Cemiplimab-rwlc is approved by FDA in combination with platinum-based chemotherapy for non-small cell lung cancer

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November 2022: The combination of cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) and platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 abnormalities has been approved by the Food and Drug Administration.

Study 16113 (NCT03409614), a randomised, multicenter, international, double-blind, active-controlled trial in 466 patients with advanced NSCLC who had not previously undergone systemic treatment, assessed the effectiveness in this regard. 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, were the two treatment options offered to patients who were randomly assigned (2:1).


Overall survival was the primary efficacy outcome measurement (OS). Progression-free survival (PFS) and overall response rate (ORR), as determined by a blinded independent central review, were additional efficacy outcome measures (BICR).

In comparison to placebo plus chemotherapy, cemiplimab-rwlc plus platinum-based chemotherapy showed a statistically significant and clinically significant improvement in overall survival (OS) (hazard ratio [HR] of 0.71 [95% CI: 0.53, 0.93], two-sided p-value = 0.0140). In the cemiplimab-rwlc plus chemotherapy arm, the median OS was 21.9 months (95% CI: 15.5, not evaluable), compared to 13.0 months (95% CI: 11.9, 16.1) in the placebo plus chemotherapy group. In the cemiplimab-rwlc plus chemotherapy arm, the median PFS per BICR was 8.2 months (95% CI: 6.4, 9.3), while it was 5.0 months (95% CI: 4.3, 6.2) in the placebo plus chemotherapy arm (HR 0.56; 95% CI: 0.44, 0.70, p0.0001). Confirmed ORR per BICR for the two treatments was 43% (95% CI: 38, 49) and 23% (95% CI: 16, 30).

Alopecia, musculoskeletal pain, nausea, exhaustion, peripheral neuropathy, and decreased appetite were the most frequent side effects (15%).

350 mg IV every three weeks is the suggested dose of cemiplimab-rwlc. For recommended dose information, as necessary, see the prescribing information for the medications used in conjunction with cemiplimab-rwlc.

 

View full prescribing information for Libtayo

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