publication date: Jan. 10, 2014


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Drug Development

AVEO’s Tivozanib Fails In Colorectal Cancer

AVEO Oncology said that data from a planned interim analysis of the phase II BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer indicate that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.

BATON-CRC, led by Astellas, is an open-label, randomized phase II study with a primary endpoint evaluating the superiority of tivozanib in combination with modified FOLFOX6, compared to bevacizumab in combination with modified FOLFOX6 as first-line treatment in patients with advanced metastatic CRC.

A component of the BATON-CRC study is the assessment of biomarker relationships that may be predictive of response in select, pre-defined patient subpopulations.

The company said data from the planned interim analysis, including biomarker data, are being analyzed, and AVEO and Astellas are in discussions regarding next steps.

AVEO’s co-founders include MD Anderson President Ronald DePinho and his wife Lynda Chin, a senior scientist at MD Anderson. In 2012, DePinho touted the company’s stock in an appearance on a CNBC program for investors.

FDA has since rejected AVEO’s application for the renal cell carcinoma indication, and SEC has subpoenaed the company’s records.

DePinho has left the AVEO board of directors, but Chin remains on the scientific advisory board. DePinho has apologized for having offered investment advice.

Recently, Forbes columnist Matthew Herper placed AVEO on a “wall of shame” for what he described as failure to “disclose their data that made it evident what a big problem them FDA would have with them, and then walked into an FDA advisory … Continue reading 40-02 AVEO Trial

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