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.