AVEO Oncology today announced that AVEO and Astellas Pharma Inc. have jointly decided to discontinue the BATON ( Biomarker Assessment of Tivozanib in ONcology ) breast cancer clinical trial, a Phase 2 study in patients with locally recurrent or metastatic triple negative breast cancer (TNBC), due to insufficient enrollment. AVEO previously announced that enrollment in this study had been slower than anticipated, and enrollment rates did not improve substantially following additional patient recruitment efforts.
“While we believe in the potential benefits of tivozanib for patients with triple negative breast cancer, we have decided to discontinue the trial because of low patient accrual,” stated William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “We want to thank the study investigators and their patients who participated in the trial for their support.”
The BATON - BC study initiated patient enrollment in December 2012 in a randomized, double - blind, multicenter Phase 2 clinical trial, evaluating the efficacy of tivozanib 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 more than one systemic therapy for advanced or metastatic breast cancer. All committed expenses related to the BATON - BC study are shared equally between AVEO and Astellas.
Separately, as announced in December 2013, data from a planned interim analysis of the Phase 2 study of tivozanib in patients with colorectal cancer indicate that the study is unlikely to meet the primary endpoint in the intent - to - treat patient population. Interim data are being evaluated, and AVEO and Astellas are in discussions regarding next steps.