Tivozanib Shows Efficacy and Safety in Heavily Pretreated ccRCC


Helen H. Moon, MD, discusses the results of the TIVO-3 trial of tivozanib for patients with recurrent clear cell renal cell carcinoma.

Helen H. Moon, MD, principal investigator with the Cancer Clinical Trials Access Program in the Southern California Permanente Medical Group, research lead for melanoma, regional medical oncology lead for genitourinary cancer, and hematologist/oncologist at Kaiser Permanante Riverside Medical Center, discusses the results of the TIVO-3 trial (NCT02627963) of tivozanib (Fotivda) for patients with recurrent clear cell renal cell carcinoma (ccRCC).

The phase 3 TIVO-3 trial randomly assigned patients with ccRCC who had failed 2 or 3 prior systemic regimens 1:1 to receive tivozanib or sorafenib (Nexavar). The primary end point was progression-free survival (PFS). The trial met this end point with a hazard ratio of 0.73 favoring tivozanib for PFS, with a median PFS of 5.6 months versus 3.9 months with sorafenib (95% CI, 0.56-0.94; P = .016). The objective response rate (ORR) was 18% for tivozanib versus 8% with sorafenib at the primary analysis.

In terms of tolerability, patients who were heavily pretreated showed no unexpected adverse events (AEs). The most common AE was hypertension, which Moon says is a class effect of tyrosine kinase inhibitors (TKIs) and is thought to be on-target, indicating that this is a potent TKI.


0:08 | TIVO-3 is a positive study against an active comparator; in this case, it's sorafenib. So about 350 patients were randomized in 1:1 fashion. And the primary end point, which is PFS, was met. The hazard ratio was 0.73, with a significant confidence interval and ORR about [18%], which is nearly a doubling of the response rate for sorafenib.

What it showed is that even in this heavily pretreated group of patients—most of them are third line, some of them are fourth-line therapy—that they held up relatively well, with no unexpected serious AE. The most commonly seen AE is hypertension, which we believe is on-target hit of this class of medication and demonstrating tivozanib is likely a very potent TKI.

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