Cemiplimab Plus Chemotherapy Versus Chemotherapy in Advanced NSCLC: 5-Year Results From Phase 3 EMPOWER-Lung 3 Part 2 Trial.
Ana Baramidze, Tamta Makharadze, Miranda Gogishvili et al.
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In 30 seconds
This phase III, multicenter randomized trial compared first-line cemiplimab plus chemotherapy with chemotherapy alone in previously untreated patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations. At a median follow-up of 60.9 months, median overall survival was 21.1 months with the combination versus 12.9 months with chemotherapy alone (hazard ratio 0.66 [95% confidence interval: 0.53-0.83], p = 0.0002). Five-year overall survival probability was 19.4% versus 8.8%, respectively. The authors report durable efficacy in both squamous and nonsquamous disease, alongside more grade 3 or higher treatment-emergent adverse events with the combination.
Key findings
- Median overall survival was 21.1 months with cemiplimab plus chemotherapy versus 12.9 months with 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).
- Five-year overall survival probability was 19.4% with the combination versus 8.8% with chemotherapy alone.
- Grade 3 or higher treatment-emergent adverse events occurred in 49.4% versus 32.7%, respectively.
Why it matters
The extended follow-up indicates that the survival advantage reported for adding cemiplimab to chemotherapy persisted over five years, with benefit reported across both major histologic groups. The results also show a higher incidence of severe treatment-emergent adverse events with the combination, making the efficacy and safety findings relevant together when considering first-line treatment evidence for this population.