(Renal Cancer) Is Tivozanib Effective?

• March 9, 2020
• Reading time: 2 minutes

On December 3, 2019, Brian I Rini published in The Lancet Oncology the Phase 3 TIVO-3 trial results evaluating the VEGF inhibitor tivozanib monotherapy as 3rd/4th-line treatment in renal cell carcinoma (RCC) patients.

Trial Design

This Phase 3 trial randomized RCC patients with at least two prior lines of therapy in a 1:1 ratio to:

• Tivozanib monotherapy group (N=175)
• Sorafenib monotherapy group (N=175)

Primary endpoint: Progression-free survival (PFS).

Background: Multiple clinical trials had previously established the efficacy of VEGF inhibitors in RCC, including in patients with prior anti-PD-1 antibody treatment. This trial was designed to evaluate tivozanib monotherapy in this setting.

Efficacy Results

At a median follow-up of 19.0 months:

• Median PFS: Tivozanib 19.0 months / Sorafenib 3.9 months
• Tivozanib significantly reduced progression risk by 27% (HR 0.73)

Safety Profile

Most common Grade 3–4 adverse events:

• Hypertension: Tivozanib 20% / Sorafenib 14%

Serious adverse event rates:

• Tivozanib: 11% / Sorafenib: 10%

No treatment-related deaths were reported.

Conclusions

Based on TIVO-3 results, Brian I Rini concluded that tivozanib monotherapy as 3rd/4th-line treatment significantly improved PFS compared to sorafenib in RCC patients, with good tolerability.

Source: Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2019 Dec 3. doi: 10.1016/S1470-2045(19)30735-1.

Tags: #RenalCancer #Tivozanib

• Clinical trial drug

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