AVEO Pharmaceuticals, Inc. (AVEO) 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.
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