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Bristol-Myers’ Opdivo fails in Phase 3 glioblastoma test

  • Bristol-Myers Squibb said a late-stage Opdivo study showed the medicine failed to prolong overall survival in patients with a type of newly diagnosed brain cancer.
  • The Phase 3 trial compared Opdivo with the chemotherapy agent temozolomide in patients with glioblastoma who were also receiving radiation.
  • Opdivo had a similar safety profile in CheckMate-498 to that seen in other studies, Bristol-Myers said in a Thursday news release.

Glioblastoma is notoriously hard to treat. The cancer, which claimed the lives of Sens. Ted Kennedy and John McCain, is also very aggressive. The National Cancer Institute says most patients survive for less than two years.

Bristol-Myers said it’s not giving up on the possibility that an immunotherapy can succeed where other cancer treatments have fallen short over the years. Researchers will keep trying “to address the important unmet medical need of patients who suffer from this devastating disease,” Fouad Namouni, head of oncology at Bristol-Myers, said in the May 9 release.

The company plans to release the results of another Phase 3 glioblastoma study in the second half of 2019, according to a January investor presentation.

In total, Bristol-Myers detailed 16 studies it expects to release in 2019 and 2020 for Opdivo (nivolumab) and another cancer medicine called Yervoy (ipilimumab).

Glioblastoma differs from other cancers in that therapies must get across the blood-brain barrier, designed to protect the brain from toxins. Scientists are just beginning to understand how immunotherapies do their work in the brain, according to the National Cancer Institute.

There have been some glimmers of hope. A small study published in February found a survival benefit for Merck & Co.’s Keytruda (pembrolizumab) in patients with recurrent, operable glioblastoma.

Opdivo is one of the main growth drivers for Bristol-Myers, chalking up sales of $1.8 billion in the first quarter. The checkpoint inhibitor class also includes Keytruda and rivals from Roche, Pfizer and AstraZeneca.

Bristol-Myers said it will work with researchers to determine how to present and publish the results of the latest study.