Final overall survival data from ORIENT-11 trial of first-line sintilimab plus chemotherapy for advanced nonsquamous NSCLC

The phase 3 ORIENT-11 study, in 47 centers in China, randomized patients with previously untreated locally advanced or metastatic nonsquamous NSCLC, without known EGFR or ALK alterations, to sintilimab (anti-PD-1) plus pemetrexed-platinum chemotherapy or placebo plus pemetrexed platinum-chemotherapy. The median OS was 24.2 months in the sintilimab-pemetrexed-platinum group versus 16.8 months in the placebo-pemetrexed-platinum group HR 0.65; 95% CI 0.50-0.85). OS benefit with sintilimab across all prespecified subgroups was largely consisten with that in the ITT population. The authors conclude that addition of sintilimab to chemotherapy was associated with improved OS in this patient population.