Dr. Gogishvili on the Rationale for the EMPOWER-Lung 3 Trial in NSCLC

Miranda Gogishvili, MD, medical oncologist, High Technology Medical Center, University Clinic, Tbilisi, Georgia, discusses the rationale for the phase 3 EMPOWER-Lung 3 trial (NCT03409614) in advanced or metastatic non–small cell lung cancer (NSCLC).

On February 22, 2021, the FDA approved cemiplimab-rwlc (Libtayo) for the frontline treatment of patients with advanced NSCLC with a PD-L1 expression level of 50% or higher who don’t harbor EGFR, ALK, or ROS1 aberrations and are ineligible for definitive chemoradiation. On June 25, 2021, the agent was approved by the European Commission for the same indication.

The regulatory decisions were based on findings from the international phase 3 EMPOWER-Lung 1 trial (NCT03088540), in which frontline cemiplimab induced a 32% reduction in the risk of death compared with chemotherapy in this patient population.

The EMPOWER-Lung 3 trial sought to evaluate cemiplimab in combination with platinum-doublet chemotherapy in patients with advanced or metastatic NSCLC, Gogishvili says. The results of the trial, which were presented during the 2021 ESMO Congress, demonstrated a clinically meaningful and statistically significant improvement in overall survival, progression-free survival, overall response rate, and duration of response with the combination of cemiplimab and chemotherapy vs chemotherapy alone in this patient population. Moreover, the improvement was observed in patients with squamous and nonsquamous histologies, across PD-L1 expression levels above 1%, and across diverse disease characteristics that are commonly observed in clinical practice, Gogishvili concludes.