BMS misses primary endpoint in aggressive brain cancer trial

There have been some notable successes for BMS’s drug, one of the first immunotherapies approved by the FDA in diseases including melanoma and kidney cancer, but it’s been hit and miss for the PD-1 class drug with some high profile trial failures.

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.”

Opdivo generated revenues of more than $1.8 billion for BMS in Q2 and is the company’s top selling drug.

But it is lagging behind Merck & Co’s arch-rival PD-1 Keytruda (pembrolizumab), which made more than $2.6 billion in Q2 alone.