BATON-BC Trial Initiation Marks Entry into Third Tumor Type for Tivozanib Clinical Development Program

CAMBRIDGE, Mass. and TOKYO, Japan, December 3, 2012 - AVEO Oncology (NASDAQ:AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced the initiation of patient enrollment in a randomized, double-blind, multicenter Phase 2 clinical trial, called BATON-BC, evaluating the efficacy of tivozanib, an investigational drug, in combination with paclitaxel compared to placebo in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer who have received no prior systemic therapy for advanced or metastatic breast cancer (mBC). Triple negative breast cancer was selected for tivozanib clinical evaluation because of high unmet need and insights gained from AVEO’s Human Response PlatformTM indicating that these tumors are enriched for a signature of VEGF pathway deregulation similar to that seen in renal cell carcinoma (RCC). BATON-BC is the third trial to be initiated as part of the BATON (Biomarker Assessment of Tivozanib in ONcology) clinical development program, which includes ongoing trials in advanced metastatic colorectal cancer (CRC) and advanced RCC.

“While currently available chemotherapy and hormonal therapies have significantly enhanced the survival of women diagnosed with breast cancer, there remains an unmet treatment need for those fighting advanced triple negative breast cancer.” said Erica Mayer, M.D., M.P.H., director of Clinical Research, Dana-Farber/Brigham and Women’s Cancer Center at Faulkner Hospital, assistant professor in medicine, Harvard Medical School, and BATON-BC primary investigator. “The BATON-BC trial is designed to evaluate progression free survival as well as improve our understanding of triple negative breast cancer by providing us with the opportunity to identify the patients who are most likely to be responsive or resistant to tivozanib therapy.”

BATON-BC, which is being led by AVEO, is a double-blind, placebo-controlled, randomized (2:1 tivozanib/placebo), multicenter study that will enroll approximately 147 patients at 50 sites worldwide. The primary endpoint of BATON-BC is progression-free survival (PFS). Secondary objectives include evaluation of objective response rate, overall survival and safety. An additional component of BATON-BC is the evaluation of biomarker relationships that may be predictive of clinical response to tivozanib in patients with triple negative breast cancer.

“While tivozanib is currently under review with FDA for advanced RCC, we’re committed to investigating the development of tivozanib beyond advanced RCC,” said Stephen Eck, M.D., Ph.D., Vice President of Medical Oncology, Astellas Pharma Global Development. “At Astellas, we are committed to discover and develop molecularly targeted therapies and precision medicines that have the potential to revolutionize the methods used to treat cancer patients.”

Data from a Phase 1b clinical trial of tivozanib (0.5 mg - 1.5 mg per day for three weeks, followed by one week off, repeating at a cycle of 28 days) in combination with weekly paclitaxel (three weeks on, followed by one week off) in patients with metastatic breast cancer demonstrated that the combination was considered tolerable at the full dose and schedule of both agents (tivozanib 1.5 mg and paclitaxel 90 mg/m2), and resulted in an objective response rate of 38% (5/13 patients). In the study, 54% (7/13) of patients had stable disease (SD), with a median duration of SD of 8.5 months (range: 4.2–10.7).

“Currently there are no approved targeted therapies for the treatment of triple negative breast cancer. Biomarkers derived from AVEO’s Human Response Platform will be evaluated for potential use in identifying breast cancer patients who will be most likely to benefit from treatment with tivozanib,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “Following the recent submission of a New Drug Application to the FDA seeking approval for tivozanib in advanced RCC, we remain committed to expanding the development of tivozanib in additional solid tumor types, and look forward to further evaluating tivozanib as a potential new treatment option for patients living with triple negative breast cancer.” 

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