Phase III CheckMate -548 trial of Opdivo fails endpoint

5 September 2019

The Phase III CheckMate -548 trial evaluating the addition of Bristol-Meyers Squibb’s (NYSE: BMY) blockbuster cancer immunotherapy Opdivo (nivolumab) to the current standard of care (temozolomide and radiation therapy) versus the standard of care alone did not meet one of its primary endpoints, progression-free survival (PFS), in patients with newly diagnosed glioblastoma multiforme (GBM) that is O6-methylguanine-DNA methyltransferase (MGMT)-methylated.

The data monitoring committee recommended that the trial continue as planned to allow the other primary endpoint, overall survival (OS), to mature. The company remains blinded to all study data.

Adds to earlier failure

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