NEW YORK – Bristol Myers Squibb said on Wednesday that the addition of nivolumab (Opdivo) to standard-of-care chemoradiation has failed to extend overall survival in patients with MGMT-methylated brain cancer.
After reviewing results of the 700-patient, Phase III CheckMate-548 clinical trial, an independent data monitoring committee determined that due to the number of events recorded to date, the addition of BMS's immune checkpoint inhibitor to chemoradiation would not meet its primary endpoint of extending overall survival versus standard of care alone in patients with MGMT-methylated glioblastoma multiforme following surgical resection of their tumors. An update reported in September 2019 showed that the treatment combination did not improve progression-free survival in this difficult-to-treat patient population, but BMS moved forward with the trial in the hopes that the overall survival data would show improvement.
"We are disappointed that CheckMate-548 did not meet its desired outcome despite limiting enrollment to patients with MGMT promoter methylation, which we believed may have led to improved survival," Michael Mandola, BMS's program lead of oncology development, said in a statement. "We … will continue to work with the oncology community in the pursuit of effective therapies for patients with this difficult disease."
Although the treatment was deemed safe enough for the study to continue, investigators will now be unblinded to patients' treatment assignments, and patients will be counseled about their best treatment options, including potentially remaining on the combination therapy if they were benefitting from the nivolumab-chemoradiation regimen.
BMS will conduct a full evaluation of the CheckMate-548 data and share the final results in the future.