Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial

The combination of cemiplimab and platinum-based doublet chemotherapy has received approval for first-line treatment of patients with locally advanced or metastatic NSCLC. The approval was on the basis of the superior efficacy exhibited by cemiplimab in combination with chemotherapy in the primary phase 3 EMPOWER-Lung 3 trial (NCT03409614). 1 Gogishvili M. Melkadze T. Makharadze T. et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med. 2022; 28: 2374-2380 Crossref PubMed Scopus (30) Google Scholar The 2-year follow-up results and final overall survival (OS) outcomes recently reported by Makharadze et al. 2 Makharadze T. Gogishvili M. Melkadze T. et al. Cemiplimab plus chemotherapy versus chemotherapy alone in advanced non-small cell lung cancer: 2-year follow-up from the phase 3 EMPOWER-lung 3 trial. J Thorac Oncol. 2023; 18: 755-768 Abstract Full Text Full Text PDF Scopus (3) Google Scholar have unveiled noteworthy advantages of cemiplimab in combination with chemotherapy, as compared with chemotherapy alone, with regard to OS, progression-free survival, and objective response rate among patients diagnosed with advanced squamous or nonsquamous NSCLC. 2 Makharadze T. Gogishvili M. Melkadze T. et al. Cemiplimab plus chemotherapy versus chemotherapy alone in advanced non-small cell lung cancer: 2-year follow-up from the phase 3 EMPOWER-lung 3 trial. J Thorac Oncol. 2023; 18: 755-768 Abstract Full Text Full Text PDF Scopus (3) Google Scholar The trial yields promising results; however, before integrating it into clinical practice, several matters should be evaluated. Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 TrialJournal of Thoracic OncologyVol. 18Issue 6PreviewEMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase 3 study, investigated cemiplimab (antiprogrammed cell death protein 1) plus chemotherapy versus placebo plus chemotherapy in patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations, with either squamous or nonsquamous histology, irrespective of programmed death-ligand 1 levels. At primary analysis, after 16.4 months of follow-up, cemiplimab plus chemotherapy improved median overall survival (OS) versus chemotherapy alone (21.9 versus 13.0 mo, hazard ratio [HR] = 0.71, 95% confidence interval [CI]: 0.53–0.93, p = 0.014). Full-Text PDF Open AccessResponse to Letter to the EditorJournal of Thoracic OncologyVol. 18Issue 7PreviewWe thank the readers for their interest in our manuscript reporting protocol-specified final overall survival analysis and 2-year follow-up results from the phase 3 EMPOWER-Lung 3 study.1 In this study, a total of 466 patients with advanced NSCLC (without EGFR, ALK, or ROS1 aberrations) were randomized 2:1 to receive histology-specific platinum-doublet chemotherapy in combination with either 350 mg cemiplimab (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks.1,2 At 28.4 months of follow-up, the median overall survival was 21.1 months (95% confidence interval: 15.9–23.5) for cemiplimab plus chemotherapy versus 12.9 months (95% confidence interval: 10.6–15.7) for chemotherapy alone. Full-Text PDF