Updated with stock price.
CAMBRIDGE, Mass. (
) -- Final overall survival results from the phase III study of
(AVEO - Get Report)
kidney cancer drug tivozanib were released Tuesday night, and as expected, tivozanib-treated patients were at a greater risk of death than those treated with
At the median, the difference in survival was just two weeks. Tivozanib-treated patients reported a median overall survival of 28.8 months compared to 29.3 months for Nexavar patients.
However, when overall survival in the study was analyzed over two years, the relative risk of death was 25% higher in the tivozanib arm relative to the Nexavar arm. [Hazard ratio = 1.245.] While survival trended against tivozanib, the greater risk of death was not statistically significant.
Aveo has struggled for months to assuage investor concerns about the confounding results from the tivozanib study in advanced kidney cancer patients. Tivozanib met the primary endpoint of the study by delaying tumor regrowth by almost three months more than Nexavar (11.9 months vs. 9.1 months.) However, this significant improvement in progression-free survival favoring tivozanib did not help patients live longer.
Last August, shares of Aveo fell from $14 to $8 when the company first disclosed FDA's concerns about the confounding survival analysis from the tivozanib trial.
Aveo shares closed Tuesday at $7.89 but were down 11% to $7.04 in early Wednesday trading.
Aveo believes overall survival of tivozanib was snake bit by a study design that allowed patients treated initially with Nexavar to receive effective, subsequent therapy, including tivozanib. Of the 257 patients who started the study on Nexavar, 74% "crossed over" to receive treatment with other kidney cancer drugs, including tivozanib and other so-called VEGF therapies like
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By comparison, 36% of the patients treated initially with tivozanib went on to receive additional kidney cancer drugs, including 10% who received subsequent VEGF therapies.
In certain smaller subsets of patients, overall survival trended in favor of tivozanib over Nexavar, the opposite of what occurred in the study as a whole. Some of these alternate survival analyses were pre-defined in the study's statistical analysis plan, while others were not, a company spokesman said.