AVEO Oncology (NASDAQ: AVEO) today announced that data from a planned interim analysis of the Phase 2 BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer (CRC) 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 2 study 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.
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