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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Thursday, November 10, 2022
On November 8, 2022, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adults with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. This PD-1–blocking antibody is also indicated in the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma and basal cell carcinoma.
Efficacy in lung cancer was evaluated in Study 16113 (ClinicalTrials.gov identifier NCT03409614), a randomized, multicenter, multinational, double-blind, active-controlled trial in 466 patients with advanced NSCLC who had not received prior systemic treatment. Patients were randomly assigned (2:1) to either cemiplimab plus platinum-based chemotherapy every 3 weeks for four cycles followed by cemiplimab and maintenance chemotherapy or placebo plus platinum-based chemotherapy every 3 weeks for four cycles followed by placebo and maintenance chemotherapy.
As assessed by blinded independent central review, cemiplimab plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with 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) with cemiplimab plus chemotherapy and 13.0 months (95% CI = 11.9–16.1 months) with placebo plus chemotherapy. Median progression-free survival per blinded independent central review was 8.2 months (95% CI = 6.4–9.3 months) with cemiplimab plus chemotherapy and 5.0 months (95% CI = 4.3–6.2 months) with placebo plus chemotherapy (HR = 0.56; 95% CI = 0.44–0.70, P < .0001). Confirmed overall response rates per blinded independent central review were 43% (95% CI = 38%–49%) and 23% (95% CI = 16%–30%) with the respective treatments.
The most common (≥ 15%) adverse reactions with cemiplimab were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.
The recommended dose of cemiplimab is 350 mg given intravenously every 3 weeks. For full prescribing information, visit accessdata.fda.gov.
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