What is the role of cemiplimab in the treatment of metastatic non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Like nivolumab and pembrolizumab, cemiplimab is a monoclonal antibody to PD-1. Cemiplimab was granted accelerated approval for first-line therapy in metastatic NSCLC patients with high PD-L1 expressed (TPS ≥50%) tumors and no EFGR, ALK, or ROS-1 mutations.

Efficacy was evaluated in Study 1624, a multicenter, open-label trial which enrolled 710 patients with localized advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation, or with metastatic NSCLC. Patients were randomly assigned to receive either cemiplimab or a platinum-based chemotherapy.

There were statistically significant improvements in OS and PFS in Study 1624. The cemiplimab arm had a higher median OS and PFS (22.1 months, 6.2 months) compared to the chemotherapy arm (14.3 months, 5.6 months). [145]


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