Cemiplimab Immunotherapy Receives FDA Approval for Lung Cancer With High PD-L1 Positivity

On 22 February 2021, the FDA (US Food and Drug Administration) approved first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) using the immunotherapy cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.). As a condition of use, patients must not have EGFR, ALK or ROS1 genetic mutations, and their tumors must have high PD-L1 positivity (Tumor Proportion Score [TPS] > 50%), as determined by an FDA-approved test.

Cemiplimab is an anti-PD-1 immune checkpoint inhibitor whose efficacy was evaluated in Study 1624 (NCT03088540), a multicenter, randomized, open-label trial in 710 patients with advanced NSCLC. Patients were randomly assigned 1:1 to receive either intravenous cemiplimab-rwlc 350 mg every 3 weeks for up to 108 weeks or platinum-based chemotherapy. The main efficacy outcome measures, assessed by blinded independent central review, were overall survival (OS) and progression-free survival (PFS).

The study demonstrated statistically significant improvements in OS and PFS in patients receiving cemiplimab-rwlc compared with those treated with platinum-based chemotherapy.

• Median overall survival was 22.1 months in the immunotherapy arm (95% CI: 17.7, NE), compared with 14.3 months in the chemotherapy arm (95% CI: 11.7, 19.2)
• Compared with chemotherapy, the reduction in the risk of death for patients in the cemiplimab-rwlc arm was 32%. (HR 0.68; 95% CI: 0.53, 0.87, p = 0.0022).
• Median progression-free survival 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).
• The confirmed overall response rates in the cemiplimab-rwlc and chemotherapy arms were 37% (95% CI: 32, 42) and 21% (95% CI: 17, 25), respectively.

In Study 1624, the most common ( > 10%) side effects with single-agent cemiplimab-rlwc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia (lung infection), and cough.

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