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Bristol-Myers' Opdivo fails to halt disease progression in brain cancer patients

Bristol-Myers Squibb Co. said its blockbuster immunotherapy Opdivo failed to improve the time brain cancer patients lived without their disease getting worse in a clinical trial.

Results from a phase 3 trial dubbed CheckMate -548 showed that Opdivo, or nivolumab, did not meet one of its main goals called progression-free survival — a measure to see how well a cancer therapy works.

The study evaluated Opdivo in addition to chemotherapy drug temozolomide and radiation therapy — the current standard of care — versus the standard of care alone in patients with newly diagnosed brain cancer that is O6-methylguanine-DNA methyltransferase methylated. Temozolomide is sold by Merck & Co. Inc. as Temodar.

The trial's data monitoring committee recommended the study continue as planned to see results on another primary goal, overall survival or the length of time from either diagnosis or start of treatment that a patient lives, the New York-based drugmaker said.

Glioblastoma multiforme is the most common and most aggressive type of tumor that originates within the brain, for which there are limited treatment options available. About 10 in 100,000 individuals are diagnosed with the disease worldwide. The last investigational drug to improve survival for patients with newly diagnosed glioblastoma multiforme was approved by the U.S. Food and Drug Administration in 2005.

Opdivo is one of Bristol-Myers' top-selling drugs, recording about $1.82 billion in sales during the second quarter. Opdivo is already approved for treating certain types of melanoma, renal cell carcinoma and lung cancer.