BMS says CheckMate -548 trial of Opdivo in glioblastoma will not meet goal

US pharma major Bristol Myers Squibb (NYSE: BMY) yesterday announced a disappointing update on its CheckMate -548, a Phase III 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.

Following a routine review of the study by an independent data monitoring committee (DMC), BMS 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 indicated there were no safety concerns observed in patients treated with Opdivo that warranted stopping the study.

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