Multinational phase 3 trial of adjuvant pembrolizumab versus placebo for completely resected stage IB-IIIA NSCLC

Pembrolizumab is a standard-of-care for advanced non-small cell lung cancer. The multinational phase 3 PEARLS/KEYNOTE-091 trial evaluated pembrolizumab as adjuvant therapy for completely resected stage IB-IIIA NSCLC. The trial included 1177 patients (not selected for PD-L1 expression) of 196 centers in 29 countries. Patients were randomized 1:1 to pembrolizumab or placebo. Median disease-free survival was significantly improved with pembrolizumab over placebo, while pembolizumab was not associated with new safety signals. The authors conclude that pembrolizumab is potentially a new treatment option for stage IB-IIIA NSCLC after complete resection and, when recommended, adjuvant chemotherapy, regardless of PD-L1 expression.