FDA Approves Cemiplimab-Rwlc for Patients With NSCLC and High PD-L1 Expression

On February 22, 2021, the FDA approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals), a PD-1 blocking antibody, for the first-line treatment of patients with advanced non–small-cell lung cancer (NSCLC) with high PD-L1 expression and no EGFR, ALK, or ROS1 aberrations.

The efficacy of cemiplimab-rwlc was evaluated in Study 1624, which enrolled 710 patients with locally advanced NSCLC not eligible for surgical resection or definitive chemoradiation, or with metastatic NSCLC. These patients were randomized to receive intravenous cemiplimab-rwlc or a platinum-based chemotherapy.

Patients in the cemiplimab-rwlc arm had a median overall survival of 22.1 months (95% CI, 17.7. to not estimable) compared with 14.3 months (95% CI, 11.7-19.2) in the chemotherapy arm (hazard ratio [HR], 0.68; 95% CI, 0.53-0.87; P = .0022).

The median progression-free survival was 6.2 months (95% CI, 4.5-8.3) and 5.6 months (95% CI, 4.5-6.1) in the cemiplimab-rwlc and chemotherapy arms, respectively (HR, 0.59; 95% CI, 0.49-0.72; P <.0001). The confirmed overall response rate was 37% (95% CI, 32-42) in the cemiplimab-rwlc arm and 21% (95%, CI, 18-25) in the chemotherapy arm.

The most common (≥10%) adverse events associated with cemiplimab-rwlc include musculoskeletal pain, rash, amnesia, fatigue, decreased appetite, pneumonia, and cough.—Emily Bader

Source: US Food and Drug Administration. FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression. February 22, 2021. Accessed February 22, 2021.

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