publication date: Feb. 7, 2014


CL40-06d.html

Drug Development
Tivozanib Trial Discontinued Due to Insufficient Enrollment


AVEO Oncology and Astellas Pharma Inc. discontinued a phase II study of tivozanib in locally recurrent or metastatic triple-negative breast cancer due to insufficient enrollment.

According to a December 2012 press release describing the initiation of the trial, named BATON-BC, it would have evaluated a combination of tivozanib and paclitaxel, compared to paclitaxel and placebo, in patients who had received no prior systemic therapy for advanced or metastatic breast cancer.

AVEO planned to enroll approximately 147 patients across 50 sites, with a primary endpoint of increasing progression-free survival. The trial would also have evaluated biomarkers related to clinical response.

BATON-BC is the third in a series of disappointing tivozanib trials, which tested the drug in advanced renal cell carcinoma and metastatic colon cancer.

In May 2013, the FDA’s Oncologic Drug Advisory Committee voted 13-1 that tivozanib did not demonstrate a favorable risk-benefit profile in the treatment of advanced RCC (The Cancer Letter, May 3, 2013).

The following month, FDA decided not to approve the company’s new drug application, stating inconsistent progression-free and overall survival results, and recommended that AVEO conduct an additional study in advanced RCC. The Securities and Exchange Commission has subpoenaed documents and information concerning the company’s application.

In December 2013, AVEO announced that a phase II study in metastatic colorectal cancer would be unlikely to reach its primary endpoint in the intent-to-treat population, following an interim analysis. BATON-CRC evaluated the superiority of tivozanib in combination with modified FOLFOX6, compared to bevacizumab in combination with modified FOLFOX6, as a first-line treatment.

Continue reading 40-06 Drug Development
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