Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma

Eur Urol. 2020 Dec;78(6):783-785. doi: 10.1016/j.eururo.2020.08.007. Epub 2020 Sep 13.

Abstract

Tivozanib is a potent and selective inhibitor of the VEGF receptor. In an open-label, randomized phase 3 trial, we compared tivozanib to sorafenib in patients with metastatic renal cell carcinoma (mRCC) who had received two or three prior therapies. We have previously reported that the study met its primary endpoint, demonstrating an improvement in progression-free survival with tivozanib versus sorafenib (5.6 mo vs 3.9 mo; hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.56-0.94; p=0.016). The current report reflects the final assessment of overall survival, showing no difference between treatment with tivozanib and sorafenib (HR 0.97, 95% CI 0.75-1.24). Given its activity and distinct tolerability profile, tivozanib represents a treatment option for patients with previously treated mRCC. PATIENT SUMMARY: We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments. No difference in survival was observed.

Keywords: Overall survival; Sorafenib; TIVO-3; Tivozanib; VEGF inhibitor.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / mortality*
  • Carcinoma, Renal Cell / secondary
  • Female
  • Humans
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / mortality*
  • Kidney Neoplasms / pathology
  • Male
  • Phenylurea Compounds / therapeutic use*
  • Quinolines / therapeutic use*
  • Retreatment
  • Sorafenib / therapeutic use*
  • Survival Rate

Substances

  • Antineoplastic Agents
  • Phenylurea Compounds
  • Quinolines
  • tivozanib
  • Sorafenib