Better outcomes with combination therapy of nivolumab plus gemcitabine-cisplatin in untreated advanced urothelial carcinoma

According to a recent study, combination therapy with nivolumab plus gemcitabine-cisplatin yielded significantly better outcomes in patients with previously untreated advanced urothelial carcinoma when compared to gemcitabine-cisplatin alone. This study’s findings were published in The New England Journal of Medicine.

This phase 3, multinational, open-label trial included 608 patients with previously untreated unresectable or metastatic urothelial carcinoma. They were randomly assigned to receive either 360mg of intravenous nivolumab plus gemcitabine-cisplatin (nivolumab combination) every 3 weeks for up to 6 cycles, and later on, 480mg nivolumab every 4 weeks for a maximum of 2 years or gemcitabine-cisplatin alone every 3 weeks for up to 6 cycles. The primary outcomes of the study were overall and progression-free survival.

At the median follow-up of 33.6 months, it was observed that with nivolumab-combination therapy (21.7 months), overall survival was longer than with gemcitabine-cisplatin alone (18.9). Similarly, progression-free survival was also longer with nivolumab-combination therapy at 7.9 months compared to 7.6 months with gemcitabine-cisplatin alone (hazard ratio for progression or death,0.72; 95% Cl, 0.59 to 0.88; P = 0.001). At the end of one year, the progression-free survival was 34.2% for nivolumab-combination therapy and 21.8% for gemcitabine-cisplatin alone.

From the above findings, it can be concluded that combination therapy with nivolumab plus gemcitabine-cisplatin may result in significantly better outcomes in patients with previously untreated advanced urothelial carcinoma.