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Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib:
Kathryn E Beckermann1, Aviva G Asnis-Alibozek2, Michael B Atkins3
1Division of Hematology Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Background:
Tivozanib is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) with efficacy in advanced renal cell carcinoma (RCC). Long-term exploratory analyses from the TIVO-3 trial in relapsed/refractory (R/R) RCC including patients (26%) with prior immuno-oncology (IO) therapy are reported.
Methods:
Patients with R/R advanced RCC that progressed with 2 or 3 prior systemic therapies (≥1 VEGFR TKI) were randomized to tivozanib 1.5 mg QD or sorafenib 400 mg BID, stratified by IMDC risk and previous therapy. Safety, investigator-assessed long-term progression-free survival (LT-PFS), and serial overall survival (OS) were assessed.
Results:
Mean time on treatment was 11.0 months with tivozanib (n = 175) and 6.3 months with sorafenib (n = 175). Fewer grade ≥3 treatment-related adverse events occurred with tivozanib (46%) than sorafenib (55%). Dose modification rates were lower with tivozanib than sorafenib across age/prior IO subgroups; prior IO therapy did not impact dose reductions or discontinuations in either arm. Landmark LT-PFS rates were higher with tivozanib (3 years: 12.3% vs 2.4%; 4 years: 7.6% vs 0%). After 22.8 months mean follow-up, the OS HR was 0.89 (95% CI, 0.70-1.14); when conditioned on 12-month landmark PFS, tivozanib showed significant OS improvement over sorafenib (HR, 0.45; 95% CI, 0.22-0.91; 2-sided P = .0221).
Conclusions:
Tivozanib demonstrated a consistent safety profile and long-term survival benefit in patients with R/R advanced RCC who were alive and progression free at 12 months. These post hoc exploratory analyses of LT-PFS and conditional OS support a clinically meaningful improvement with tivozanib versus sorafenib in this advanced RCC population.
Insights
Tivozanib offers improved long-term survival for advanced renal cell carcinoma (RCC) patients who did not progress after 12 months. This oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) showed a better safety profile than sorafenib.
Area of Science:
- Oncology
- Pharmacology
Background:
- Tivozanib is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) demonstrating efficacy in advanced renal cell carcinoma (RCC).
- Long-term data from the TIVO-3 trial in relapsed/refractory (R/R) RCC, including patients with prior immuno-oncology (IO) therapy, are presented.
Purpose of the Study:
- To report long-term exploratory analyses of efficacy and safety for tivozanib versus sorafenib in patients with R/R advanced RCC.
- To evaluate the impact of prior immuno-oncology (IO) therapy on treatment outcomes.
Main Methods:
- Patients with R/R advanced RCC progressing after 2-3 prior therapies (including ≥1 VEGFR TKI) were randomized to tivozanib or sorafenib.
- Investigator-assessed long-term progression-free survival (LT-PFS) and overall survival (OS) were assessed, along with safety data.
Main Results:
- Tivozanib showed higher landmark LT-PFS rates at 3 and 4 years compared to sorafenib.
- Fewer grade ≥3 treatment-related adverse events were observed with tivozanib.
- Conditional OS analysis revealed a significant improvement with tivozanib in patients progression-free at 12 months.
Conclusions:
- Tivozanib demonstrated a favorable safety profile and a long-term survival benefit in R/R advanced RCC patients alive and progression-free at 12 months.
- These findings support tivozanib as a clinically meaningful treatment option in this patient population.
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