Bristol-Myers Squibb Co BMY, which is prepping for its purchase of Celgene Corporation CELG, announced Thursday that its cancer immunotherapy drug Opdivo failed in a late-stage study evaluating it as a brain cancer treatment.
Primary Endpoint Not Met
Bristol-Myers Squibb said the Phase 3 study dubbed CheckMate-498 that evaluated Opdivo plus radiation versus temozolomide plus radiation in patients with newly diagnosed O6-methylguanine-DNA methyltransferase-unmethylated glioblastoma multiforme — a form of brain tumor — did not meet the primary endpoint of overall survival at final analysis.
Yet the pharma giant said the treatment combo candidate's safety profile was consistent with previously reported studies in solid tumors.
"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," Fouad Namouni, the head of Bristol-Myers Squibb's oncology department, said in a statement.
Opdivo is being approved for multiple indications — including skin, lung, renal and kidney cancer — as a monotherapy as well as a combo treatment. It is also in development for several indications.
In its recently reported first-quarter release, the company said Opdivo fetched sales of $290 million, up 19 percent year-over-year. This represented a slowdown from the 33-percent growth in the fourth quarter of 2018, when it fetched sales of $443 million.
What's Next
Bristol-Myers said Opdivo is also being studied in combination with the current standard of care, radiation and temozolomide, in newly diagnosed MGMT-methylated GBM in the Phase 3 CheckMate-548 study. The primary completion date for the study is February 2022.
Bristol-Myers shares were down 1.18 percent at $46.89 at the time of publication Thursday.
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