AVEO Pharmaceuticals Inc. (AVEO) said the previously reported results from a Phase 2 trial evaluating the efficacy and safety of tivozanib in 272 patients with advanced renal cell carcinoma were published in the Journal of Clinical Oncology. Results showed improved median progression-free survival or PFS among patients treated with tivozanib compared with placebo, and that tivozanib was well tolerated with minimal off-target toxicities, the company added.
Phase 2 trial's positive results informed the design and implementation of TIVO-1, a pivotal Phase 3 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.
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.
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