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 Platform TM 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 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.