Phase III CheckMate -548 trial of Opdivo in glioblastoma multiforme fails to meet primary endpoint

Bristol-Myers Squibb announced that the Phase III CheckMate -548 trial evaluating the addition of 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.

CheckMate -548 (NCT02667587) is a Phase III randomized, multi-center study evaluating Opdivo in addition to the current standard of care (temozolomide and radiation therapy), versus the standard of care alone, in patients with newly diagnosed GBM that is MGMT-methylated. The primary endpoints of the trial are PFS per blinded independent central review (BICR) and OS. The secondary endpoints are investigator assessed PFS, and OS rate up to two years.