AV-951

AV-951 is a novel, highly potent and specific inhibitor of VEGF receptors 1, 2 and 3.  Angiogenesis inhibition has demonstrated benefit for patients with a wide range of cancer types, including renal cell carcinoma, metastatic breast cancer, colorectal cancer, and non-small cell lung cancer.  Due to its specificity, AVEO believes AV-951 may be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility.  AVEO’s translational research effort, comprising its Human Response Platform, offers an opportunity to exploit AV-951’s unique characteristics and will provide further insight into potential clinical settings, combinability with other anti-cancer agents, tumor subtypes and responsive patient populations.

Phase I Data
Strong activity was observed in the Phase 1 clinical trial consisting of 40 patients with advanced solid tumors; AV-951 was also found to be well tolerated. Notably, of the nine patients with refractory renal cell carcinoma, all achieved either a partial response or stable disease as defined by the trial protocol, with one patient exhibiting a response lasting more than 30 months. 

Initial Phase II Study
AVEO has initiated a Phase 2 clinical trial of AV-951 in patients with metastatic renal cell carcinoma.  The placebo-controlled, randomized discontinuation trial will assess the safety and efficacy of once-daily, oral AV-951 in approximately 200 patients at 30 sites in Europe and India under a U.S. IND.  The primary endpoints of this trial are objective response rate and percentage of patients who are progression free at 12 weeks following randomization.

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