ASCO: Results from TIVO-3

TIVO-3: Final OS analysis of a phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma (RCC)

Abstract No : 5062

Abstract Type : Poster Session

Indication : Renal Cell Carcinoma

Intervention : AVEO Oncology

Company : Merck & Co.

Technology : VEGF Tyrosine Kinase Inhibitor


The 2 arms were well balanced for demographics and prior cancer history. 60% of subjects had 2 prior lines of therapy and 40% had 3 prior lines. 26% had prior treatment with a CPI. Patients treated with T demonstrated PFS superiority compared to S, 5.6 (95% CI 7.3 - 5.3) v. 3.9 mos (95% CI 5.6 – 3.7; HR 0.73; p=0.02). ORR was 18% for T compared to 8% for S (p=0.02). 44% of T treated subjects experienced a grade 3 treatment-related adverse event compared to 55% for S. The predefined, interim analysis for OS performed two years after enrollment was closed had a HR of 0.99 based on 227 events. The final analysis will be presented based on an estimate of 263 events.


T is superior to S as measured by PFS; 2-year PFS, and ORR in this heavily-treated/ relapsed or refractory RCC population and is better tolerated than S. Final OS data will be updated prior to presentation.


Results from TIVO-3 supports tivozanib as an evidence based treatment option for patient with RCC, including for patients whose disease has progressed after previous checkpoint inhibitor (CPI) treatment.

Refer to Renal Cell Carcinoma Market report for detailed Insights.