AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

Oct 4 2010

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) will be presented at the Ninth International Kidney Cancer Symposium (IKCS) in Chicago, Illinois, October 1-2, 2010. Additionally, data from an ongoing Phase 1b trial evaluating tivozanib in combination with temsirolimus (Torisel®), an approved mTOR inhibitor, in patients with RCC will be presented at the meeting.

“A growing body of evidence suggests that tivozanib is highly differentiated in its ability to potently and selectively target VEGF, which may result in favorable tolerability, increased combinability and extended median progression-free survival in patients”

"The Kidney Cancer Association has made tremendous strides in their effort to improve the treatment and care of patients living with kidney cancer, and we are honored to have the opportunity to share tivozanib clinical data with key constituents of the kidney cancer community," said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. "We believe that there is an urgent need for a differentiated kidney cancer therapy with strong efficacy and favorable tolerability, and we look forward to continued collaboration with the Kidney Cancer Association, clinicians and patients as we make efforts to advance tivozanib toward regulatory approval."

The Phase 2 clinical trial evaluated tivozanib in 272 patients with advanced RCC. Data showed that the median 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. 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 potential tolerable safety profile and potential for combinability with other therapeutic agents.

"A growing body of evidence suggests that tivozanib is highly differentiated in its ability to potently and selectively target VEGF, which may result in favorable tolerability, increased combinability and extended median progression-free survival in patients," said Thomas E. Hutson, D.O., Pharm.D., Baylor University Medical Center, Sammons Cancer Center, Dallas, and the co-primary investigator for TIVO-1, AVEO's Phase 3 tivozanib trial in advanced kidney cancer. "TIVO-1, the first-ever Phase 3 study in RCC designed to evaluate superiority in a head-to-head comparison against a widely prescribed anti-angiogenesis therapy in first-line treatment, has been designed to equip oncologists with the information necessary to make the most appropriate treatment decisions for their patients battling kidney cancer."

Results from a Phase 1 clinical study evaluating tivozanib in combination with the mTOR inhibitor temsirolimus (Torisel), a rapamycin pro-drug, in patients with advanced kidney cancer will be presented in an oral session by Fairooz Kabbinavar, M.D., professor of medicine and urologic oncology, Henry Alvin and Carrie L. Meinhardt chair in Kidney Cancer Research, director, Hematology-Oncology Fellowship Program, medical director, Thoracic Oncology and Kidney Cancer Programs, David Geffen School of Medicine, University of California, Los Angeles. Study results showed tumor shrinkage in 12 out of 16 patients evaluated, and two partial responses as assessed by RECIST criteria. The combination was well-tolerated with no dose limiting toxicities (DLT).

Murray Robinson, Ph.D., senior vice president, translational medicine at AVEO, will also be making a presentation titled, "Tivozanib: clinical progress and response biomarkers," highlighting AVEO's ongoing tivozanib clinical research efforts, and the company's commitment to exploring how protein biomarker research may help clinicians determine optimal treatment combinations for patients battling kidney cancer and other tumor types.

"Understanding how predictive biomarkers fit into the kidney cancer landscape, and how they may help inform optimal treatment decisions for patients, is new and exciting ground for us in the oncology medical community," added Dr. Hutson. "I applaud AVEO's research efforts, and the company's goal of further advancing our understanding of how biomarkers may ultimately improve the treatment and care of patients living with kidney cancer."