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Bristol-Myers’ checkpoint star Opdivo fails a PhIII study for glioblastoma

Bristol-Myers Squibb $BMY has had another setback on the checkpoint inhibition front, though this one they can take in stride.

Fouad Namouni, Bristol-Myers Squibb

Their big drug Opdivo failed to beat out Avastin in treating recurrent glioblastoma, or brain cancer, in improving overall survival rates. Investigators are holding back the actual data for a presentation at an upcoming conference in Zurich.

Checkmate-143 was the first randomized study of a PD-1 checkpoint for glioblastoma, says Bristol-Myers, which is still pursuing two first-line GBM clinical trials, CheckMate -498 and CheckMate -548, evaluating the combination of Opdivo with radiation therapy with or without temozolomide in O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated and methylated patients.

Once the leading player in PD-1, Bristol-Myers has had to deal with bitter setbacks on the non-small cell lung cancer front, as Merck has surged past with Keytruda. But with four players now in the market, with the arrival of avelumab, all the major league developers here are scrambling forward in hundreds of studies trying combos or monotherapy for a wide range of cancers.

All of that activity seems to be ramping up with new studies every day as these companies hustle to claim their share of a multibillion-dollar market.

While Bristol-Myers acknowledged this failure, the company was also posting more positive data on Opdivo, including its 2-year overall survival data for its Yervoy combo on first-line melanoma.

“GBM is a historically difficult disease to treat and conventional treatment options have demonstrated limited responses,” said Fouad Namouni, the head of Oncology Development and head of Medical for Bristol-Myers Squibb. “We remain steadfast in our pursuit of treatments for diseases with the highest unmet need and continue our work to determine how our Immuno-Oncology agents can potentially improve outcomes for these patients.”


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