Aveo Oncology and Astellas Pharma reported positive new safety and tolerability data from the Phase III Tivo-1 trial evaluating tivozanib as first-line therapy for metastatic renal cell carcinoma (RCC). The 517-patient study comparing sorafenib with tivozanib therapy showed that patients treated with oral tivozanib stayed on their medication for longer, exhibited fewer Grade 3 and off-target adverse events, and required fewer dose reductions and interruptions. Tivozanib is currently under regulatory review in the U.S.

Efficacy data from Tivo-1 were presented earlier this year and demonstrated that tivozanib therapy resulted in statistically longer progression-free survival compared with sorafenib therapy, both in the overall patient population and among patients who were previously treatment naive.

Aveo signed a worldwide deal with Astellas Pharma in Feburary 2011 to develop and commercialize tivozanib outside Asia for the treatment of a range of cancers. The drug, which is Aveo’s lead candidate, is a selective, long half-life inhibitor of all three VEGF receptors. Subject to regulatory clearance, Aveo will head commercialization of the drug in North America, and Astellas will lead commercialization in the EU.

“Our tivozanib development program in RCC is comprehensive and ongoing,” states William Slichenmyer, M.D., Aveo’s CEO. “Additional analyses from our ongoing biomarker program will be presented at future congresses and our Taurus patient preference study vs. Sutent™ (sunitinib) is now underway.”

Aveo and Astellas are in addition conducting clinical trials evaluating tivozanib as combination therapy with other targeted therapies or chemotherapy in patients with RCC, breast, and colorectal cancers. The Baton program is a series of clinical trials initiated by Aveo and Astellas to assess tivozanib biomarkers in solid tumors. In December 2011 an open-label, multicenter, randomized Phase II Baton-CRC clinical trial was initiated, to evaluate tivozanib in combination with modified FOLFOX6 (mFOLFOX6), compared with bevacizumab in combination with mFOLFOX6, as first-line therapy in patients with advanced metastatic colorectal cancer (CRC). Baton-RCC, a Phase II exploratory biomarker study in patients with advanced RCC,was initiated during early 2011.

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