Aveo Pharmaceuticals presents new data from Phase 3 TIVO-3 trial of tivozanib
AVEO Oncology announced the presentation of updated data from the Phase 3 TIVO-3 trial. The data were presented on Saturday, November 16, 2019, at the 18th International Kidney Cancer Symposium in Miami, in an oral presentation titled "TIVO-3: A Phase 3 Study to Compare Tivozanib to Sorafenib in Subjects with Refractory Advanced Renal Cell Carcinoma Overall Survival 2-Year Update" by Sumanta Kumar Pal, M.D., Associate Clinical Professor, Department of Medical Oncology and Therapeutics Research, and Co-director, Kidney Cancer Program, at City of Hope Comprehensive Cancer Center. TIVO-3 is the company's Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the company's vascular endothelial growth factor receptor tyrosine kinase inhibitor, to sorafenib in 350 subjects with highly refractory metastatic RCC. As previously presented, results for the intent to treat population showed that tivozanib significantly improved progression free survival (PFS), the study's primary endpoint, and overall response rate compared to sorafenib, with responses to tivozanib more durable than sorafenib. Newly presented data include the recently announced interim overall survival hazard ratio of 0.99 within the ITT population, as well as results from two prespecified subgroup analyses of patients previously treated with a checkpoint inhibitor and a VEGF-TKI, or two VEGFR-TKIs. Superior PFS and ORR, as well as OS HRs below 1, favoring tivozanib, were observed in the prespecified subgroups. Tivozanib was shown to have lower overall rates of adverse events and fewer dose interruptions and reductions versus sorafenib, indicating better patient tolerability.