On February 11, 2021 AVEO Oncology (Nasdaq: AVEO) reported the presentation of two analyses of the Company’s pivotal TIVO-3 study, its Phase 3 trial comparing tivozanib, AVEO’s next-generation vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) drug candidate, to sorafenib in third- and fourth-line renal cell carcinoma (RCC) (Press release, AVEO, FEB 11, 2021, View Source [SID1234574949]). The data are being presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Genitourinary (GU) Cancers Symposium being held virtually.
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"Data reported today continue to support tivozanib’s differentiation among TKIs and its potential to serve as a meaningful option for RCC patients who have relapsed or become refractory to multiple lines of therapy," said Brian Rini, MD, Chief of Clinical Trials at Vanderbilt Ingram Cancer Center. "Of note, sequencing data suggest differential activity between tivozanib and axitinib, despite both being potent and selective VEGF TKIs. With no existing evidence-based standard of care for this historically difficult-to-treat population, tivozanib could potentially play a key role in the evolving relapsed or refractory RCC treatment landscape."
"These findings enhance our understanding of tivozanib in a clinically relevant patient population and add to the body of data from TIVO-3, which, as the first positive superiority study in patients who have relapsed or become refractory to two or more systemic therapies, could potentially serve as an important guide for treatment decisions in this setting," said Michael Bailey, president and chief executive officer of AVEO. "As we await the U.S. Food and Drug Administration’s decision on our New Drug Application submission for tivozanib as a treatment for relapsed or refractory RCC, we remain focused on commercial preparations to support a robust potential U.S. launch. We are committed to our mission of improving both outcomes and patient experience, and to ensuring that tivozanib becomes available to as many appropriate patients as possible."
ASCO GU Data
Q-TWiST Analysis. A poster titled, "Q-TWiST analysis of tivozanib versus sorafenib in patients with advanced renal cell carcinoma (RCC) in the TIVO-3 study" (abstract 298) highlighted findings from a quality-adjusted time without symptoms or toxicity analysis (Q-TWiST) used to assess health-related quality of life. Findings showed that tivozanib significantly increased Q-TWiST relative to sorafenib in patients treated in the TIVO-3 study (15.04 months vs. 12.78 months; p=0.0493), and tivozanib nearly doubled Q-TWiST compared to sorafenib (10.30 months vs. 5.35 months.) These data suggest that tivozanib may convey tolerability advantages as measured by a patient-centered health-related patient quality of life. Q-TWiST analyses have previously been used to assess other TKIs for the treatment of RCC.
Prior Axitinib Therapy. A presentation titled, "Tivozanib in Patients with Advanced Renal Cell Carcinoma (aRCC) who have Progressed After Prior Treatment with Axitinib: Results from TIVO-3" (abstract 278) highlighted outcomes of TIVO-3 patients who received prior axitinib therapy, now commonly part of front-line advanced RCC treatment. Of this group, patients treated with tivozanib (n=83) demonstrated a median progression free survival (PFS) of 5.5 months compared to 3.7 months for those treated with sorafenib (n=89) (Hazard Ratio of 0.68), with an overall response rate of 13% and 8%, respectively. In addition, prior axitinib therapy did not appear to influence tivozanib tolerability, with adverse events, including dose reductions, interruptions, and discontinuations, similar in patients treated with and without prior axitinib therapy. These results suggest that tivozanib, a selective VEGF TKI, is active following prior axitinib therapy and can potentially provide superior PFS benefit compared to sorafenib, a multi-targeted VEGF TKI.
A copy of each presentation will be available in the Scientific Publications & Presentations section of AVEO’s website.
About Tivozanib (FOTIVDA)
Tivozanib is an oral, once-daily, next-generation VEGF TKI discovered by Kyowa Kirin Co. and approved as FOTIVDA for the treatment of adult patients with advanced RCC in the European Union and other countries in the territory of the Company’s partner, EUSA Pharma (UK) Limited (EUSA territory). 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 is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for adult patients with relapsed or refractory advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin Co. in non-oncology indications.