On November 8, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.
Efficacy was evaluated in Study 16113 (ClinicalTrials.gov identifier NCT03409614), a randomized, multicenter, multinational, double-blind, active-controlled trial of 466 patients with advanced NSCLC who had not received prior systemic treatment. Patients were randomly assigned 2:1 to receive either cemiplimab-rwlc plus platinum-based chemotherapy every 3 weeks for four cycles followed by cemiplimab-rwlc and maintenance chemotherapy, or placebo plus platinum-based chemotherapy every 3 weeks for four cycles followed by placebo and maintenance chemotherapy.
The main efficacy outcome measure was overall survival; additional efficacy outcome measures were progression-free survival and overall response rate as assessed by blinded independent central review.
Cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy (hazard ratio [HR] = 0.71, 95% confidence interval [CI] = 0.53–0.93], two-sided P = .0140). Median overall survival was 21.9 months (95% CI = 15.5 months to not evaluable) in the cemiplimab-rwlc plus chemotherapy arm and 13.0 months (95% CI = 11.9–16.1 months) in the placebo plus chemotherapy arm. Median progression-free survival per blinded independent central review was 8.2 months (95% CI = 6.4–9.3 months) in the cemiplimab-rwlc plus chemotherapy arm and 5.0 months (95% CI = 4.3–6.2 months) in the placebo plus chemotherapy arm (HR = 0.56, 95% CI = 0.44–0.70, P < .0001). Confirmed overall response rate per blinded independent central review was 43% (95% CI = 38%–49%) and 23% (95% CI = 16%–30%) in the respective treatment arms.
The most common (≥ 15%) adverse reactions in the cemiplimab-rwlc arm were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.
The recommended cemiplimab-rwlc dose is 350 mg intravenously every 3 weeks. Refer to the prescribing information for the agents administered in combination with cemiplimab-rwlc for recommended dosing information, as appropriate.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.