Dr. Sezer on the FDA Approval of Cemiplimab in Frontline Advanced NSCLC With High PD-L1 Expression

Ahmet Sezer, MD, professor, Department of Medical Oncology, Başkent University, Adana, Turkey, discusses the FDA approval of cemiplimab-rwlc (Libtayo) as frontline treatment for patients with advanced non–small cell lung cancer (NSCLC) and high PD-L1 expression.

On February 22, 2021, the FDA approved cemiplimab monotherapy for use as frontline treatment for patients with advanced NSCLC with a PD-L1 expression level of 50% or higher. The regulatory decision was based on findings from the phase 3 EMPOWER-Lung1 trial, in which cemiplimab reduced the risk of death by 32% compared with chemotherapy in patients with a PD-L1 expression of 50% or higher.

Cemiplimab provides another effective option for patients with advanced NSCLC who have high PD-L1 expression, says Sezer. Moreover, findings from the EMPOWER-Lung1 trial have confirmed clinical benefit for this patient population with cemiplimab despite a high crossover rate and broadened inclusion criteria, Sezer explains. However, as advanced NSCLC is a heterogenous disease, additional research efforts are needed to further improve survival for this subset of patients, concludes Sezer.