More disappointment for AVEO’s tivozanib in colorectal cancer

There was yet another setback for US biotech firm AVEO Oncology (Nasdaq: AVEO) on Friday, when the company announced that its Phase II study with colorectal cancer (CRC) drug candidate tivozanib is unlikely to meet the primary endpoint in the intent-to-treat patient population. The news sent the stock down 9% to $1.71 by close of trading.

The BATON (Biomarker Assessment of Tivozanib in ONcology) study, led by Japanese partner Astellas (TYO: 4503), is an open-label, randomized Phase II trial with a primary endpoint evaluating the superiority of tivozanib in combination with modified FOLFOX6, a standard chemotherapy, 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.

Data from the planned interim analysis, including biomarker data, are being analyzed, and AVEO and Astellas are in discussions regarding next steps, the company stated. Under its deal with Astellas, based on milestone achievements this could have been worth $1.3 billion to AVEO.