AVEO And Astellas Announce New Data Presented At ESMO 2012 Congress Demonstrating The Safety And Tolerability Profile Of Tivozanib In Patients With Advanced Kidney Cancer

AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced new data from the Phase 3 TIVO-1 trial ( TIvozanib Versus s Orafenib in 1 ^st line advanced RCC) demonstrating the safety and tolerability profile of tivozanib versus sorafenib in the first line setting for patients with metastatic renal cell carcinoma (RCC). Results presented at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria show that patients treated with tivozanib experienced fewer Grade 3 and off-target adverse events (AEs), stayed on treatment longer, and required fewer dose reductions and interruptions compared with those treated with sorafenib. ¹ Also presented were the first tivozanib biomarker data in RCC, and the design of the TAURUS ( Tivoz Anib Use ve Rs Us Sunitinib in advanced renal cell carcinoma) patient preference study, in which the first patient has now been enrolled. AVEO recently submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for tivozanib.

“Minimizing toxicities associated with anti-VEGF therapy is a vital consideration in RCC. Adverse events have been shown to contribute to dose reductions, interruptions and discontinuations of anti-VEGF therapy,” said Timothy Eisen, Ph.D., FRCP, study investigator, Cambridge University Health Partners. “The data from TIVO-1 show that treatment with tivozanib led to fewer side effects and lower rates of dose modifications than with sorafenib. This suggests that it is easier to maintain full dose therapy with tivozanib.”

The TIVO-1 global, randomized Phase 3 clinical trial compared the safety and tolerability of tivozanib and sorafenib in 517 patients with advanced RCC. Results of the trial were presented at the ASCO Annual Meeting earlier this year and showed that tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS) compared with sorafenib in the overall patient population (median PFS 11.9 months versus 9.1 months; p=0.042, HR=0.797). Further, in a pre-specified subset of RCC patients who were treatment-naïve, tivozanib demonstrated a statistically significant improvement in PFS with a median of 12.7 months compared with 9.1 months for sorafenib (p=0.037; HR=0.75), making tivozanib the first treatment to demonstrate a median PFS of greater than one year in this patient population. ² Tivozanib is an investigational drug being evaluated for first-line treatment of advanced RCC.

Title: Detailed Comparison of the Safety of Tivozanib Versus Sorafenib in Patients with Advanced/Metastatic Renal Cell Carcinoma (mRCC) from a Phase 3 TrialDate/Poster/Location: Oct. 1, 1:00-2:00pm CET / 7:00-8:00am ET; Poster #795PD; Hall F2

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