The following is a summary of “Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial,” published in the June 2023 issue of the Thoracic Oncology by Tamta et al.
In EMPOWER-Lung 3 part 2 (NCT03409614), a double-masked, placebo-controlled phase 3 study, cemiplimab (anti-programmed cell death protein 1) plus chemotherapy was compared to placebo plus chemotherapy in patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations, regardless of programmed death-ligand 1 level. Cemiplimab plus chemotherapy improved median overall survival (OS) after 16.4 months of follow-up compared to chemotherapy alone (21.9 versus 13.0 mo, hazard ratio [HR] = 0.71, 95% CI: 0.53–0.95, P= 0.014). Here, researchers report the final OS and 2-year follow-up results specified by the protocol.
Patients (N = 466) were randomly assigned to receive histology-specific platinum-doublet chemotherapy with 350 mg of cemiplimab (n = 312) or placebo (n = 154) every three weeks for up to 108 weeks. The primary endpoint was OS, with progression-free survival and objective response rates as secondary endpoints. After 28.4 months of median follow-up, median OS was 21.1 months (95% CI: 15.9–23.5) for cemiplimab plus chemotherapy versus 12.9 months (95% CI: 10.6–15.7) for chemotherapy alone (HR = 0.65, 95% CI: 0.51–0.82, p = 0.0003); median progression-free survival was 8.2 months (95% CI: 6.4–9.0) versus 5.5 months (95% CI: 4.3–6.2) (HR = 0.55, 95% CI: 0.44–0.68, P< 0.0001), and objective response rates were 43.6% versus 22.1%, respectively.
In general, the safety was consistent with previously reported data. The incidence of treatment-emergent adverse events of grade 3 or higher was 48.7% with cemiplimab plus chemotherapy compared to 32.8% with chemotherapy alone. At the protocol-specified final OS analysis after 28.4 months of follow-up, the EMPOWER-Lung 3 study continued to demonstrate the superiority of cemiplimab plus chemotherapy over chemotherapy alone in patients with advanced squamous or nonsquamous NSCLC, regardless of programmed death-ligand 1 level.
Source: sciencedirect.com/science/article/abs/pii/S1556086423001855