Cemiplimab Plus Chemotherapy Versus Chemotherapy in Advanced NSCLC: 5-Year Results From Phase 3 EMPOWER-Lung 3 Part 2...

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. Here, we report 5-year follow-up outcomes.

Patients were randomized 2:1 to receive cemiplimab (350 mg every 3 wk for up to 108 wk) or placebo plus four cycles of chemotherapy. Primary end point was overall survival (OS); secondary end points included progression-free survival and objective response rate.

This study randomized 466 patients to cemiplimab plus chemotherapy (n = 312) or chemotherapy alone (n = 154). After a median follow-up of 60.9 months, median OS was 21.1 months for cemiplimab plus chemotherapy versus 12.9 months for chemotherapy alone (hazard ratio = 0.66 [95% confidence interval: 0.53-0.83], p = 0.0002); median progression-free survival was 8.2 months versus 5.5 months (hazard ratio = 0.58 [95% confidence interval: 0.47-0.72], p < 0.0001); objective response rate was 43.6% versus 22.1%; and complete response was observed in 6.4% of patients (20/312) versus 0% (0/154), respectively. Five-year OS probability was 19.4% for cemiplimab plus chemotherapy versus 8.8% for chemotherapy alone. Efficacy was demonstrated in both squamous and nonsquamous histology. For 22.8% of patients (71/312) who completed 36 cycles of cemiplimab treatment, OS probability was 57.3% at 3 years after treatment completion (approximately 5 y after randomization). Among the total study population, incidence of treatment-emergent adverse events of grade 3 or higher was 49.4% with cemiplimab plus chemotherapy and 32.7% with chemotherapy alone.

With 5-year follow-up, cemiplimab plus chemotherapy continues to demonstrate durable long-term efficacy benefits versus chemotherapy alone with consistent safety profile, as first-line therapy for advanced NSCLC.