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AVEO and Astellas Discontinue Breast Cancer Trial

Published: Friday, January 31, 2014
Last Updated: Friday, January 31, 2014
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Joint decision to discontinue trial due to insufficient enrollment.

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.

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