Long-term data highlight sustained efficacy of tivozanib in advanced kidney cancer

The FDA approved tivozanib in 2021 for the treatment of adult patients with relapsed or refractory advanced RCC following 2 or more prior systemic therapies based on previously report data from the TIVO-3 trial.

Long-term results showed continued efficacy and safety with tivozanib (Fotivda) in patients with relapsed or refractory advanced renal cell carcinoma (RCC), according to a post-hoc analysis from the phase 3 TIVO-3 trial published in The Oncologist.^1,2

The landmark 3-year progression-free survival (PFS) rates were 12.3% with tivozanib compared with 2.4% with sorafenib. The 4-years rates were 7.6% vs 0%, respectively. At 22.8 months’ follow-up, the hazard ratio for overall survival (OS) for tivozanib was 0.89 (95% CI, 0.70-1.14).

AVEO Oncology, the developer of tivozanib, noted in a news release that, “when conditioned on a clinically meaningful 12-month PFS time point, Fotivda showed significant improvement in OS compared to sorafenib (HR: 0.45; 95% CI, 0.22-0.91; 2-sided P = 0.0221).”¹

The mean duration of treatment was 11.0 months and 6.3 months for tivozanib and sorafenib, respectively. Patients receiving tivozanib experienced fewer treatment-related adverse events (TRAEs) and lower rates of dose modification compared with patients receiving sorafenib. Similarly, the rates of grade ≥3 TRAEs were 46% vs 55% with tivozanib vs sorafenib, respectively. Receipt of prior immunotherapy had no impact on dose reductions or discontinuations in either the tivozanib or sorafenib arms.

“The post-hoc analysis from TIVO-3 provides additional evidence supporting the clinical utility of tivozanib in the third- or fourth-line refractory setting in patients with advanced renal cell carcinoma,” lead author Kathryn E. Beckermann, MD, PhD, assistant professor of Medicine in the Division of Hematology Oncology at Vanderbilt-Ingram Cancer Center, stated in a news release.¹ “The results suggest there is a clinically meaningful population of patients who can experience a long-term survival benefit from tivozanib over sorafenib.”

In the multicenter, open-label, randomized TIVO-3 trial, 350 patients were split evenly between tivozanib and sorafenib and stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy.³ These patients had to progress on 2 or 3 prior systemic regimens, at least 1 of which had to be a VEGFR tyrosine kinase inhibitor other than sorafenib or tivozanib.

Patients either received 1.5 mg of tivozanib mg orally once a day on 4-week cycles or sorafenib at 400 mg orally twice a day continuously. The primary end point was PFS by independent review in the intention-to-treat population.

The FDA approved tivozanib in 2021 for the treatment of adult patients with relapsed or refractory advanced RCC following 2 or more prior systemic therapies based on previously report data from the TIVO-3 trial. The study data the FDA reviewed showed an increased median PFS for tivozanib compared with sorafenib of 5.6 months versus 3.9 months, respectively (HR, 0.73; P = .016).

“For patients with relapsed or refractory advanced renal cell carcinoma, long-term progression-free survival is a vital measure of the value of anticancer therapy,” Michael Bailey, president and CEO of AVEO Oncology, stated in a news release.¹ “The long term PFS analysis combined with the post hoc conditional survival analysis is especially encouraging in this highly refractory population, as it builds upon the previously reported PFS advantage for FOTIVDA over sorafenib, a non-selective VEGFR TKI.”

Resources

1. AVEO Oncology Announces Publication of Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial in The Oncologist. Published online and accessed February 6, 2023. https://finance.yahoo.com/news/aveo-oncology-announces-publication-long-131000516.html

2. Beckermann KE, Asnis-Alibozek AG, Atkins MB, et al.Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial [published online ahead of print January 23, 2024].Oncologist. doi: 10.1093/oncolo/oyad348

3. AVEO Oncology Announces U.S. FDA Approval of FOTIVDA® (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma. Published online March 10, 2021. Accessed March 10, 2021. https://bwnews.pr/3vbdRY4.