Astellas And Aveo To Discontinue Phase II Trial Of Tivozanib

Astellas Pharma and Aveo Oncology announced today that Phase 2 trial of Tivozanib, an investigational treatment for breast cancer, will be jointly discontinued by the two companies. The decision to stop the trial was made due to low patient accumulation.

Tivozanib is a once-daily, oral investigational tyrosine kinase inhibitor. It is a selective and long half-life inhibitor that retards vascular endothelial growth factor (VEGF) receptors while keeping off-target toxicities at a minimum. The Phase II of BATON (Biomarker Assessment of Tivozanib in ONcology) breast cancer clinical trial was intended for patients with metastatic triple negative breast cancer (TNBC) or locally recurrent breast cancer.

The BATON-BC trial began in December of 2012 and tested efficacy of the drug in combination with paclitaxel compared to placebo combined with paclitaxel in qualified patients who have received one systemic therapy for advanced or metastatic breast cancer. The study was a randomized, double-blind, and multi-center Phase II clinical trial. Aveo has initially announced that patient enrollment for the study had been slower than expected. Recruitment rates did not improve in any significant way after additional recruitment efforts.

“Separately, as announced in December 2013, data from a planned interim analysis of the Phase II 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,” Aveo said.

Aveo Chief Medical Officer William Slichenmyer said, “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. We want to thank the study investigators and their patients who participated in the trial for their support.”

Committed expenses generated by the study were equally shared between Aveo and Astellas.

Source:

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