Dr Santos on the Impact of Cemiplimab With Chemotherapy in Squamous NSCLC

Edgardo S. Santos, MD, FACP, clinical affiliate associate professor, Charles E. Schmidt College of Medicine, Florida Atlantic University, founding partner, Florida Precision Oncology, discusses the impact of treatment with cemiplimab (Libtayo) plus chemotherapy in patients with squamous non–small cell lung cancer (NSCLC).

The phase 3 EMPOWER-Lung 3 trial (Study 16113; NCT03409614) investigated the combination of cemiplimab and chemotherapy vs chemotherapy alone in patients with advanced or metastatic NSCLC. Notably, patients were permitted to have squamous or nonsquamous histology, and this study was one of the largest to date with a high proportion of patients with squamous NSCLC, Santos says. Forty-three percent of 466 patients had squamous NSCLC.

In November 2022, findings from EMPOWER 3 supported the FDA approval of cemiplimab in combination with platinum-based chemotherapy in adult patients with advanced NSCLC with no EGFR, ALK, or ROS1aberrations.

In the overall population, the combination elicited a median overall survival (OS) of 21.9 months (95% CI, 15.5–not evaluable) vs 13.0 months (95% CI, 11.9-16.1) for chemotherapy alone. In a post-hoc analysis of the trial, patients with squamous NSCLC who received cemiplimab plus chemotherapy maintained the OS benefit observed in the intent-to-treat population, Santos notes.

The phase 3 EMPOWER-Lung 1 trial (NCT033088540), which supported the February 2022 FDA approval of cemiplimab monotherapy for the frontline treatment of patients with advanced NSCLC with a PD-L1 expression level of 50% or higher, also had 43% of patients with squamous histology. Given the activity observed with cemiplimab alone and in combination chemotherapy in patients with historically more aggressive histology, further exploration of this approach is warranted, Santos concludes.