Aveo Oncology's ($AVEO) long-troubled tivozanib is unlikely to meet its primary endpoint in a study on colorectal cancer, the company said, sending the biotech back to the drawing board after a high-profile failure in kidney cancer.
In a Phase II study led by partner Astellas, Aveo's VEGF blocker is going head to head with Avastin as a first-line treatment in patients with advanced metastatic colorectal cancer, but after an interim analysis, things aren't looking good. Tivozanib isn't on track for success in the 252-patient study, and the partners are now in the midst of "discussions regarding next steps," Aveo said in a statement.
The latest trouble is salt in tivozanib's still-fresh wounds after a resounding FDA rejection over the summer. The drug's Phase III data on renal cell carcinoma was "uninterpretable," regulators said, pushing Aveo further down a spiral that has pilloried its shares by about 80% and spurred it to lay off 62% of its workers. Astellas washed its hands of tivozanib's kidney program as a result and the partners have since regrouped to focus on the drug's potential in colorectal and breast cancers.
Now, with its odds in colorectal cancer looking bleak, tivozanib's last hope lies in triple-negative breast cancer, and Aveo and Astellas are still plugging away at a 147-patient Phase II trial comparing the drug to placebo. Aveo is leading that study, now underway for about a year, with a primary endpoint of improving in progression-free survival.
The biotech's shares dipped another 16% on the latest announcement, hitting $1.60 on Friday morning. Most of the damage to Aveo's value has long since been done, however, as an FDA panel's springtime rebuke of tivozanib cleaved about $400 million off the company's market cap in just a few days, sending its stock price down about 72%.
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