AVEO Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript

During this call, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements about AVEO's future expectations and plans, clinical development and regulatory timeline, the potential success of our product candidates and financial projections. These statements involves risks and uncertainties, which are described in the Risk Factors section of our most recent Form 10-Q filed with the SEC and available online at www.sec.gov.

While these forward-looking statements represent our views as of today, they should not be relied upon as representing our views in the future. We may update these statements in the future, but we are not taking on an obligation to do so.

With that, let me pass the call over to Tuan.

Tuan Ha-Ngoc

Thank you, Monique, and thank you, all, for joining us this morning. The first half of the year was quite productive for AVEO. While this call closely follows our last one in June during ASCO, Let me ask Bill to review the key results from TIVO-1 with you. Bill?

William J. Slichenmyer

Thanks, Tuan. In the TIVO-1 trial, tivozanib achieved a statistically significant improvement in PFS in the overall patient population, meeting the primary endpoint of the trial. In these patients, tivozanib had a medium PFS of 11.9 months compared to 9.1 month for sorafenib. In those patients, who were treatment naïve, tivozanib demonstrated a statistically significant improvement in PFS with 12.7 months compared to 9.1 for sorafenib. Among pivotal studies in treatment-naive patients to date, tivozanib has demonstrated the longest PFS.

Tivozanib demonstrated a favorable tolerability profile as illustrated by the significantly lower rates of dose interruptions and reductions for those patients taking tivozanib compared with sorafenib, as well as low rates of the 3 most concerning adverse events for patients treated for RCC, fatigue, diarrhea and hand-foot syndrome. We've also reported early data on overall survival, which are not yet mature, and the mediums have not yet been reached. The estimated overall survival rate at one year was 81% among patients randomized to the sorafenib arm 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 them received tivozanib after sorafenib. In comparison, only 17% of patients randomized to tivozanib went on to receive a subsequent therapy.

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