AVEO: The Adcom Meeting to Watch Next Week Print
By Staff and Wire Reports   
Tuesday, 23 April 2013 07:43
A catalyst is rapidly approaching for AVEO Pharmaceuticals (NASDAQ: AVEO) and its flagship drug tyrosine kinase inhibitor tivozanib, which will have its NDA for the renal cell carcinoma (RCC) indication reviewed and voted on by the FDA Oncologic Drugs Advisory Committee (ODAC) on May 2nd 2013. The vote is generally expected to be positive, based on the decent clinical trial data that the drug has provided in a recent pivotal Phase III trial and on the FDA’s increased lenience on cancer drugs in recent years.

The recently presented Phase III data demonstrated in a population of 517 RCC patients that the tivozanib was better tolerated than another kidney cancer drug known as sorafenib, which is marketed by Onyx Pharmaceuticals (NASDAQ: ONXX) under the trade name Nexavar. Although the data suggests that tivozanib is no better than sorafenib in terms of efficacy (if not worse), a few problems may have arose due to the specific Phase III trial’s design.

As discussed thoroughly in a recent article by Scott Matusow, the market’s initial concern with the overall survival (OS) data which made the trial fail a secondary endpoint overlooked the crossover in the trial from the Nexavar arm to the tivozanib arm for patients that saw progression in RCC. Although there are no definitive answers due to the structuring of the trial, there is reason to believe that the OS of 28.8 months in the tivozanib arm versus the 29.3 months in the Nexavar arm can be put aside for the favorable outcome we saw in progression free survival (PFS) as well as the safety of tivozanib with the new dose schedule.

While we don’t have the briefing materials for the upcoming ODAC meeting, it seems likely that this particular issue will be addressed as they attempt to justify tivozanib’s place alongside the other angiogenesis inhibitors. While these types of drugs all target the same physiologic pathways, they have certain “quirks” that make some better than others for particular types of cancer. AVEO and its investors believe that tivozanib, which inhibits all three receptors (VEGFR-1, VEGFR-2, and VEGFR-3), will be a useful option for oncologists treating RCC patients that fail to respond to other drugs in its class.

Although the FDA does not have to agree with the overall vote that will be given on tivozanib’s NDA the market will be quite confident in FDA approval if the vote is panel seems satisfied with the drug’s clinical utility, and recommends an approval. This paves the way for AVEO to receive $1.3 billion in milestone revenues from its parent company Astellas, and for the company to appreciate significantly in value.

The commercial success seems less certain due to the possibility that tivozanib may stay as a second-line treatment for RCC, although there is always potential for the company to expand into other indications. Phase II programs already exist for tivozanib in particular types of breast and colorectal cancers, and it seems that the company will be able to develop a solid tumor program based on existing data. This could shield the company (to some extent) from the market’s wrath in the event that tivozanib has a weak launch into the RCC indication, although we would likely have to wait until 2014 before seeing any hint on the market potential of AVEO’s new drug.

The Takeaway:

Expect an apparent reaction from the market after the advisory committee vote (with emphasis on the discussion over tivozanib’s efficacy), and some likely volatility between the advisory committee vote on May 2nd 2013 and the PDUFA action date of July 28, 2013. If the advisory committee believes that the VEGF inhibitor established non-inferiority versus drugs of its class, an FDA approval should be expected.

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