FDA Approves Cemiplimab-rwlc for Non-small Cell Lung Cancer with High PD-L1 Expression

February 22, 2021

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.

Efficacy was evaluated in Study 1624 (NCT03088540), a multi-center, randomized, open-label trial in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or with metastatic NSCLC. Patients were randomized (1:1) to receive cemiplimab-rwlc 350 mg intravenously every 3 weeks for up to 108 weeks or a platinum-based chemotherapy. The main efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) per blinded independent central review (BICR). 

The trial demonstrated statistically significant improvements in OS and PFS for patients receiving cemiplimab-rwlc compared to those treated with platinum-based chemotherapy. Median OS was 22.1 months (95% CI:17.7, NE) for patients in the cemiplimab-rwlc arm compared with 14.3 months (95% CI: 11.7, 19.2) in the chemotherapy arm (HR 0.68; 95%CI: 0.53, 0.87, p=0.0022). Median PFS per BICR was 6.2 months (4.5, 8.3) in the cemiplimab-rwlc arm and 5.6 months (4.5, 6.1) in the chemotherapy arm (HR 0.59; 95% CI: 0.49, 0.72, p<0.0001). Confirmed overall response rate (ORR) per BICR was 37% (95% CI: 32, 42) and 21% (95% CI: 17, 25) in the cemiplimab-rwlc and chemotherapy arms, respectively. 

The most common adverse reactions (> 10%) with cemiplimab-rlwc as a single agent in Study 1624 were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough. 

The recommended cemiplimab-rwlc dose for treatment of NSCLC is 350 mg every 3 weeks, intravenously over 30 minutes.

View full prescribing information for Libtayo

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

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