CAMBRIDGE, Mass. & MILAN--(BUSINESS WIRE)-- AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) were presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy. ESMO is the leading European oncology professional organization, committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care.
“We believe these data represent a potentially significant advance in the treatment of advanced kidney cancer,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “With the recent completion of patient enrollment in TIVO-1, six months ahead of schedule, we look forward to Phase 3 data for tivozanib in advanced RCC, which we expect to obtain in mid-2011. We believe tivozanib’s promising tolerability and efficacy profile suggests the potential for broad applicability and combinability with chemotherapies and other targeted agents. We are currently evaluating tivozanib as a single-agent and in combination with approved agents in clinical trials in RCC, gastrointestinal, metastatic breast, and lung cancers. We look forward to the opportunity of continuing to collaborate with the global medical oncology community to advance these efforts.”
The Phase 2 clinical trial evaluated tivozanib in 272 patients with advanced RCC. Data showed that the median progression-free survival (PFS) achieved by patients with advanced clear cell RCC who had undergone a prior nephrectomy was 14.8 months – comparing favorably to historical data from trials testing other currently approved multikinase inhibitors in RCC. Median PFS among all 272 patients in the Phase 2 trial was 11.8 months. Hypertension was the most commonly reported treatment-related adverse effect, and was observed in 50% of treated patients. Development of hypertension was directly associated with improved clinical outcomes among patients overall and in the subset of patients with clear cell RCC who had undergone a prior nephrectomy. Off-target toxicities commonly associated with other targeted therapies, such as mucositis, fatigue and hand-foot syndrome, were notably low in the tivozanib group, which AVEO believes underscores a differentiated safety profile and potential for combinability with other therapeutic agents.
“I believe that tivozanib represents a potential therapeutic advance in the treatment of advanced kidney cancer,” said Cora Sternberg, M.D., FACP, chief of medical oncology at San Camillo Forlanini Hospital, Rome, and TIVO-1 investigator. “The efficacy and tolerability demonstrated by these Phase 2 data further highlight the role that tivozanib may play in the treatment of patients with kidney cancer and other serious cancers, as a single agent or in combination with other therapies. I am pleased to be participating in the Phase 3 TIVO-1 trial, and look forward to learning more about this much-needed potential treatment option as those data become available.”
These data were presented today by Dmitry A. Nosov, M.D., Ph.D., senior clinical researcher at the Blokhin Oncology Research Center, Moscow, Russian Federation, in an oral presentation titled, “Phase 2 Randomized Discontinuation Trial (RDT) of Tivozanib in Patients With Renal Cell Carcinoma (RCC): Results in Patients Randomized to Tivozanib vs. Placebo.”
AVEO recently completed patient enrollment in TIVO-1, a global Phase 3 clinical trial of tivozanib in patients with advanced RCC who have not received prior VEGF-targeted therapy. With patient enrollment initiated in February of this year, TIVO-1 successfully exceeded the target enrollment of 500 patients in August 2010, six months ahead of schedule.
TIVO-1 is evaluating the efficacy of tivozanib compared to sorafenib (Nexavar®), an FDA and EMA approved therapy for RCC. TIVO-1 is the first-ever Phase 3 study in RCC designed to evaluate superiority of a single agent in a head-to-head comparison against an approved anti-angiogenesis therapy in first-line RCC. The primary endpoint of the trial is to compare the progression-free survival (PFS) of tivozanib vs. sorafenib. Secondary endpoints include overall survival, objective response rate, safety and quality of life. Patients who demonstrate disease progression during treatment with sorafenib will have the opportunity to be treated with tivozanib by participating in a separate long-term treatment protocol. This trial is being led by Robert Motzer, M.D. from the Memorial Sloan-Kettering Cancer Center. Top-line data are expected mid-2011.
Tivozanib, an investigational new drug, is a highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting picomolar inhibitory activity against all three receptors. Due to its potency and specificity, AVEO believes tivozanib may enable optimal inhibition of the VEGF pathway, while minimizing side effects associated with off-target activity. Such a profile may enable tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility. The EMA has granted AVEO orphan medicinal product designation for tivozanib for the treatment of RCC.
AVEO recently completed patient enrollment ahead of schedule in TIVO-1, a global, randomized (1:1), controlled Phase 3 clinical trial evaluating tivozanib compared to sorafenib (Nexavar®) in patients with RCC. The company has initiated a series of clinical trials evaluating tivozanib in combination with other agents in multiple solid tumor settings, including an ongoing Phase 1b trial in combination with temsirolimus (Torisel®), an approved mTOR inhibitor, in patients with metastatic renal cell carcinoma; a Phase 1b trial in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers; and a Phase 1b trial in combination with paclitaxel (Taxol®) in patients with metastatic breast cancer. A Phase 1b trial evaluating tivozanib as monotherapy in patients with non-small cell lung cancer is also being conducted.
AVEO is also utilizing its Human Response Platform™ in its efforts to help identify rational drug combinations and patient populations most likely to be responsive to these combination therapies.
AVEO Pharmaceuticals (NASDAQ: AVEO) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company’s lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with a highly differentiated profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR. For more information, please visit the company's website at www.aveopharma.com.
Any statements in this press release about our future expectations, plans and prospects, including statements about tivozanib’s potential to advance treatment of advanced kidney cancer; the timing of receipt of top-line data from TIVO-1; our continued collaboration with the global medical oncology community; the advancement of tivozanib toward potential regulatory approval; tivozanib’s potentially tolerable safety profile and potential for broad applicability and combinability with other therapeutic agents; the role tivozanib may play in the treatment of cancer;; our cancer biology platform offering a unique advantage in oncology drug development, and other statements containing the words "believes," "anticipates," "plans," "expects," “will” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for tivozanib and our other product candidates; the possibility that favorable data from our Phase 2 clinical trials of tivozanib may not be predictive of the results in TIVO-1 and our other clinical trials; delays in data availability, or negative results from TIVO-1; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
AVEO Pharmaceuticals, Inc.
Monique Allaire, 617-299-5810
Caton Lovett, 910-232-7166
KEYWORDS: United States Europe North America Massachusetts Italy
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical