I understand tivozanib met the study's primary endpoint by demonstrating a statistically significant progression-free survival (PFS) benefit. And I also know FDA has approved other kidney cancer drugs based on PFS. But overall survival is the gold standard measurement of efficacy for cancer drug trials and tivozanib has significant issues based on these data. It's not like kidney cancer patients are lacking effective treatments today -- Sutent, Votrient, Avastin and Nexavar are all approved and in wide use.
A few more controversies in the tivozanib data to point out:
Here's another overall survival chart, this one breaking out only the patients from North America and Western Europe:
Tivozanib performs best here, demonstrating a 50% reduction in the risk of death compared to Nexavar and a strong two-year survival trend -- not statistically significant. Still, I expect Aveo likes this survival chart the best, particularly since it's seeking approval in the U.S. and Europe.But take a look at the number of patients in this analysis. Yes, there were only 40 patients out of 517 enrolled in North America and Western Europe.
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