Bristol-Myers Squibb Announces Opdivo Glioblastoma Study Does Not Meet PFS Primary Endpoint

Bristol-Myers Squibb announced that the Phase 3 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.

"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. We look forward to seeing the overall survival data when they are available," said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. "We are grateful to the patients, caregivers and investigators participating in this trial who make this research possible."

CheckMate -548 is a Phase 3 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.

GBM is the most common and most aggressive type of primary malignant tumor of the central nervous system. The global incidence of GBM is less than 10 per 100,000 people. Standard treatment for patients with newly diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The last investigational medicine to improve survival for patients with newly diagnosed GBM was approved by the U.S. Food and Drug Administration in 2005. The five year survival rate of patients with GBM is less than five percent.

MGMT methylation status is among the most commonly used biomarkers in GBM for treatment guidance. Studies suggest MGMT methylation status may be predictive of the likelihood of patients with GBM to respond to therapy.

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