Brian Rini, MD
The VEGF inhibitor tivozanib (Fotivda) reduced the risk of disease progression or death by 26% compared with sorafenib (Nexavar) in patients with highly refractory advanced or metastatic renal cell carcinoma (RCC), according to topline findings from the phase III TIVO-3 trial.
In the trial, which enrolled patients who had received ≥2 prior lines of therapy, the median progression-free survival was 5.6 months with tivozanib, compared with 3.9 months with sorafenib (HR, 0.74; P
= .02). The overall response rates were 18% versus 8%, respectively (P
Overall survival (OS) data were not mature at the time of the final PFS analysis; however, the preliminary OS analysis did not show a statistically significant OS difference between the treatment arms (HR, 1.06; P
= 0.69). AVEO Oncology, the manufacturer of tivozanib, plans to report additional TIVO-3 data at a future medical meeting. The company also intends to submit a new drug application to the FDA based on the TIVO-3 results, as well as data from the phase III TIVO-1 trial of tivozanib in frontline RCC.
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