Cemiplimab and Platinum Chemotherapy Receive FDA Approval for First-Line Lung Cancer Treatment

For advanced non-small cell lung cancer (NSCLC) without EGFR, ALK or ROS1 mutations, the combination of platinum-based chemotherapy and cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) immunotherapy received FDA (US Food and Drug Administration) approval on 8 November 2022.

Cemiplimab’s 4th FDA Approval

Cemiplimab, an anti-PD-1 immunotherapy, had previously received FDA approval for squamous cell skin cancer in 2018, basal cell skin cancer in 2021 and, also in 2021, first-line treatment of non-small cell lung cancer with PD-L1 TPS>=50% .

The 4th First-Line Immunotherapy–Chemotherapy Approval in NSCLC

This became the 4th immunotherapy–chemotherapy combination approved for first-line advanced NSCLC regardless of PD-L1. Pembrolizumab, atezolizumab and nivolumab–ipilimumab immunotherapies had previously been approved with platinum-based chemotherapy for patients in this setting.

FDA Approval Based on Study 16113

Cemiplimab efficacy was evaluated in Study 16113, a randomised, multicentre, multinational, double-blind, active-controlled trial in 466 patients with advanced NSCLC who had not received systemic treatment. Patients were randomised 2:1 to 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 treatment.

The main efficacy outcome was overall survival. Additional outcomes were progression-free survival and overall response rate, assessed by blinded independent central review.

Results

• Cemiplimab plus platinum-based chemotherapy significantly improved overall survival, both statistically and clinically, compared with placebo plus chemotherapy: risk of death fell by 29% (hazard ratio [HR] 0.71 [95% CI: 0.53, 0.93], two-sided p-value = 0.0140).
• Median overall survival was 21.9 months (95% CI: 15.5, not evaluable) in the cemiplimab plus chemotherapy arm and 13 months (95% CI: 11.9, 16.1) in the placebo plus chemotherapy arm.
• Median progression-free survival was 8.2 months (95% CI: 6.4, 9.3) with cemiplimab plus chemotherapy and 5 months (95% CI: 4.3, 6.2) with placebo plus chemotherapy (HR 0.56; 95% CI: 0.44, 0.70, p<0.0001).
• Overall response rate in the immunotherapy arm was 43% (95% CI: 38, 49), compared with 23% (95% CI: 16, 30) in the comparator arm.

The most common (≥15%) adverse effects were alopecia (hair loss), musculoskeletal pain, nausea, fatigue, peripheral neuropathy (nerve damage in the extremities) and reduced appetite.

The recommended cemiplimab-rwlc dose is 350 mg IV every 3 weeks.

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