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news.AVEO Oncology has dosed the first patient in its pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC).
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Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
The Phase 3 trial is expected to enroll approximately 322 patients with recurrent or metastatic RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms.
The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. Top line readout of the study is currently projected for the first quarter of 2018.
The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a first and third line indication for tivozanib in the U.S.
Marketing authorization applications seeking approval of tivozanib as a treatment for first line renal cell cancer are currently pending in Europe and Russia based on applications submitted by AVEO’s partners EUSA Pharma and Pharmstandard in those respective territories.
"While significant advances have been made in the treatment of renal cancer, there remains a need for effective yet more tolerable treatments, both for single agent and combination use," said Brian Rini, M.D., Professor of Medicine at the Cleveland Clinic Lerner College of Medicine.
"In past studies, tivozanib has demonstrated a unique tolerability profile among VEGF targeted therapies, owing to its high selectivity for the VEGF pathway, that have resulted in fewer dose interruptions or reductions. I am pleased to see tivozanib return to the clinic, with the goal of better understanding its single agent potential through TIVO-3, and I look forward to realizing its potential for combination use with checkpoint inhibitors in future studies."
"Launch of the pivotal TIVO-3 trial marks a vital step forward for our North American development and registration strategy for tivozanib, and is a defining moment in the turnaround story unfolding at AVEO," said Michael Bailey, president and chief executive officer of AVEO.
"In less than 18 months, we have meaningfully progressed our defined clinical development and regulatory paths forward for tivozanib in the US and Europe, executed multiple partnerships to advance and de-risk our pipeline while retaining substantial North American rights to our three oncology therapeutic assets, and strengthening our balance sheet. We look forward to diligently executing on this study, and to a number of potential value creating milestones, including those that could arise from tivozanib approval decisions, in the quarters ahead."
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). 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.
Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.