Singapore: Aveo Oncology and Astellas Pharma announced overall survival (OS) for tivozanib, an investigational agent, from the phase III TIVO-1 (Tivozanib versus sorafenib in first line advanced RCC) study in patients with advanced renal cell carcinoma (RCC).

The final OS analysis, as specified by the protocol, shows a median OS of 28.8 months (95 percent confidence interval [CI]: 22.5-NA) for tivozanib versus a median OS of 29.3 months (95 percent CI: 29.3-NA) for the comparator arm, sorafenib. No statistical difference between the two arms (HR=1.245, p=0.105) was observed.

Overall survival is a secondary endpoint of the TIVO-1 study. A one-sided crossover for patients randomized to the sorafenib (comparator) arm was offered pursuant to a separate, long-term treatment protocol to allow trial participants to receive tivozanib upon disease progression. This resulted in a substantial difference in the use of subsequent therapies.

Of the patients who discontinued their initial therapy, 10 percent originally on the tivozanib arm received subsequent anti-VEGF therapy (36 percet received any subsequent therapy) while 70 percent of patients originally on the comparator arm received subsequent anti-VEGF therapy (74 percent received any subsequent therapy).

Principal investigator Mr Robert J Motzer, attending physician, genitourinary oncology service, Memorial Sloan-Kettering Cancer Center, and professor of medicine, Weill Medical College, Cornell University, New York, said that, "It's encouraging to see that patients in the study who received tivozanib had a median overall survival of 28.8 months, particularly given that these patients received minimal subsequent therapy. The safety and efficacy results from TIVO-1 and other clinical trials of tivozanib in advanced RCC suggest it may provide an important new first line treatment option for patients with this aggressive disease."