Bristol-Myers Squibb’s blockbuster immunotherapy Opdivo (nivolumab) has hit a hurdle, failing its primary endpoint in a Phase 3 trial investigating its efficacy in the treatment of newly diagnosed O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma multiforme (GBM).

Data from the trial revealed that the drug, when used in combination with radiation, did not sufficiently improve overall survival (OS). However, Opdivo’s safety profile was found to be consistent with previous studies.

"While we are disappointed the CheckMate -498 trial did not meet its primary endpoint, GBM is a notoriously aggressive cancer," commented Dr Fouad Namouni, Head, Oncology Development at Bristol-Myers Squibb. "We are grateful to all those who participated in this trial and remain committed to researching the potential of immunotherapy to address the important unmet medical need of patients who suffer from this devastating disease."

The company has said that it plans to fully evaluate the trial data and will present and publish its results in full in the future. The drug is also undergoing investigation in combination with radiation plus temozolomide for newly diagnosed MGMT-methylated GBM.

Matt Fellows

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