On March 22, 2017 AVEO Oncology (NASDAQ:AVEO) reported that the first patient has been dosed in the Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced renal cell carcinoma (RCC) (Press release, AVEO, MAR 22, 2017, View Source [SID1234518233]). The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase 2 cohort at the established combination dose. Schedule your 30 min Free 1stOncology Demo! "There is compelling scientific rationale for combining the antiangiogenic activity of VEGF inhibition with the immunologic activity of PD-1 inhibitors. Yet, to date, the tolerability of these combinations have been a challenge with currently approved VEGF TKIs and PD-1s," said Professor Escudier. "Tivozanib has been demonstrated to be the most selective VEGF inhibitor, delivering a uniquely favorable tolerability profile in past single agent and combination studies, and has the potential for minimal overlapping toxicities with immunotherapies. I look forward to understanding the clinical potential of combining tivozanib and nivolumab in the TiNivo study, and to the prospect of further improving outcomes in this very dynamic treatment area."
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"VEGF-PD-1 combinations have yielded promising tumor response outcomes in renal cell cancer, yet the data presented to date point to challenging or prohibitive toxicity," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib offers a unique opportunity to potentially overcome this barrier, and look forward to initial results from the Phase 1 portion of the TiNivo trial in the first half of 2017."
About Tivozanib
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.