AVEO Oncology (AVEO) Initiates Tivozanib Phase 2 in mBC Patients
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AVEO Oncology (Nasdaq: AVEO) and Astellas Pharma Inc. announced the initiation of patient enrollment in a randomized, double-blind, multicenter Phase 2 clinical trial, called BATON-BC, evaluating the efficacy of tivozanib, an investigational drug, in combination with paclitaxel compared to placebo in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer who have received no prior systemic therapy for advanced or metastatic breast cancer (mBC). Triple negative breast cancer was selected for tivozanib clinical evaluation because of high unmet need and insights gained from AVEO’s Human Response PlatformTM indicating that these tumors are enriched for a signature of VEGF pathway deregulation similar to that seen in renal cell carcinoma (RCC). BATON-BC is the third trial to be initiated as part of the BATON (Biomarker Assessment of Tivozanib in ONcology) clinical development program, which includes ongoing trials in advanced metastatic colorectal cancer and advanced RCC.
BATON-BC, which is being led by AVEO, is a double-blind, placebo-controlled, randomized (2:1 tivozanib/placebo), multicenter study that will enroll approximately 147 patients at 50 sites worldwide. The primary endpoint of BATON-BC is progression-free survival (PFS). Secondary objectives include evaluation of objective response rate, overall survival and safety. An additional component of BATON-BC is the evaluation of biomarker relationships that may be predictive of clinical response to tivozanib in patients with triple negative breast cancer.
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/m2), 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).
BATON-BC, which is being led by AVEO, is a double-blind, placebo-controlled, randomized (2:1 tivozanib/placebo), multicenter study that will enroll approximately 147 patients at 50 sites worldwide. The primary endpoint of BATON-BC is progression-free survival (PFS). Secondary objectives include evaluation of objective response rate, overall survival and safety. An additional component of BATON-BC is the evaluation of biomarker relationships that may be predictive of clinical response to tivozanib in patients with triple negative breast cancer.
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/m2), 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).
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