AVEO Oncology announced today that the Phase 3 TIVO-3 Trial of tivozanib in metastatic kidney cancer has met its primary endpoint.
More Favorable Tolerability Profile
Tivozanib is a tyrosine kinase inhibitor similar to other therapies already approved for RCC (such as Sutent, Inlyta and Votrient). However, this drug has a better favorability profile and many patients find it to have lower side effects. In a previous trial, Tivozanib showed superior results over sorafenib, but due to a fatal flaw in the trial design, the drug was turned down by the FDA, leaving U.S. patients without access to the drug. The drug is already approved for patients in Europe. These trial results signal that it could soon be available for patients in the U.S.
First and Only Positive Phase 3 Study in Third- and Fourth-Line RCC
The TIVO-3 trial is the first ever study of a drug for patients in later line therapies, so it gives us important information about how TKIs perform following treatment with either other TKIs or with immunotherapy regimens. Given the lower toxicity profile, this could be an excellent new opportunity for patients who have already failed multiple treatments.
Goal to Submit NDA in Approximately Six Months
While the primary endpoint of progression free survival was met, the company is still waiting on data for overall survival to become available. However, it’s expected that the data will be available soon allowing for application to the FDA in early 2019.
What does this mean for the future?
If approved as monotherapy, tivozanib could give patients who have exhausted other therapy options a new tool to combat their disease. More importantly, given the favorable side-effect profile, tivozanib could become an important therapy option in combination trials with checkpoint inhibitors.
The full press release from AVEO is available here.
To read our previous interview with Mike Atkins about TIVO-3, click here.