AVEO Pharmaceuticals, Inc.
Astellas Pharma, Inc.
) recently announced final overall survival (OS) results from the
phase III TIVO-1 study on tivozanib. The TIVO-1 (TIvozanib Versus
sOrafenib in 1st line advanced RCC) study was conducted in
patients suffering from advanced renal cell carcinoma (RCC).
The median OS was 28.8 months for tivozanib compared to 29.3
Onyx Pharmaceuticals, Inc.
) Nexavar (sorafenib). OS was the secondary endpoint of the
The company is currently seeking US Food and Drug
Administration (FDA) approval for tivozanib. A New Drug
Application (NDA) was submitted in Sep 2012. The FDA accepted the
application in Nov 2012 with a response expected by Jul 28,
We note that earlier, the companies had presented results
showing that tivozanib achieved a statistically significant
improvement in the primary endpoint of progression-free survival
(PFS) compared to Nexavar.
The OS data will be presented on Feb 16 at the 2013 American
Society for Clinical Oncology Genitourinary Cancers Symposium
We note that tivozanib is currently in additional programs and
studies like BATON and TAURUS, respectively. The BATON (Biomarker
Assessment of Tivozanib in ONcology) program includes studies
assessing tivozanib biomarkers in solid tumors. TAURUS (TivozAnib
Use veRsUs Sutent in advanced RCC: Patient Preference) study is
being conducted to demonstrate patient preference of tivozanib
compared to Sutent (sunitinib) as first-line therapy in patients
with advanced RCC.
Other pipeline candidates at AVEO include oncology candidates
AV-203 and ficlatuzumab.
We are pleased with the pipeline progress at AVEO. We expect
investor focus to remain on the response from the FDA for
tivozanib. Approval of tivozanib will be a major milestone for
the company. AVEO and Astellas currently carry a Zacks Rank #3
(Hold). Right now, Bayer carries a Zacks Rank #2 (Buy).
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