AVEO Oncology Announces Clinical Collaboration with AstraZeneca

AVEO Oncology has entered into a clinical collaboration with AstraZeneca to evaluate the safety and efficacy of AstraZeneca's Imfinzi (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with Fotivda (tivozanib), AVEO’s oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) in first-line hepatocellular carcinoma (HCC), or liver cancer, in a Phase 1/2 study.

AVEO will serve as the study sponsor, with study costs shared equally by both parties and clinical drug supplied by each respective company. The Phase 1 portion of the study is expected to commence in 2019.

"We are thrilled to collaborate with AstraZeneca to explore another tivozanib-immunotherapy combination and look forward to understanding the potential of combining tivozanib with durvalumab in liver cancer," said Michael Bailey, president and chief executive officer of AVEO. "TKI-immunotherapy combinations have demonstrated important clinical potential across multiple tumor types, though toxicities associated with these combinations have limited their potential use. Our goal is to establish tivozanib as the TKI of choice for use with immunotherapies by demonstrating efficacy with reduced toxicity."

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 (RCC) 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. 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. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

Durvalumab (Imfinzi) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with immuno-oncology (IO) agents, small molecules, and chemotherapies across a range of tumors and stages of disease.

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