FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer

On November 8, 2022, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) 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 (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 randomized (2:1) to either cemiplimab-rwlc plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by cemiplimab-rwlc and maintenance chemotherapy or placebo plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by placebo and maintenance chemotherapy.

The main efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were progression-free survival (PFS) and overall response rate (ORR) as assessed by blinded independent central review (BICR).

Cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo plus chemotherapy (hazard ratio [HR] of 0.71 [95% CI: 0.53, 0.93], two-sided p-value = 0.0140). Median OS was 21.9 months (95% CI: 15.5, not evaluable) in the cemiplimab-rwlc plus chemotherapy arm and 13.0 months (95% CI: 11.9, 16.1) in the placebo plus chemotherapy arm. Median PFS per BICR was 8.2 months (95% CI: 6.4, 9.3) in the cemiplimab-rwlc plus chemotherapy arm and 5.0 months (95% CI: 4.3, 6.2) in the placebo plus chemotherapy arm (HR 0.56; 95% CI: 0.44, 0.70, p<0.0001). Confirmed ORR per BICR was 43% (95% CI: 38, 49) and 23% (95% CI: 16, 30) in the respective treatments.

The most common (≥15%) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.

The recommended cemiplimab-rwlc dose is 350 mg IV every 3 weeks. Refer to the prescribing information for the agents administered in combination with cemiplimab-rwlc for recommended dosing information, as appropriate.

View full prescribing information for Libtayo

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

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