Bristol’s Opdivo Stumbles On Its Way To First-Line Bladder Cancer Indication

The CheckMate-901 trial failed on one of its primary endpoints, but the company will continue the trial to explore additional primary endpoints.

BMS will continue a Phase III pivotal trial of Opdivo in first-line bladder cancer after a primary endpoint setback • Source: Shutterstock

Bristol Myers Squibb Company’s PD-1 inhibitor Opdivo (nivolumab) is no closer to moving into the frontline bladder cancer setting where competitors are already well-established after a pivotal trial failed to meet one of its primary endpoints. However, the company still is soldiering on in developing Opdivo for urothelial carcinoma despite this latest setback, marking the second time recently that the drug has failed to make headway in the disease.

BMS said 16 May that the CheckMate-901 trial of Opdivo plus CTLA4 inhibitor Yervoy (ipilimumab) versus chemotherapy in first-line untreated, unresectable or metastatic urothelial carcinoma (UC) did not meet the...

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