BMS’ Opdivo misses target in aggressive brain cancer trial

It’s never good news when a drug firm posts an “update” about a phase 3 trial, and Bristol-Myers Squibb’s PR team have had to issue news of another trial disappointment from the misfiring cancer immunotherapy Opdivo.

There have been some notable successes for Opdivo (nivolumab), one of the first immunotherapies approved by the FDA in diseases including melanoma and kidney cancer, but it’s been hit and miss for the PD-1 class drug with some high profile trial failures.

The latest is from the phase 3 CheckMate-548 trial testing Opdivo against current standard of care – temozolomide and radiation therapy – in a very aggressive form of brain cancer.

BMS said that the trial in newly-diagnosed glioblastoma multiforme failed to meet one of its primary endpoints, progression-free survival.

The trial’s independent data monitoring committee recommended that the trial should continue to the other primary endpoint, overall survival, in this patient population who disease is O6-methylguanine-DNA methyltransferase (MGMT)-methylated.

In short, the trial has shown Opdivo does not stop the disease from spreading, but BMS is allowing it to continue to see if it can still extend patients’ lives in this most aggressive tumour of the central nervous system. The company remains blinded to all study data.

Fouad Namouni, BMS head of oncology development, said: “Though CheckMate-548 did not show statistically significant improvement in progression-free survival, we are continuing to evaluate the benefit the addition of Opdivo to the standard of care treatment regimen may bring to patients suffering from GBM, an extremely aggressive and difficult disease to treat. We look forward to seeing the overall survival data when they are available.”

Opdivo generated revenues of more than $1.8 billion for BMS in Q2 and is the company’s top selling drug.

But it is lagging behind Merck & Co’s arch-rival PD-1 Keytruda (pembrolizumab), which made more than $2.6 billion in Q2 alone.

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