The FDA has approved cemiplimab-rwlc as a first-line treatment for advanced non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR, ALK, or ROS1 aberrations.  

The approval follows study 1624, which included 710 patients who were not candidates for resection, definitive radiation, or had metastatic disease.  

Patients enrolled were randomized to receive either the treatment every three weeks for up to 108 weeks or a platinum-based chemotherapy. The primary endpoints were overall survival and progression-free survival.  

According to a release from the FDA, the treatment demonstrated statistically significant improvements in both fields. The median overall survival was 22.1 months (95% CI: 17.7-NE) for patients in the drug arm and 14.3 months (95% CI: 11.7-19.2) in the chemotherapy arm (HR 0.68; 95% CI: 0.53, 0.87, p=0.0022).  

The median progression-free survival per blinded independent central review (BICR) was 6.2 months (4.5, 8.3) in the drug arm and 5.6 months (4.5-6.1) in the chemotherapy arm. The confirmed overall response rate per BICR was 37% (95% CI: 32, 42) in the drug arm and 21% (95% CI: 17, 25) in the chemotherapy arm.  

The most common adverse reactions in the drug arm included musculoskeletal pain, rash, and anemia.  

The FDA had previously granted cemiplimab-rwlc priority review.  


By Adam Hochron