Cemiplimab plus chemotherapy versus chemotherapy for advanced NSCLC: 5-year follow-up from EMPOWER-Lung 3 part 2

The multinational phase 3 EMPOWER-Lung 3 part 2 trial demonstrated significant survival benefits with cemiplimab plus chemotherapy versus chemotherapy alone in patients with previously untreated advanced NSCLC without EGFR, ALK, or ROS1 aberrations. Five-year results of the trial have now been published. Patients were randomized 2:1 to cemiplimab 350 mg (n=312) or placebo (n=154) every 3 weeks for up to 108 weeks, plus four cycles of chemotherapy. The primary endpoint was overall survival (OS). After a median follow-up of 60.9 months, median OS was 21.1 months with cemiplimab plus chemotherapy versus 12.9 months with chemotherapy (HR 0.66; p=0.0002), while median progression-free survival (PFS) was 8.2 versus 5.5 months (HR 0.58; p<0.0001). Objective response rate was 43.6% versus 22.1%, and complete response rate was 6.4% versus 0%. Five-year OS probability was 19.4% with cemiplimab plus chemotherapy versus 8.8% with chemotherapy. Incidence of treatment-emergent adverse events of grade 3 or higher was 49.4% with cemiplimab plus chemotherapy and 32.7% with chemotherapy alone. The authors conclude that with 5-year follow-up, cemiplimab plus chemotherapy continues to show long-term efficacy benefits versus chemotherapy alone as first-line therapy for advanced NSCLC.