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.
“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.
The main efficacy measure was overall survival (OS). Additional measures were 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, 0.440.70; 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.