Davis Comprehensive Cancer Center, Sacramento.
Libtayo plus chemotherapy demonstrated significantly longer survival than placebo plus chemotherapy. The average survival was 21.9 months with Libtayo plus chemotherapy versus 13 months with placebo plus chemotherapy. The average time without disease progression was 8.2 months in the Libtayo group versus 5 months in the placebo group. Overall, 43% of patients had a response to Libtayo plus chemotherapy versus 23% in the placebo group.
The most common side effects with Libtayo plus chemotherapy were hair loss, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.
