On November 8, 2022, the FDA approved a new indication for cemiplimab-rwlc (Libtayo; Regeneron), a PD-1 inhibitor, in combination with platinum-based chemotherapy, for the treatment of adults with advanced non–small-cell lung cancer (NSCLC) and no EGFR, ALK, or ROS1 aberrations.
Libtayo was previously approved for first-line treatment of advanced or metastatic NSCLC with PD-1 expression of ≥50% but with no EGFR, ALK, or ROS1 aberrations, in addition to the treatment of cutaneous squamous-cell carcinoma and basal-cell carcinoma.
The FDA approved this new indication based on results of Study 1611, a randomized, multicenter, multinational, double-blind, active-controlled clinical trial of 466 patients with advanced NSCLC who had not received systemic treatment.
The patients were randomized in a 2:1 ratio to cemiplimab plus platinum-based chemotherapy every 3 weeks for 4 cycles, followed by cemiplimab and maintenance chemotherapy, or to placebo plus platinum-based chemotherapy every 3 weeks for 4 cycles, followed by placebo and maintenance chemotherapy.
The main efficacy measure was overall survival (OS). Additional measures included progression-free survival (PFS) and overall response rate (ORR).
Cemiplimab plus chemotherapy demonstrated significant and clinically meaningful improvement in OS versus placebo plus chemotherapy (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.53-0.93; 2-sided P = .0140). The median OS was 21.9 months (95% CI, 15.5-not evaluable) with cemiplimab plus chemotherapy and 13 months (95% CI, 11.9-16.1) with placebo plus chemotherapy. The median PFS was 8.2 months (95% CI, 6.4-9.3) in the cemiplimab arm versus 5 months (95% CI, 4.3-6.2) in the placebo arm (HR, 0.56; 95% CI, 0.44-0.70; P <.0001). The ORR was 43% (95% CI, 38-49) and 23% (95% CI, 16-30), respectively.
The most common (≥15%) adverse events in the study were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.