Updated results of TIVO-1 study of tivozanib in Renal Cell Carcinoma - 07-Aug-2012

Aveo Pharma and Astellas reported detailed data from TIVO-1 (Tivozanib Versus Sorafenib in 1st line RCC), a global, randomized, Phase III, superiority clinical trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced Renal Cell Carcinoma (RCC). The data showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, and tivozanib demonstrated favorable tolerability as evidenced by a significantly lower rate of dose interruptions and reductions as compared to sorafenib.

Key data reported from TIVO-1 based on independent radiological reviews 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 (Intent To Treat) study population (HR=0.797, 95% CI 0.639-0.993; P=0.042). Objective response rate (ORR) for tivozanib was 33% compared to 23% for sorafenib (p=0.014).

Overall survival (OS) data from TIVO-1 are not yet mature and medians have not been reached. Estimated OS rate at one year was 81% among patients randomized to the sorafenib arm and and 77% among patients randomized to tivozanib. However, as reported at ASCO, 53% of patients randomized to the sorafenib arm of the trial went on to receive subsequent therapy, nearly all of whom received tivozanib after sorafenib. In comparison, only 17% of patients randomized to tivozanib went on to receive a subsequent therapy.

The FDA has expressed concern regarding the OS trend in the TIVO-1 trial and has said that it will review these findings at the time of the NDA filing as well as during the review of the NDA.