AVEO And Astellas Announce Initiation Of Patient Enrollment In Phase 2 Trial Of Tivozanib In Combination With Paclitaxel In Patients With Advanced Triple Negative Breast Cancer

“While tivozanib is currently under review with the FDA for advanced RCC, we’re committed to investigating the development of tivozanib beyond advanced RCC,” said Stephen Eck, M.D., Ph.D., Vice President of Medical Oncology, Astellas Pharma Global Development. “At Astellas, we are committed to discover and develop molecularly targeted therapies and precision medicines that have the potential to revolutionize the methods used to treat cancer patients.”

Data from a Phase 1b clinical trial of tivozanib (0.5 mg - 1.5 mg per day for three weeks, followed by one week off, repeating at a cycle of 28 days) in combination with weekly paclitaxel (three weeks on, followed by one week off) in patients with metastatic breast cancer demonstrated that the combination was considered tolerable at the full dose and schedule of both agents (tivozanib 1.5 mg and paclitaxel 90 mg/m ²), and resulted in an objective response rate of 38% (5/13 patients). In the study, 54% (7/13) of patients had stable disease (SD), with a median duration of SD of 8.5 months (range: 4.2–10.7). ¹

“Currently there are no approved targeted therapies for the treatment of triple negative breast cancer. Biomarkers derived from AVEO’s Human Response Platform will be evaluated for potential use in identifying breast cancer patients who will be most likely to benefit from treatment with tivozanib,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “Following the FDA’s recent acceptance of a New Drug Application seeking approval for tivozanib in advanced RCC, we remain committed to expanding the development of tivozanib in additional solid tumor types, and look forward to further evaluating tivozanib as a potential new treatment option for patients living with triple negative breast cancer.”

About Triple Negative Breast Cancer

Globally, breast cancer is diagnosed in about 1.4 million women annually and about 230,000 women annually in the United States. ²About 1 in 8 women will develop invasive breast cancer during their lifetime. ³

Triple negative breast cancer is comprised of tumors that do not express the estrogen receptor, progesterone receptor or the human epidermal growth factor receptor-2 and accounts for approximately 12-20% of breast cancers. ^2,3 Receptor expression is typically confirmed at the time of a breast cancer diagnosis. There are currently no approved targeted therapies for triple negative breast cancer.

About Tivozanib

Tivozanib is a potent, selective and long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities. Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a Phase 3 clinical study in advanced RCC have been reported, and is being evaluated in other tumors.

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