AVEO Pharmaceuticals, Inc. (AVEO: Quote) and Astellas Pharma Inc. (ALPMY.PK, ALPMF.PK) Tuesday said that tivozanib Phase 3 clinical trial demonstrated superiority over sorafenib in the primary endpoint of progression-free survival in patients with advanced renal cell carcinoma.
TIVO-1, a global, randomized Phase 3 clinical trial evaluated the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma. TIVO-1 is the first registration study in first-line renal cell carcinoma that is comparing an investigational agent against an approved VEGF therapy.
The companies noted that tivozanib demonstrated a well-tolerated safety profile consistent with the Phase 2 experience; the most commonly reported side effect was hypertension, a well established on-target and manageable effect of VEGFR inhibitors
Based on these data, AVEO and Astellas currently plan to submit for marketing approval of tivozanib in the US and Europe in 2012.
by RTT Staff Writer
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