On March 21, 2018 AVEO Oncology (NASDAQ: AVEO) reported the publication of long-term follow-up results from Study 902, where patients were treated with tivozanib (FOTIVDA) as second-line treatment in advanced renal cell carcinoma (aRCC), in the European Journal of Cancer (Press release, AVEO, MAR 21, 2018, View Source;p=RssLanding&cat=news&id=2339191 [SID1234525460]). The publication, titled "Efficacy of Tivozanib Treatment after Sorafenib in Patients with Advanced Renal Cell Carcinoma: Crossover of a Phase 3 Study," was published online first and is available here. Tivozanib is an oral, once-daily, potent and highly selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).
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In Study 902, a total of 161 patients with aRCC received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Phase 3 TIVO-1 study. As previously reported, median progression-free survival and median overall survival were 11.0 months and 21.6 months, respectively. Overall response rate was 18% and stable disease was 52% for an overall disease control rate of 70%. Tivozanib was generally well tolerated, with adverse events consistent with those observed in previous tivozanib trials. The activity shown in TKI refractory patients compares favorably with data published for other TKI agents in a similar population.
"Publication of Study 902 underscores the activity of tivozanib in the refractory setting, with evidence of encouraging clinical responses, disease control and overall survival outcomes in patients previously treated with a VEGFR TKI," said Michael Needle, M.D., chief medical officer of AVEO. "We believe these efficacy and safety findings in refractory patients support the rationale for our ongoing Phase 3 TIVO-3 study. We anticipate that the results of the TIVO-3 study, together with the results of the previously completed TIVO-1 trial of tivozanib in the first-line treatment of aRCC, will serve as a key component for a potential regulatory approval of tivozanib in the U.S. as a first- and third-line treatment for aRCC. When completed, TIVO-3 will be among the only large randomized datasets in third-line disease, a sizable and growing treatment segment thanks to advances in earlier lines of treatment, and in patients progressing on prior immunotherapy. Based on the current rate of progression-free survival events, we expect top-line results from this study to read out in the second quarter of this year."
About Tivozanib (FOTIVDA)
Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (aRCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy. As part of a North American registration plan, tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.