August 2021: The FDA 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 tumours have high PD-L1 expression (Tumor Proportion Score [TPS] > 50 percent) whose tumours have high PD-L
Study 1624 (NCT03088540), a multicenter, randomised, open-label trial in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation, or with metastatic NSCLC, was conducted to assess efficacy. Patients were given either cemiplimab-rwlc 350 mg intravenously every 3 weeks for up to 108 weeks or platinum-based chemotherapy. Per a blinded independent central review, the major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) (BICR).
Patients who received cemiplimab-rwlc had statistically significant increases in OS and PFS when compared to those who received platinum-based chemotherapy. Patients in the cemiplimab-rwlc group had a median OS of 22.1 months (95 percent CI: 17.7, NE), compared to 14.3 months (95 percent CI: 11.7, 19.2) in the chemotherapy arm (HR 0.68; 95 percent CI: 0.53, 0.87, p=0.0022). The cemiplimab-rwlc arm had a median PFS of 6.2 months (4.5, 8.3) and the chemotherapy arm had a median PFS of 5.6 months (4.5, 6.1) (HR 0.59; 95 percent CI: 0.49, 0.72, p0.0001). In the cemiplimab-rwlc and chemotherapy groups, the confirmed overall response rate (ORR) per BICR was 37 percent (95 percent CI: 32, 42) and 21 percent (95 percent CI: 17, 25), respectively.
Musculoskeletal discomfort, rash, anaemia, exhaustion, decreased appetite, pneumonia, and cough were the most prevalent adverse events (> 10%) with cemiplimab-rlwc as a single drug in Study 1624.
The suggested dose of cemiplimab-rwlc for NSCLC treatment is 350 mg every three weeks, administered intravenously over 30 minutes.
Reference : https://www.fda.gov/
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