Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer

Abstract (PubMed)

In this open-label, phase 3 trial, 305 patients with previously untreated advanced NSCLC with PD-L1 expression ≥50% of tumor cells and no EGFR mutation or ALK translocation were randomized to pembrolizumab (200 mg every 3 weeks) or platinum-based chemotherapy. Crossover was permitted on disease progression. The primary endpoint was progression-free survival (PFS) assessed by blinded central radiologic review. Median PFS was 10.3 months (95% CI 6.7-NR) with pembrolizumab versus 6.0 months (95% CI 4.2-6.2) with chemotherapy (HR 0.50; 95% CI 0.37-0.68; P<0.001). Overall survival was also improved (HR 0.60; 95% CI 0.41-0.89; P=0.005 for interim analysis). Pembrolizumab significantly improved PFS in previously untreated PD-L1-high NSCLC.