The phase 3 CheckMate 498 trial, designed to compare Opdivo with Temodal for the treatment of patients with newly diagnosed O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma multiforme failed to meet its primary endpoint of increasing overall survival.
The phase 3 CheckMate 498 trial, designed to compare Opdivo (nivolumab) with Temodal (temozolomide) for the treatment of patients with newly diagnosed O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma multiforme (GBM) failed to meet its primary endpoint of increasing overall survival at final analysis, according to Bristol-Myers Squibb – the drug’s manufacturer.
“While we are disappointed the CheckMate -498 trial did not meet its primary endpoint, GBM is a notoriously aggressive cancer,” Dr. Fouad Namouni, head of oncology development at Bristol-Myers Squibb, said in a company-issued release. “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.”
In the randomized, multicenter phase 3 CheckMate -498 study, patients received either:
- Opdivo, after surgery, every two weeks concurrent with radiation, followed by maintenance with Opdivo every four weeks until disease progression or excessive toxicity; or
- Temodal plus radiation.
Overall survival served as the primary endpoint of the study, while secondary endpoints included progression-free survival and overall survival rate at two years.
The safety profile of Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, was consistent with previously reported studies in solid tumors. Bristol-Myers Squibb plans to complete a full evaluation of the data from the trial and work with investigators on the future presentation and publication of the results, the release said.
Opdivo is also being studied in patients with newly diagnosed MGMT-methylated GBM in other clinical trials, including the phase 3 CheckMate 548 study – designed to evaluate the addition of Opdivo to radiation plus Temodal, which is the current standard of care.