On November 8, 2022, cemiplimab-rwlc was approved for use in combination with platinum-based chemotherapy for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.1
Supporting Efficacy Data
Approval was supported by findings in the double-blind Study 16113 (ClinicalTrials.gov identifier NCT03409614). In this trial, a total of 465 patients with no prior systemic treatment were randomly assigned on a 2:1 basis to receive cemiplimab at 350 mg (n = 312) or placebo (n = 153) every 3 weeks plus platinum-based chemotherapy every 3 weeks for four cycles.
Median overall survival was 21.9 months (95% confidence interval [CI] = 15.5 months to not evaluable) in the cemiplimab group vs 13.0 months (95% CI = 11.9–16.1 months) in the control group (hazard ratio [HR] = 0.71, 95% CI = 0.53–0.93, P = .0140). Median progression-free survival on blinded independent review was 8.2 months (95% CI = 6.4–9.3 months) vs 5.0 months (95% CI = 4.3–6.2 months; HR = 0.56, 95% CI = 0.44–0.70, P < .0001). Objective response rates were 43% vs 23%.
How It Is Used
The recommended cemiplimab dose in the current indication is 350 mg intravenously every 3 weeks until disease progression or unacceptable toxicity. No dose reductions are recommended.
In Study 16113, the most common (≥ 20%) adverse events of any grade in the cemiplimab group were alopecia, musculoskeletal pain, nausea, fatigue, and peripheral neuropathy. The most common grade 3 or 4 laboratory abnormalities were decreased neutrophils, anemia, and decreased lymphocytes.
Cemiplimab has warnings/precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryofetal toxicity.
Cemiplimab has warnings/precautions for immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation; and embryofetal toxicity. Patients should be advised not to breastfeed while receiving cemiplimab.
1. Libtayo (cemiplimab-rwlc) injection, for intravenous use, prescribing information, Regeneron Pharmaceuticals, November 2022. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761 097s014lbl.pdf. Accessed November 16, 2022.