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 ROS1aberrations.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, the primary outcome measure, 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 central 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. Product labeling provides instructions on dose modification for immune-mediated adverse reactions and infusion-related reactions.

Safety Profile

In Study 16113, the most common (≥ 20%) adverse events of any grade in the cemiplimab group were alopecia (37% vs 43% in the control group), musculoskeletal pain (30% vs 36%), nausea (25% vs 16%), fatigue (23% vs 18%), and peripheral neuropathy (23% vs 19%). The most common grade 3 or 4 adverse events included fatigue (3.8% vs 2.0%) and dyspnea (2.2% vs 0.7%). The most common grade 3 or 4 laboratory abnormalities were decreased neutrophils (10% vs 8%), anemia (10% vs 7%), and decreased lymphocytes (7% vs 8%).

Serious adverse events occurred in 25% of the cemiplimab group, most commonly (≥ 2%) pneumonia, anemia, and neutropenia. Adverse events led to discontinuation of cemiplimab in 5%; the most common causes were increased alanine aminotransferase and anemia (two patients each). Adverse events led to death in 6% of patients; fatalities were attributed to death not otherwise specified (2.9%), sudden death (1.0%), acute hepatitis (0.3%), acute respiratory distress syndrome (0.3%), mesenteric artery thrombosis (0.3%), pneumonia (0.3%), pneumonitis (0.3%), and pulmonary hemorrhage (0.3%).

Cemiplimab has warnings/precautions for immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, nephritis and renal dysfunction, and solid organ transplantation rejection; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation; and embryofetal toxicity. Patients should be advised not to breastfeed while receiving cemiplimab.

REFERENCE

1. Libtayo (cemiplimab-rwlc) injection, for intravenous use, prescribing information, Regeneron Pharmaceuticals, Inc., November 2022. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761 097s014lbl.pdf. Accessed November 16, 2022.