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.

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.

European urology. 2020 Sep 13 [Epub ahead of print]

Sumanta K Pal, Bernard J Escudier, Michael B Atkins, Thomas E Hutson, Camillo Porta, Elena Verzoni, Michael N Needle, Daniel Powers, David F McDermott, Brian I Rini

Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA., Department of Oncology Medicine, Gustave Roussy Cancer Campus, Villejuif, France., Department of Medical Oncology, Georgetown Lombardi University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA., Urologic Oncology, Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX, USA., Department of Internal Medicine, University of Pavia Chief, Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy., Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy., AVEO Oncology, Boston, MA, USA., Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA., Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA. Electronic address: .