On 22 February 2021, the US Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC whose tumours have high PD-L1 expression (Tumour 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 multicentre, randomised, open-label study in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or with metastatic NSCLC. Patients were randomised (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 study 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% confidence interval [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 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, anaemia, 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.
Full prescribing information for Libtayo is available here.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review.
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