AVEO Oncology (NASDAQ:AVEO) announces that final results from the Phase 3 TIVO-3 study comparing Fotivda (tivozanib) to Bayer’s (OTCPK:BAYRY) Nexavar (sorafenib) in renal cell carcinoma (RCC) patients in third- and fourth-line settings were just published in the journal European Urology.
Consistent with its announcement in May, the trial met the primary endpoint demonstrating tivozanib’s superiority in extending progression-free survival (PFS) with 27% less risk of cancer progression. Specifically, median PFS in the tivozanib arm was 5.6 months versus 3.9 months in the sorafenib arm (p=0.02; hazard ratio = 0.73).
Tivozanib failed to match sorafenib in overall survival (OS), a secondary endpoint. Median OS in the tivozanib group was 16.4 months compared to 19.2 months for sorafenib. Despite the shortfall, the company states that tivozanib’s OS hazard ratio was 0.97, meaning that there was 3% less risk of death than sorafenib.
AVEO’s U.S. marketing application is currently under FDA review with an action date of March 31, 2021. No advisory committee meeting is planned.
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