Tivozanib Matches Nexavar on Cancer Survival Rate

Astellas and Aveo Pharmaceuticals have announced that the overall survival (OS) data for their kidney cancer drug, tivozanib, which demonstrates that it matches a key competitor.

Two-year data from the TIVO-1 clinical study shows that there is no statistically significant difference in the overall survival rate for tivozanib and Bayer/Onyx’s Nexavar, with both treatments providing a benefit of around 29 months.

The future of tivozanib has been under scrutiny since one-year OS data from the clinical trial suggested that it might not be as effective as Nexavar, the principal first-line therapy for advanced renal cell carcinoma (RCC).

With the primary measure in the study, progression-free survival, tivozanib was superior to Nexavar, with a considerably better progression-free survival of 8.4 months and a response rate of 13%.  The clinical trial was the first to directly compare two of the newer first-line therapies.

Aveo and Astellas have always upheld that patient crossover in the study distorted the efficacy results in favour of Nexavar, while tivozanib has a superior safety and tolerability profile than Bayer and Onyx’s treatment.  In TIVO-1 the rate of patients needing dose reductions as a result of side effects were 14% for tivozanib in comparison to 44% for Nexavar.

The US FDA is due to deliver their decision on the product by July 28th and have confirmed that they intend to assemble an advisory committee meeting to review the drug, which is likely to take place sometime after April.


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