It was disappointing when Bristol-Myers Squibb's (NYSE: BMY) brivanib failed to help second-line liver cancer patients in December, but hope remained that that the drug could be used as a first-line treatment.
Unfortunately, brivanib just failed there, too. We don't have too many details, but Bristol said the phase 3 trial failed to show that brivanib was non-inferior to Onyx Pharmaceuticals' (Nasdaq: ONXX) Nexavar. Being just as good as the current standard of care is a pretty low bar to set, and brivanib couldn't even accomplish that.
Brivanib is being tested in more clinical trials for liver and other cancers, and Bristol is going to have to make a decision about whether it's worth continuing the trials. My bet is that liver cancer is probably out as an indication, but that it's probably worth continuing to explore options in other cancers. Pfizer's (NYSE: PFE) Sutent works in kidney cancer but failed to show an effect in liver cancer, for example.
Assuming brivanib is dead as a treatment for liver cancer, that's good news for Onyx as well as ArQule (Nasdaq: ARQL), which is preparing to start a phase 3 trial for its oncology drug tivantinib in second-line liver cancer patients.
When Bristol handed back cabozantinib to Exelixis (Nasdaq: EXEL), many speculated it was because the pharma thought brivanib had better prospects and would rather plow its R&D dollars into it. After posting positive phase 3 data in thyroid cancer last October, cabozantinib is on the verge of Food and Drug Administration approval, and brivanib's prospects look bleak.
Bristol has generally been thought of as one of the best pharmas at making deals, packing its pipeline through acquisitions and licensing deals, and I'd tend to agree. But brivanib's failure highlights the fact that drug development often comes down to a crapshoot, and even the best sometimes fail. I wouldn't count Bristol out just yet.
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