Aveo's tivozanib finally moving forward after 4-year delay
- The first safety hurdle has been passed for Aveo Oncology's tivozanib – the Phase 3 TIVO-3 trial, looking at the drug in refractory renal cell carcinoma, has passed its first Safety Monitoring Committee (SMC) review. The committee asked that the company recruit further patients to replace dropouts, but this isn't expected to dealy the trial.
- TIVO-3 will fill in data gaps left by the earlier TIVO-1 study, which led to rejection of a New Drug Application (NDA) by the Food and Drug Administration in 2013. The agency had determined previous trials results were uninterpretable due to a faulty trial design.
- A topline readout for TIVO-3, which is testing the kidney cancer drug against Bayer/Onyx's VEGF inhibitor, Nexavar (sorafenib), is expected early 2018.
The FDA rejected Aveo's NDA for tivozanib back in June 2013, asking for further clinical testing in its complete response letter. The letter stated that the results of the TIVO-1 study in first-line treatment of RCC were inconsistent, uninterpretable and inconclusive for the risk-benefit analysis.
The safety review of TIVO-3 reported no safety concerns, and recommended replacing a number of patients who had dropped out prior to treatment. Enrollment is ahead of schedule, according to the company, and around 322 patients should be enrolled by June 2017. The company will carry out a pre-planned futility analysis in mid-2017 to look at efficacy. Aveo plans to use the results of the two studies to support a new NDA for first- and third-line use in RCC.
"We are very pleased to see the pace at which TIVO-3 is enrolling, and that it has completed its first safety review. We look forward to the futility analysis around midyear," said Michael Needle, CMO of Aveo.
Another study, a phase 1/2 trial known as TiNivo, is looking at the combination of tivozanib with Bristol-Myers Squibb's Opdivo (nivolumab), also in RCC. The first patient is expected to be treated in early March.
"Tivozanib is a unique molecule in that its high selectivity for VEGF is designed to reduce off target toxicity, thereby increasing tolerability and its combinability with other agents, such as immunotherapies," said Needle.
Last March, Aveo paid the Securities and Exchange Commission $4 million to settle charges over misleading investors over the FDA's review of tivozanib, in May 2012.
- Aveo Oncology Statement
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