ONXX Onyx Pharmaceuticals, Inc. (MM)

AVEO Pharmaceuticals, Inc. (AVEO) and Astellas Pharma, Inc. (ALPMY) 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 months for Bayer (BAYRY) / Onyx Pharmaceuticals, Inc.’s (ONXX) Nexavar (sorafenib). OS was the secondary endpoint of the study.

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, 2013.

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 (ASCO GU).

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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