Home Kidney Trial Watch: Aveo Oncology’s Tivozanib Reveals Positive Results for Advanced Renal Cell...

Trial Watch: Aveo Oncology’s Tivozanib Reveals Positive Results for Advanced Renal Cell Carcinoma Treatment


As reported in Specialty Pharmacy Times by Jennifer Barrett, AVEO Oncology’s investigational treatment for renal cell carcinoma (RCC) improved progression-free survival (PFS) and reduced risk of death in patients with high refractory advanced or metastatic disease as reported in recent data released from their phase 3 clinical trial.  

Tivozanib (Fotivda), AVEO Oncology’s oral, once-daily vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), was designed to optimize VEGF blockage while minimizing off-target toxicities. The treatment is approved in the EU for adult patients with advanced RCC. It is being investigated for several tumor types including hepatocellular, colorectal and breast cancers. In this most recent TIVO-3 trial, AVEO Oncology evaluated tivozanib compared with sorafenib in 351 patients with RCC who have failed at least two prior regimens, with the primary endpoint of demonstrating a statistically significant benefit in PFS. Approximately 26 percent of the patients in the trial received checkpoint inhibitor therapy in previous lines of treatment.

The clinical sponsor reported a 44 percent improvement in median PFS and 26 percent reduction in risk of progression or death (Hazard Ration HR=.74, p=0.02). Patients treated with tivozanib experienced a median PFS of 5.6 months compared with 3.9 months for sorafenib. The study also showed that median PFS for tivozanib was longer among patients who received prior checkpoint inhibitor therapy and those who did not.

Lead Research/Investigator

Brian Rini, MD, professor of medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and director of Cleveland Clinic Genitourinary Cancer Program



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