Tivozanib improves long-term progression-free survival (PFS), when compared with sorafenib, in patients with relapsed or refractory metastatic renal cell carcinoma (mRCC), according to researchers.1

These findings, from an exploratory analysis of the TIVO-3 trial, were presented at IKCS North America 2022.

The phase 3 trial (ClinicalTrials.gov Identifier: NCT02627963) included 350 patients with relapsed or refractory mRCC who were randomly assigned to receive tivozanib (n=175) or sorafenib (n=175).

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In a prior analysis, at a median follow-up of 19.0 months, PFS was significantly longer with tivozanib than with sorafenib.2 The median PFS was 5.6 months and 3.9 months, respectively (hazard ratio [HR], 0.73, 95% CI 0.56–0.94; P =.016).

For the current exploratory analysis, researchers assessed long-term PFS and long-term overall survival (OS) up to 48 months.1 With this extended follow up, PFS was still superior with tivozanib (HR, 0.624; 95% CI, 0.49-0.79).

At various time points, the PFS rates were consistently higher with tivozanib than with sorafenib. The 36-month PFS rates were 12.3% with tivozanib and 2.4% with sorafenib. The 48-month PFS rates were 7.6% and 0%, respectively.

The researchers observed subgroups of patients with 36-month PFS rates of 15% or higher only in the tivozanib arm. These included:

  • Patients with favorable-risk disease — 17.1% with tivozanib vs 0% with sorafenib
  • Women — 17.5% vs not estimable
  • Patients with an ECOG performance status of 0 — 16.0% vs 3.2%
  • Patients age 65 and older — 15.3% vs not estimable
  • Patients living in North America — 16.5% vs not estimable.

The researchers reported that OS data continued to mature with longer follow-up. They observed a nonsignificant trend favoring tivozanib (HR, 0.89; 95% CI, 0.70-1.14).

The researchers concluded that patients treated with tivozanib were more than 5 times more likely to experience long-term PFS than patients who received sorafenib. A “clinically relevant” minority of patients from the tivozanib arm were alive and progression-free at 3 and 4 years, the team added.

Disclosures: This research was supported by AVEO Oncology. The study authors did not provide disclosures.


  1. Atkins MB, Verzoni E, Escudier BJ, et al. Long-term PFS from TIVO-3: Tivozanib (TIVO) vs sorafenib (SOR) in relapsed/refractory (R/R) advanced RCC. Presented at IKCS North America 2022. November 4-5, 2022. Abstract 33.
  2. Rini BI, Pal SK, Escudier BJ, et al. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): A phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2020;21(1):95-104. doi: 10.1016/S1470-2045(19)30735-1