A total of 616 patients were randomized to receive frontline pembrolizumab or placebo in combination with chemotherapy. After a median follow-up of 10.5 months, overall survival rate was higher in the pembrolizumab group than the placebo group (69.2% vs. 49.4%; hazard ratio for death=0.49, P<0.001). The survival benefit was observed across all PD-L1 categories that were examined, including those with PD-L1 expression < 1%. Median progression-free survival was also superior in the pembrolizumab group (8.8 vs. 4.9 months). Grade ≥ 3 adverse events rate was similar in both groups (67.2% vs. 65.8%); however, acute kidney injury was more frequent in the pembrolizumab group (5.2% vs 0.5%). This study may suggest a new standard of care in metastatic non-squamous NSCLC without EGFR or ALK mutations.
Gandhi, L. et al. N. Engl. J. Med.