Multinational phase 3 trial of nivolumab plus gemcitabine-cisplatin in advanced urothelial carcinoma

A multinational phase 3 trial randomized patients with previously untreated unresectable or metastatic urothelial carcinoma to receive intravenous nivolumab 360 mg plus gemcitabine-cisplatin every three weeks for up to six cycles, followed by nivolumab 480 mg every four weeks for a maximum of two years (nivolumab group; n=304) or to receive gemcitabine-cisplatin every three weeks for up to six cycles (control grouo; n=304). The primary outcomes were overall and progression-free survival. At a median follow-up of 33.6 months, median OS was longer in the nivolumab group than in the control group (21.7 months versus 18.9 months (HR 0.78; p=0.02), as was median PFS (7.9 months versus 7.6 months; HR 0.72; p=0.001). Grade 3 or higher adverse events occurred in 61.8% and 51.7% of the patients, respectively. The authors conclude that addition of nivolumab to first-line gemcitabine-cisplatin resulted in significantly better OS and PFS.