Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced that tivozanib demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 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.

All patients in TIVO-1 had clear cell RCC, had undergone a prior nephrectomy, and had not previously been treated with either a VEGF or mTOR therapy. Based on the top-line analysis of events in TIVO-1, determined by a blinded, independent review committee, key top-line findings include:

• tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall study population
• tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 12.7 months compared to a median PFS of 9.1 months for sorafenib in the pre-specified subpopulation of patients who were treatment naïve (no prior systemic anti-cancer therapy); this subpopulation was approximately 70% of the total study population
• 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 United States and Europe in 2012, subject to final collection and analyses of all available data from the trial.

"We are very pleased by these results, especially the PFS benefit demonstrated in the treatment naïve population, which represents the most significant market opportunity for tivozanib," said Tuan Ha-Ngoc, president and chief executive officer, AVEO. "In addition, we were delighted with the favorable safety profile observed in TIVO-1. We would like to acknowledge the investigators and patients who participated in TIVO-1 for their important contributions and commitment to the treatment of patients with RCC."

The study participants continue to be observed to gather additional data for further analyses. AVEO and Astellas plan to submit detailed findings from TIVO-1 for presentation at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 1-5, 2012 in Chicago.

"We are delighted with the outcome of TIVO-1 and to be collaborating with AVEO on tivozanib at this critical juncture," said Steven Ryder, M.D., president, Astellas Pharma Global Development. "Tivozanib is an important asset to our strategy of becoming a global category leader in oncology. We look forward to working closely with our global partner AVEO on next steps for regulatory filings for RCC and advancing clinical development of tivozanib in colorectal cancer and other solid tumors."