AVEO Pharmaceuticals, Inc.
) and partner
Astellas Pharma, Inc.
) announced their decision to discontinue a phase II study
evaluating tivozanib in patients suffering from locally recurrent
or metastatic triple negative breast cancer. The companies
decided to end the phase II BATON (Biomarker Assessment of
Tivozanib in ONcology) breast cancer (BC) study due to
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The randomized, double-blind, multi-center phase II BATON BC
study was initiated in Dec 2012 to compare the efficacy of
) Taxol (paclitaxel) with Taxol plus placebo in locally recurrent
or metastatic triple negative breast cancer patients, who have
not received or received one systemic therapy.
In its third quarter 2013 press release, AVEO had disclosed that
the enrolment process for the phase II BATON BC study was slower
than expected. Despite patient recruitment efforts, enrollment
rates did not improve significantly.
This is the latest in tivozanib-related setbacks for AVEO. Last
month, AVEO and Astellas had announced that data from a planned
interim analysis of the phase II BATON- CRC (colorectal cancer)
study on tivozanib revealed that the study was unlikely to meet
the primary endpoint.
Prior to that, in June last year, the companies had received a
complete response letter (CRL) from the U.S. Food and Drug
Administration (FDA) for tivozanib for advanced renal cell
carcinoma (RCC). The FDA had informed AVEO that the new drug
application (NDA) was not approvable in its present form.
Following the CRL, AVEO decided to discontinue tivozanib
development for the advanced RCC indication.
AVEO's shares have plunged more than 75% over the last one year.
Given the disappointing news related to tivozanib, we expect the
shares to continue to fall further. We expect the company to
increase its focus on other pipeline candidates including AV-203
(phase I - solid tumor).
AVEO carries a Zacks Rank #3 (Hold). Some better-ranked stocks
) carrying a Zacks Rank #1 (Strong Buy).