US-based biopharmaceutical company Aveo Oncology (Aveo) has started dosing in a Phase lll randomised, controlled, multi-centre, open-label trial (TIVO-3) to compare tivozanib with sorafenib in patients with refractory advanced renal cell carcinoma (RCC).
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) and has been investigated in several tumours types, such as renal cell, colorectal and breast cancers.
The TIVO-3 trial will enrol around 322 patients with recurrent or metastatic RCC who have failed at least two prior regimens, including VEGFR-TKI therapy other than sorafenib.
Eligible subjects could also have received checkpoint inhibitor therapy in earlier lines of treatment.
During the trial, patients will be randomised in a 1:1 ratio to receive either tivozanib or sorafenib, with no crossover between arms.
The primary endpoint of the trial is progression free survival, while secondary endpoints include overall survival, overall response rate, and safety and tolerability.
Data from the trial are expected to come in the first quarter of 2018.
The TIVO-3 trial, along with the previously closed 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 US.
Aveo oncology president and CEO Michael Bailey said: "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.
"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."
Aveo is currently forming multiple partnerships with an aim to develop and commercialise tivozanib in non-oncologic indications throughout the world and oncology indications outside of North America.
Cleveland Clinic Lerner College of Medicine, US, medicine professor Dr Brian Rini said: "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.
"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."