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AVEO And Astellas Announce Positive Findings From TIVO-1 Superiority Study Of Tivozanib In First-Line Advanced RCC

“We believe that tivozanib may play a significant role in improving the treatment of patients with advanced kidney cancer,” stated Tuan Ha-Ngoc, president and CEO of AVEO Oncology. “Together with our partner Astellas, we look forward to the next steps in our registration process and are continuing our preparations for the planned commercialization of tivozanib.”

“Based on these data, we look forward to advancing tivozanib in kidney cancer with AVEO,” stated Steven Ryder, M.D., president, Astellas Pharma Global Development. “These data further support Astellas’ goal of leadership in oncology and our commitment to developing a world-class oncology platform based on innovative, research-driven solutions and dynamic partnerships.”

About Renal Cell Carcinoma

Advanced RCC, or kidney cancer, is the ninth most commonly diagnosed cancer in men and women in the U.S. 1 Worldwide it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from the disease each year. 2 RCC accounts for more than 90 percent of all kidney cancers. 3 Currently available therapies provide less than one year of median PFS in treatment naïve patients and are associated with significant toxicities. 4 These toxicities not only lead to high rates of dose reductions and interruptions (potentially compromising efficacy), but also can impact a patient’s quality of daily living. 5

About Tivozanib

Tivozanib is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities. Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a Phase 3 clinical study in advanced renal cell carcinoma have been reported, and is being evaluated in other tumors.

About TIVO-1

TIVO-1 is a global, randomized Phase 3 superiority clinical trial evaluating the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma (RCC). TIVO-1 is the first superiority pivotal study in first-line advanced RCC that has demonstrated statistically significant and clinically meaningful PFS superiority versus an approved targeted agent (sorafenib) in advanced RCC. The TIVO-1 study has demonstrated that a potent, selective and long-half life inhibitor of all three VEGF receptors can result in superior efficacy and improved tolerability.

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