Cemiplimab Regimen Extends Survival in Advanced NSCLC

Cemiplimab plus chemotherapy continued to show improved outcomes compared with chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC), according to 2-year follow-up results from the phase 3 EMPOWER-Lung 3 part 2 trial published in the Journal of Thoracic Oncology.

The randomized, double-blind, placebo-controlled trial evaluated cemiplimab, an anti-programmed cell death protein 1 therapy, plus histology-specific platinum-doublet chemotherapy versus placebo plus chemotherapy in patients with advanced squamous or nonsquamous NSCLC without EGFR, ALK, or ROS1 tumor genomic aberrations. The study included patients regardless of programmed death-ligand 1 (PD-L1) expression level.

A total of 466 patients were randomized 2:1 to receive cemiplimab 350 mg or placebo every 3 weeks with four cycles of chemotherapy. Treatment continued for up to 108 weeks or until disease progression or unacceptable toxicity. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), safety, and duration of response.

After a median follow-up of 28.4 months, median OS was 21.1 months with cemiplimab plus chemotherapy compared with 12.9 months with chemotherapy alone (hazard ratio [HR], 0.65; 95% CI, 0.51-0.82; P=.0003). Median PFS was 8.2 months versus 5.5 months, respectively (HR, 0.55; 95% CI, 0.44-0.68; P<.0001), and ORR was 43.6% versus 22.1% (P<.0001).

Safety findings were generally consistent with earlier reports. Grade 3 or higher treatment-emergent adverse events occurred in 48.7% of patients receiving cemiplimab plus chemotherapy and 32.7% of patients receiving chemotherapy alone. The authors concluded that the final analysis supported continued benefit with cemiplimab plus platinum-doublet chemotherapy in advanced squamous and nonsquamous NSCLC across PD-L1 expression levels.

Source: Makharadze T, Gogishvili M, Melkadze T, et al. Cemiplimab plus chemotherapy versus chemotherapy alone in advanced NSCLC: 2-year follow-up from the phase 3 EMPOWER-Lung 3 part 2 trial. J Thorac Oncol. 2023;18(6):755-768. doi:10.1016/j.jtho.2023.03.008