Is cimepilimab approved for non-small cell lung cancer?

In February 2021, The U.S. Food and Drug Administration (FDA) approved cemiplimab (Cemiplimab)-Libtayo for the treatment of advanced non-small cell lung cancer (NSCLC) (locally advanced, not suitable for surgery) Resection or definitive chemoradiotherapy or metastasis) First-line treatment for patients whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] >50%) , as determined by FDA-approved testing, without EGFR, ALK, or ROS1 abnormalities.

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

The trial showed that patients who received cimepilimab had a statistically significant improvement in OS and PFS compared with patients who received platinum-based chemotherapy. The median OS of patients in the cimepilimab group was 22.1 months (95% CI: 17.7, NE), compared with 14.3 months (95% CI: 11.7-19.2) in the chemotherapy group (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 cimepilimab group and 5.6 months (4.5-6.1) in the chemotherapy group (HR 0.59; 95% CI: 0.49-0.72, p<0.0001). The confirmed overall response rate (ORR) per BICR was 37% (95% CI: 32-42) and 21% (95% CI: 17-25) in the cimepilimab and chemotherapy arms, respectively.

In Study 1624, the most common adverse reactions (>10%) with cimepilimab alone were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough. The recommended dose of cimipilimab for the treatment of non-small cell lung cancer is 350 mg intravenously over 30 minutes every 3 weeks.

References:https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-non-small-cell-lung-cancer-high-pd-l1-expression