Tivozanib Shows Efficacy and Safety in Heavily Pretreated ccRCC

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EP: 1.Tivozanib Shows Efficacy and Safety in Heavily Pretreated ccRCC

EP: 2.Discussing Tolerability of Tivozanib as Third-Line Therapy for mRCC

EP: 3.Reviewing Efficacy and Tolerability in TIVO-3 Trial of Tivozanib for RCC

EP: 4.Second-Line Considerations After Immune Toxicity From Prior RCC Therapy

EP: 5.Factors Favoring Tivozanib as Third-Line Therapy for Advanced RCC

EP: 6.Lenvatinib/Everolimus Vs Tivozanib Evaluated for Later-Line RCC

EP: 7.Factors for Selecting Later-Line Therapies in Advanced RCC

EP: 8.Discussing the Role of Tivozanib in the Third-Line of RCC Treatment

EP: 9.Use of Immunotherapy Considered in Later Lines of RCC Therapy

EP: 10.Choosing Between Tivozanib and Lenvatinib/Everolimus in Third-Line RCC

EP: 11.Integrating Tivozanib into Treatment of Advanced RCC

EP: 12.Hammers and Participants Discuss AEs Associated with TKIs in RCC

EP: 13.Navigating Third-Line Treatment in R/R Metastatic RCC

EP: 14.Assessing Second- and Third- Line Therapies in Advanced RCC

EP: 15.Sequencing Choices from First- to Third-Line Regimens in ccRCC

EP: 16.Key Efficacy and Tolerability Factors for Later-Line Therapies in RCC

EP: 17.Peers Discuss Impressions of Tivozanib’s Role as Third-Line RCC Therapy

EP: 18.Tolerability Concerns Influence Use of Lenvatinib/Everolimus Vs Tivozanib in RCC

EP: 19.Tolerability Helps Decide Third-Line Treatment in Advanced RCC

EP: 20.Long-Term Durability Favors Tivozanib Vs Other TKI in Recurrent mRCC

EP: 21.The Field of Recurrent RCC Regimens Continues to Grow

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.

TRANSCRIPTION:

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.