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CRC Treatment Likely To Miss Endpoint

Aveo, Astellas post interim analysis of Ph II study

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Aveo Oncology has posted data from a planned interim analysis of the Phase II study of tivozanib in patients with colorectal cancer (CRC). The data indicate that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.

The trial, led by development partner Astellas, is an open-label, randomized Phase II 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 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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