On February 22, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations.
Efficacy was evaluated in Study 1624, a multicenter, randomized, open-label trial of 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation, or with metastatic NSCLC. Patients were randomly assigned 1:1 to receive either cemiplimab-rwlc at 350 mg intravenously every 3 weeks for up to 108 weeks or a platinum-based chemotherapy. The main efficacy outcome measures were overall survival and progression-free survival per blinded independent central review.
The trial demonstrated statistically significant improvements in overall and progression-free survival for patients receiving cemiplimab-rwlc compared to those treated with platinum-based chemotherapy. Median overall survival was 22.1 months (95% confidence interval [CI] = 17.7–not evaluable) for patients in the cemiplimab-rwlc arm compared with 14.3 months (95% CI = 11.7–19.2) in the chemotherapy arm (hazard ratio [HR] = 0.68, 95% CI = 0.53–0.87, P = .0022).
Median progression-free survival per blinded independent central review was 6.2 months (range = 4.5–8.3) in the cemiplimab-rwlc arm and 5.6 months (range = 4.5–6.1) in the chemotherapy arm (HR = 0.59, 95% CI = 0.49–0.72, P < .0001). The confirmed overall response rate per blinded independent central review was 37% (95% CI = 32%–42%) and 21% (95% CI = 17%–25%) in the cemiplimab-rwlc and chemotherapy arms, respectively.
The most common adverse reactions (> 10%) in patients treated with single-agent cemiplimab-rlwc in Study 1624 were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.
The recommended cemiplimab-rwlc dose for treatment of NSCLC is 350 mg every 3 weeks, intravenously over 30 minutes.