Fotivda milestone 5-year follow-up data: efficacy beats Nexavar!

AVEO Oncology recently announced new long-term results from the Phase 3 TIVO-3 study of the targeted anticancer drug Fotivda (tivozanib) in advanced renal cell carcinoma (RCC) at the 2022 American Society of Clinical Oncology Symposium on Genitourinary Cancers (ASCO GU).

Fotivda, an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), was approved by the U.

In particular, Fotivda is the first treatment approved for the treatment of adults with relapsed or refractory advanced RCC who have received 2 or more prior systemic regimens

TIVO-3 is a randomized, active-controlled, multicenter, open-label study in 351 patients with highly refractory advanced or metastatic RCC evaluating Fotivda versus Bayer's targeted cancer drug Nexavar (Nexavar, Generic name: sorafenib, sorafenib) efficacy and safety

Previously published results showed: (1) Compared with the Nexavar treatment group, the Fotivda treatment group increased the median progression-free survival (PFS) by 44% (5.

The milestone 5-year follow-up data presented at the meeting showed that the investigators' assessment of PFS was consistent with the independent review committee's findings, with a consistently higher rate of progression-free survival (PFS) in the Fotivda arm compared to the Nexavar arm, with 3-year and 12% vs 2% and 8% vs 0% at 4 years, respectively

In addition, long-term OS was also analyzed at the meeting, which continued to show a non-significant trend (HR=0.

(Original abridged)