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.
In the course of our discussions with the FDA, the agency has expressed concern regarding the OS trend and has said that it will review the findings at the time of the NDA filing, as well as during the review of the NDA. They're conducting additional analyses to be included in the NDA submission that demonstrate that the OS data from TIVO-1 are consistent with improved clinical outcomes in RCC patients receiving more than one line of therapy, Analyses that we believe, will directly address this issue. We are continuing to work towards submitting the NDA by the end of the third quarter. However, there is a chance that the additional OS analyses may cause the submission to slip into the fourth quarter.We remain confident in our data supporting tivozanib and first-line RCC and believe that tivozanib represents an important new treatment option for patients with kidney cancer. To further establish the potential for tivozanib, we announced the TAURUS study designed to demonstrate patient preference of tivozanib compared to sunitinib as first-line therapy. We also expect to initiate a breast cancer study with tivozanib later this year. Let me now pass the call back to Tuan. Tuan Ha-Ngoc Thanks for that update Bill. Turning to ficlatuzumab. In May, we reported preliminary PFS findings from our exploratory Phase II study, evaluating ficlatuzumab in combination with gefitinib versus gefitinib monotherapy in previously untreated patients with advanced non-small cell lung cancer. The trial did not meet its end point in the overall population. The data is still maturing and more detailed findings on this study has been accepted for our presentation at ESMO in September. We expect to provide additional information regarding our plans in support of further development of ficlatuzumab at that time. Read the rest of this transcript for free on seekingalpha.com