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AVEO Pharmaceuticals, Inc. (AVEO)
June 11, 2013 8:00 am ET
David B. Johnston - Chief Financial Officer and Principal Accounting Officer
Tuan Ha-Ngoc - Chief Executive Officer, President and Director
William J. Slichenmyer - Chief Medical Officer
Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division
Salveen J. Richter - Canaccord Genuity, Research Division
Adnan S. Butt - RBC Capital Markets, LLC, Research Division
Michael G. King - JMP Securities LLC, Research Division
Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division
Previous Statements by AVEO
» AVEO Pharmaceuticals' CEO Hosts Discussion of Strategic Restructuring Conference (Transcript)
» AVEO Pharmaceuticals Management Discusses Q1 2013 Results - Earnings Call Transcript
» AVEO Pharmaceuticals' Management Presents at Barclays Global Healthcare Conference (Transcript)
David B. Johnston
Thank you, operator, and thank you, all, for joining us this morning. With me today is Tuan Ha-Ngoc, our President and Chief Executive Officer; and Bill Slichenmyer, Chief Medical Officer. Let me remind everyone that certain matters discussed today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about AVEO's future expectations, plans and prospects, financial projections, clinical development and regulatory timelines and the potential approval and success of our product candidates. These statements involve important risk and uncertainties, including those that are described in the risk factors section of our most recent Form 10-Q filed with the SEC and available online at sec.gov. While these forward-looking statements represent our views as of today, these should not be relied upon as representing our views in the future. We may update these statements in the future but I'm not taking on an obligation to do so. So with that, I will now turn the call over to Tuan.
Thank you, Dave. As we announced yesterday, we have recently received the Complete Response letter or CRL from the FDA for the application of tivozanib for the treatment of advanced RCC. While it is not surprising, given the position of the FDA doing our ODAC panel last month, we are still disappointed that the FDA did not approve our application. We continue to believe that tivozanib has been demonstrated to be a safe and effective treatment option for kidney cancer. Overall, we think this is the last of patients that would have been helped by tivozanib.
Let me now pass the call to Bill.
William J. Slichenmyer
Thanks, Tuan. In the Complete Response letter, as well as at ODAC, the primary concern was the overall survival or OS trend in our pivotal trial, which favored the control arm, sorafenib. We continue to believe that the significant difference in the use of the second-line therapies, particularly the very high use of colozenib in the control arm following sorafenib caused this trend.
Speaking briefly to the second deficiency mentioned in the Complete Response letter on the dissolution for tivozanib, the registration lots provided in our NDA meet the tighter specifications as stated by the FDA. We have the necessary data to support the change in this solution specifications. This will be reflected in our next filing and can be met for our commercial lots. Ultimately, this could have been addressed before the PDUFA date and we do not believe this was an obstacle for our approval.
Focusing then on the overall survival trend noted in the Complete Response letter. In 2 early conversations with the FDA during meetings in 2008 and 2009, both prior to initiation of the TIVO-1 study, the FDA and AVEO acknowledged that overall survival in our pivotal trial would be compounded by the subsequent use of anticancer therapies just as it has been in other RCC pivotal trials. We did not expect that to be an impediment to approval, any more than it had been in these earlier studies.
As it turned out, the extent of compounding was flagged as a concern by the FDA and was the focus of discussion at our ODAC meeting last month. We believe that the compounding of overall survival in TIVO-1 was due both to the impact of the echo comparator [ph] and the imbalance in the use of second-line therapies. In other words, as we stated at ODAC, we believe that the patients who survived longer in the control arm did so because the majority of patients received 2 drugs in succession instead of a single drug.
We enabled patients in the TIVO-1 study who are randomized to the control group to receive tivozanib as a second-line therapy after their cancer continue to progress on sorafenib. This kind of protocol is often referred to as a one-way crossover. This one-way crossover was described in a companion protocol to our TIVO-1 study, which we submitted to the FDA in September 2009. AVEO did not receive feedback from the FDA on the companion protocol, which is not uncommon. We, likewise, received no comments on this element of our protocol when we submitted it to other regulators around the world. For these reasons, we were surprised by the intensity of the criticism regarding the crossover at ODAC.
We decided to offer tivozanib as a second-line therapy following sorafenib with the best of intentions. Consistent with our belief in the benefit that tivozanib could bring to all RCC patients, it was our and the investigator's conclusion that making tivozanib available in this way was the right thing to do for patients participating in the trial. All prior first-line pivotal trials and RCC, such as those for sorafenib, sunitinib and pazopanib, included a one-way crossover to the investigational drug as part of their design and went on to receive FDA approval. The big difference between those other trials and TIVO-1 was that our trial used an active comparator in the first line instead of placebo or alpha interferon.