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Later-Line Therapy for Renal Cell Carcinoma: Tivozanib Versus Sorafenib

By: Nahae Kim, MPH
Posted: Thursday, January 16, 2020

In third-line or fourth-line setting for patients with metastatic renal cell carcinoma, the VEGFR tyrosine kinase inhibitor tivozanib appears to yield superior outcomes when compared with the current standard of care, sorafenib. According to recent findings from the phase III TIVO-3 clinical trial, published in The Lancet Oncology, tivozanib improved progression-free survival and tolerability for patients with renal cell carcinoma refractory to both checkpoint inhibitor treatment and two VEGFR tyrosine kinase inhibitor therapies.

“This agent has shown in clinical trials to be effective in delaying cancer growth beyond established standards for patients who have returning kidney cancer,” stated co-lead study author Sumanta K. Pal, MD, of the Kidney Cancer Program at City of Hope in Duarte, California, in a City of Hope press release. Brian I. Rini, MD, of Cleveland Clinic Taussig Cancer Institute, co-led the study with Dr. Pal.

Across 120 centers in 12 different countries, 350 patients with metastatic renal cell carcinoma with a history of at least 2 previous systemic treatments were randomly assigned to receive either tivozanib or sorafenib. Tivozanib was administered at 1.5 mg orally once daily in 4-week cycles, and sorafenib was administered at 400 mg orally twice daily continuously.

With a 19-month median follow-up period, progression-free survival was significantly longer with tivozanib (5.6 months) than sorafenib (3.9 months). The objective response rate was higher in the tivozanib group as well (18% vs. 8%).

Treatment-related adverse events were reported in 84% of patients taking tivozanib and in 94% of patients taking sorafenib, with the most common grade 3 or 4 adverse event reported being hypertension. However, dose interruptions were less frequent in the tivozanib group. Although neither treatment group had adverse events attributable to death, several patients discontinued treatment due to malignant neoplasm progression and fatigue.

Disclosure: For full disclosures of the study authors, visit thelancet.com.



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