AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced that previously reported results from a successful Phase 2 clinical trial evaluating the efficacy and safety of tivozanib in 272 patients with advanced renal cell carcinoma (RCC) were published in the Journal of Clinical Oncology. The article, entitled, "Antitumor activity and safety of tivozanib (AV-951) in a Phase 2 randomized discontinuation trial in patients with renal cell carcinoma," is featured in the current online edition of the journal. Results demonstrated improved median progression-free survival (PFS) among patients treated with tivozanib compared to placebo, and that tivozanib was well tolerated with minimal off-target toxicities .
The positive results of this Phase 2 trial informed the design and implementation of TIVO-1, a pivotal Phase 3 clinical study in advanced RCC demonstrating tivozanib superiority over sorafenib in the primary endpoint of PFS in the first-line setting, top-line data from which were reported in January 2012.
“Current RCC therapies are associated with toxicities that can interfere with patients’ treatment regimens and impact treatment efficacy and activities of daily living,” said Dmitry A. Nosov, M.D., Ph.D., senior clinical researcher at the Blokhin Oncology Research Center, Moscow, Russian Federation, lead author of the Phase 2 study and TIVO-1 investigator. “Despite recent progress in treating patients with RCC, patients and physicians would benefit from a new RCC treatment option that delivers both improved efficacy and a more tolerable safety profile. The combined tivozanib efficacy and safety data demonstrated in this Phase 2 study supports tivozanib as a potential advancement in the RCC treatment landscape.”
Based on the positive Phase 2 data and success of the TIVO-1 trial, AVEO and its collaborator Astellas Pharma Inc. are moving forward with plans for submitting the tivozanib NDA in RCC in the third quarter of 2012, with the MAA submission to follow.