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Bristol-Myers: Phase 3 CheckMate -548 Trial Will Not Meet Primary Endpoint Of Overall Survival

Biopharmaceutical company Bristol Myers Squibb Co. (BMY) said Wednesday that following a routine review of the CheckMate -548 Phase 3 trial by an independent data monitoring committee or DMC, the company was informed that based on the number of events to date, the study will not meet its primary endpoint of overall survival in patients with no baseline corticosteroid use or in the overall randomized population.

The DMC also indicated there were no safety concerns observed in patients treated with Opdivo that warranted stopping the study.

CheckMate -548 is a Phase 3 trial evaluating the addition of Opdivo (nivolumab) to the current standard of care (temozolomide and radiation therapy) versus placebo plus the standard of care, in patients with newly diagnosed glioblastoma multiforme (GBM) with O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation following surgical resection of the tumor.

The primary endpoints of the trial are progression free survival (PFS) per blinded independent central review (BICR) in all randomized patients and overall survival (OS) in patients with no corticosteroid use at baseline as well as in all randomized patients.

The secondary endpoints are investigator assessed PFS, and OS rate at 12 and 24 months.

"We are disappointed that CheckMate -548 did not meet its desired outcome despite limiting enrollment to patients with MGMT promoter methylation, which we believed may have led to improved survival. We are grateful to the patients, caregivers and investigators for participating in this trial and will continue to work with the oncology community in the pursuit of effective therapies for patients with this difficult disease," said Michael Mandola, Oncology Development Program Lead of Bristol Myers Squibb.

Based on the recommendation of the DMC, investigators will be unblinded to the treatment assignments of patients enrolled in the study. Patients will be counseled on their treatment options, and those currently deriving benefit from Opdivo are permitted to continue treatment if agreed to with their physician.

The company will complete a full evaluation of the CheckMate -548 data and work with investigators to share the final results publicly with the oncology community.

In September 2019, Bristol-Myer said that the trial did not meet its other primary endpoint of progression-free survival in all randomized patients.

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