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Bristol-Myers' Opdivo Fails To Meet Primary Endpoint In Brain Tumor Study

Bristol-Myers Squibb Co. (BMY) said Thursday that late-stage CheckMate -548 trial evaluating the addition of Opdivo or nivolumab to the current standard of care compared to the standard of care alone did not meet one of its primary endpoints, progression-free survival, in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated.

The company noted that 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.

"Though CheckMate -548 did not show statistically significant improvement in progression-free survival, we are continuing to evaluate the benefit the addition of Opdivo to the standard of care treatment regimen may bring to patients suffering from GBM, an extremely aggressive and difficult disease to treat," said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb.

glioblastoma multiforme is the most common and most aggressive type of primary malignant tumor of the central nervous system.

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