AVEO and Astellas' tivozanib beats sorafenib in Ph III TIVO-1 trial

US cancer drug developer AVEO Pharmaceuticals (Nasdaq: AVEO)) and partner Japanese drug major Astellas Pharma (TYO: 4503) say that tivozanib demonstrated superiority over sorafenib (Bayer’s already marketed Nexavar) in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase III 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 registration study in first-line RCC that is comparing an investigational agent against an approved VEGF therapy. Despite the positive findings, AVEO’s shares plunged 16.3% to $14.39 in morning trading yesterday, while the Nasdaq rose more than 2%.

Astellas acquired global rights (excluding Asia) to Aveo’s lead cancer product candidate tivozanib, in an accord that could earn a potential $1.3 billion or more for the US firm (The Pharma Letter February 17, 2011).The two companies are also developing ficlatuzumab (AV-299), an anti-HGF/c-MET antibody currently in Phase II development as a combination therapy against non-small-cell lung cancer and is undergoing earlier clinical evaluation in combination therapy against other solid tumors.