Bristol-Myers Squibb's Opdivo fails to hit survival goal in study of patients with newly diagnosed MGMT-unmethylated glioblastoma multiforme

Bristol-Myers Squibb said Thursday that a Phase III study evaluating Opdivo (nivolumab) plus radiation versus temozolomide plus radiation in patients with newly diagnosed MGMT-unmethylated glioblastoma multiforme (GBM) failed to meet its primary endpoint of overall survival (OS) at its final analysis. Fouad Namouni, head of oncology development, said the company is "disappointed" in the results of the CheckMate -498 trial, although he noted that GBM is "a notoriously aggressive cancer."

The study randomised patients with newly diagnosed MGMT-unmethylated GBM to receive radiation either in combination with Opdivo or temozolomide. Bristol-Myers Squibb noted that following surgery, patients in the experimental arm received Opdivo every two weeks concurrent with radiation, followed by maintenance with the PD-1 inhibitor every four weeks until disease progression or unacceptable toxicity.  

According to Bristol-Myers Squibb, the safety profile of Opdivo in the study was consistent with previous findings. The drugmaker added that data from the trial will be fully evaluated prior to future presentation and publication.

Bristol-Myers Squibb indicated that Opdivo is also being investigated in the Phase III CheckMate -548 study, in which the therapy is added to the current standard of care, radiation plus temozolomide, in patients with newly diagnosed MGMT-methylated GBM. Sales of Opdivo jumped 19 percent in the first quarter to $1.8 billion (for related analysis, see ViewPoints: Key takeaways from Bristol-Myers Squibb's Q1 earnings and investor call).

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.