- Tivozanib as third- or fourth-line therapy improved PFS and showed a favorable safety profile vs sorafenib in patients with refractory metastatic renal cell carcinoma (RCC).
- PFS benefit was maintained in patients previously treated with checkpoint inhibitors.
- PFS was not significantly different in poor-risk patients.
Why this matters
- Low incidence of class-related toxicities and PFS advantage support tivozanib in this setting.
- Multinational phase 3 TIVO-3 trial of 350 patients (median age, 63 years) with refractory metastatic RCC were randomly assigned to receive tivozanib (n=175) or sorafenib (n=175).
- Funding: AVEO Oncology.
- Median follow-up was 19.0 months.
- Median PFS was significantly longer with tivozanib (5.6 vs 3.9 months; HR, 0.73; P=.016) vs sorafenib.
- PFS benefit was maintained in a patient subgroup that previously received checkpoint inhibitors (7.3 vs 5.1 months; HR, 0.55; P=.028).
- PFS was not significantly different in poor-risk patients (HR, 1.15; 95% CI, 1.8-3.5).
- In the tivozanib vs sorafenib group:
- The most common grade 3-4 treatment-related adverse event was hypertension (20% vs 14%).
- The serious treatment-related adverse event rate was 11% vs 10%.
- No treatment-related deaths were reported.
- Open-label design.