About The Trial
Trial Name: A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
ClinicalTrials.gov ID: NCT02627963
Sponsor: AVEO Pharmaceuticals Inc
Completion Date: June 2021
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Tivozanib Shows Benefits in Long-Term Survival for Relapsed/Refractory Renal Cell Carcinoma
Investigators noted that the conditional overall survival also had clinically meaningful improvements compared with sorafenib for advanced renal cell carcinoma.
In a post-hoc analysis, tivozanib (Fotivda; AVEO Oncology) showed a consistent safety profile and long-term survival for patients with relapsed/refractory (R/R) advanced renal cell carcinoma (RCC) who were alive and progression-free at 12 months, according to results of a study published in The Oncologist. Further, investigators noted that the conditional overall survival (OS) also had clinically meaningful improvements compared with sorafenib (Nexavar; Bayer Healthcare) in this patient population.1,2
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“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,” Kathryn E Beckermann, MD, PhD, assistant professor of Medicine in the Division of Hematology Oncology at Vanderbilt-Ingram Cancer Center, said in a press release. “The results suggest there is a clinically meaningful population of patients who can experience a long-term survival benefit from tivozanib over sorafenib.”1
TIVO-3 (NCT02627963) is a phase 3, open-label, randomized, controlled trial, which compared tivozanib to sorafenib for patients with R/R advanced RCC. Treatment was randomized 1:1, and patients were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk factor and prior therapy. Investigators evaluated for progression-free survival (PFS), OS< objective response rate, duration of response, safety, tolerability, and pharmacokinetics. According to the study authors, this is the first phase 3 trial that prospectively evaluated the long-term efficacy data for this patient population.2,3
Investigators included 350 individuals with 175 in each arm. The safety analysis included 173 individuals in the tivozanib arm and 170 in the sorafenib arm, according to the study authors. In both arms, the median time from diagnosis to randomization was approximately 50 months.2
The long-term PFS of tivozanib was higher at 3 and 4 years at 12.3% and 7.6%, respectively, compared with sorafenib at 2.4% and 0%, respectively. Further, at 22.8 months of follow up, the OS hazard ratio was 0.89 when investigators conditioned the 12-month landmark PFS, demonstrating an improvement in OS for tivozanib compared with sorafenib. The study authors stated that after 36 months patients receiving tivozanib were more than 5 times more likely to experience long-term PFS compared sorafenib.2
The results showed that patients who were treated with tivozanib stayed on treatment longer at 11 months compared with patients treated with sorafenib at 6.3 months. The duration of treatment was not dependent on age or prior immuno-oncology therapy. Discontinuation and reduction were lower with tivozanib at 20% and 33%, respectively, compared with sorafenib at 37% and 63%, respectively, for those aged 75 years and older.2
Grade 3 or higher treatment-related adverse events attributed to VEGFR TKI were reported in 46% and 55% in tivozanib and sorafenib, respectively, with the most common reactions being hypertension, diarrhea, fatigue, asthenia, rash, and palmar-plantar erythrodysesthesia, according to the study authors.2
References
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. News release. Aveo Oncology. February 6, 2024. Accessed May 9, 2024. https://www.aveooncology.com/aveo-oncology-announces-publication-of-long-term-survivalin-patients-with-relapsed-refractory-advanced-renal-cellcarcinoma-treated-with-tivozanib-analysis-of-the-phase-iiitivo-3-trial-in-the-oncologi/
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. Oncologist. 2024;29(3):254-262. doi:10.1093/oncolo/oyad348
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC). ClinicalTrials.gov Identifier: NCT02627963. June 21, 2021. Accessed May 9, 2024. https://clinicaltrials.gov/study/NCT02627963
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