Bristol-Myers loses to Onyx in PhIII battle of drugs for liver cancer

Bristol-Myers Squibb ($BMY) swung for the fences and whiffed. In a late-stage trial pitting its compound brivanib against Nexavar in patients with liver cancer, the drug giant's candidate failed to show non-inferiority to the marketed med. And Bristol's major miss provides a victory to Onyx Pharmaceuticals ($ONXX), the white-hot provider of Nexavar.

The disappointing Phase III BRISK-FL trial marks at least the second late-stage trial where Bristol's brivanib has failed to hit its main goal as a treatment for hepatocellular carcinoma, the most common form of liver cancer. In its release late Thursday, Bristol said that it's mulling the development plan for the drug, an experimental inhibitor of vascular endothelial and fibroblast growth factor receptors. The New York-based company expects to reveal details of the BRISK-FL study at a future scientific meeting.

It's been a rough summer for Bristol's pipeline. The FDA dealt the company and partner Pfizer ($PFE) a blow last month with the agency's Complete Response rejection of their experimental anti-clotting drug Eliquis, seeking clarification on data management and verification from a key trial for the potential blockbuster. Now Bristol must consider its options for brivanib, which is in clinical trials for a variety of cancers.

On the flip side, Onyx has been on a roll as of late. The South San Francisco-based drugmaker has seen its stock soar this summer, during which the FDA granted priority review to its and Bayer's regorafenib for colorectal cancer and buzz has built about a lucrative potential sale of Onyx. Plus, Onyx may have one less rival to its best-selling drug, Nexavar.

"While we do not find [the BRISK-FL] result overly surprising based on prior clinical data for brivanib and negative results for other competitors, we expect the news to be well received by [Onyx] investors," Cory Kasimov, a biotech analyst at J.P. Morgan, wrote in a note to investors Thursday evening. "This removes the last near-term threat to Nexavar in [liver cancer] and, as such, reinforces our view that Nexavar will remain the standard of care therapy for HCC through the balance of the decade until IP expiry in 2020."

- here's the release
- see the Wall Street Journal's article

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