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BMS' Opdivo falls short at Phase 3 in glioblastoma multiforme

Published on 05/09/19 at 02:25pm

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy Opdivo (nivolumab) fell short of its primary Phase 3 endpoint in the treatment of newly diagnosed glioblastoma multiforme (GBM) when combined with the current standard of care, temozolomide and radiation therapy).

The manufacturer revealed that its combo failed to show adequate benefit in progression-free survival (PFS) in patients with GBM that is O6-methylguanine-DNA methyltransferase (MGMT)-methylated, compared to standard of care alone.

Despite the failure, BMS confirmed that the trial would continue under recommendation from the data monitoring committee in order to allow data to mature and meet its other primary endpoint of overall survival.

“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,” commented Dr Fouad Namouni, Head of Oncology Development at Bristol-Myers Squibb. “We are grateful to the patients, caregivers and investigators participating in this trial who make this research possible.”

Matt Fellows

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