We’ve been following AVEO Pharmaceuticals on Catalyst~Watch ahead of the AdCom vote today (May 2nd, 2013). The catalyst has been triggered – AVEO is down 48.3% at the time of writing.
Today, the FDA’s Oncologic Drugs Advisory Committee meeting voted 13-1 against the question on whether AVEO’s Renal Cell Carcinoma (RCC) drug had demonstrated enough benefits to outweigh the risk with clinical trial data included in its current NDA submission. The briefing documents, which go over the materials that were seen by the panel (and the public) two days ago and prior to the actual meeting, are here.
“I cannot picture how I would talk with a patient about putting him or her on tivozanib, allowing them to live without progression longer but possibly to die faster,” Mikkael Sekeres, panel chairman and associate professor of medicine staff at the Cleveland Clinic’s Taussig Cancer Institute, said during the meeting today in Silver Spring, Maryland.
More specifically, there are major concerns about the uncertain improvements that the drug demonstrates in overall survival (OS) versus comparators, as shown in the clinical trial data from Phase III trial TIVO-1
From a AVEO and partner Astellas Pharma Inc. (TSE:4503) press release from February 12th, 2013:
The final OS analysis, as specified by the protocol, shows a median OS of 28.8 months (95% confidence interval [CI]: 22.5–NA) for tivozanib versus a median OS of 29.3 months (95% CI: 29.3–NA) for the comparator arm, sorafenib. No statistical difference between the two arms (HR=1.245, p=0.105) was observed.
This is graphically displayed on Page 67 of the panel’s briefing documents:
This vote virtually guarantees that the company will receive a CRL on the PDUFA date of July 28, 2013 although AVEO and its investors are hopeful that another Phase III trial can demonstrate improvement in a tivozanib arm versus a comparable VEGF inhibitor.
In response to today’s events, JPMorgan also downgraded AVEO from a “Overweight” to a “Neutral” rating as well.
Worth noting is the fact that AVEO had a stockholder’s equity figure of $118.9 M as of December 31st, 2012 as displayed in their 10-K filings. The market’s current valuation of the company implies that the tivozanib program is worth little to nothing at this point, which may not be the case if the drug can be salvaged later on. Having said this, the overwhelmingly negative vote will keep sentiment on the stock and company extremely negative until new clinical trial data arrives.