Patients with refractory metastatic renal cell carcinoma (mRCC) have better outcomes when treated with tivozanib compared with sorafenib, according to study findings presented at the 2019 Genitourinary Cancers Symposium.

In the TIVO-3 phase 3 trial ( Identifier: NCT02627963), which compared the drugs in patients with mRCC who had received 2 or 3 prior systematic therapies that failed, median progression-free survival (PFS) was 5.6 months (95% CI, 7.3-5.3) among patients who received tivozanib compared with 3.9 months (95% CI, 5.6-3.7) for patients treated with sorafenib, lead investigator Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute in Ohio, reported. Tivozanib treatment was associated with a significant 27% decreased risk of disease progression (hazard ratio 0.73; P =.02) compared with sorafenib therapy. In addition, the PFS rate at 2 years was higher in the tivozanib compared with the sorafenib arm (18% vs 5%). Furthermore, tivozanib-treated patients had a higher objective response rate compared with sorafenib recipients (18% vs 8%).

Grade 3 treatment-related adverse events occurred in 44% of patients in the tivozanib group and 55% of the sorafenib arm. In addition, a smaller proportion of patients in tivozanib group required a dose reduction compared with the sorafenib group (24% vs 38%) or interruption of treatment (48% vs 63%) due to an adverse event. Tivozanib-treated patients also were less likely to discontinue treatment (21% vs 29%).

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The 2 treatment arms were well balanced for demographics and prior cancer history, the investigators noted. Of the entire cohort, 60% of patients had 2 prior lines of therapy and 40% had 3 prior lines. In addition, 28% had prior treatment with a checkpoint inhibitor.


Rini BI, Pal SK, Escudier B, et al. TIVO-3: A phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC). Data presented at: 2019 Genitourinary Cancers Symposium; San Francisco, CA; February 14-16. Abstract 541.