Additional Immunotherapy Regimen Approved for Lung Cancer 

The immune checkpoint inhibitor cemiplimab-rwlc was approved in combination with chemotherapy for certain patients with non-small cell lung cancer. 

The U.S. Food and Drug Administration (FDA) has approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) without mutations in the EGFR, ALK, or ROS1 genes. 

While patients with NSCLC harboring mutations in EGFR, ALK, or ROS1 may be treated with therapies targeting these mutant proteins, patients whose cancers do not have these mutations are ineligible for such treatments.  

Cemiplimab-rwlc is an immune checkpoint inhibitor, a type of immunotherapy that is designed to boost the body’s antitumor response by inhibiting certain proteins that stop the immune system from attacking cancer cells. Specifically, cemiplimab-rwlc inhibits the interaction of the PD-1 and PD-L1 proteins. Additional immune checkpoint inhibitors, including atezolizumab and pembrolizumab, were previously approved to treat certain patients with NSCLC.  

The approval of cemiplimab-rwlc in combination with platinum-based chemotherapy is based on results from the randomized, multicenter, multinational, double-blind, active-controlled clinical trial Study 16113. The trial enrolled 466 patients with advanced NSCLC who had not received prior systemic therapy. Patients were randomly assigned to receive either cemiplimab-rwlc plus platinum-based chemotherapy or placebo plus platinum-based chemotherapy.  

Patients in the cemiplimab-rwlc arm were 29 percent less likely to die than those in the placebo arm, a statistically significant difference. The median overall survival was significantly longer among patients in the cemiplimab-rwlc arm than those in the placebo arm (21.9 months vs. 13 months). Patients in the cemiplimab-rwlc arm also had significantly longer progression-free survival than those in the placebo group (8.2 months vs. 5 months). Forty-three percent of patients who received the cemiplimab-rwlc regimen had a clinical response, as opposed to 23 percent of patients treated with the placebo regimen. 

Lung cancer is among the most commonly diagnosed cancers in the United States. In 2022, it was estimated that 236,740 new cases would be diagnosed, and 130,180 individuals would die of the disease in the U.S.  

The FDA rendered its decision on November 8, 2022.