As assessed by independent radiological review, patients with advanced renal cell carcinoma (RCC) treated with AV-951 experienced a 91.7% disease control rate at 16 weeks. The data also demonstrated that AV-951 was well tolerated.
According to the company, objective response rate at 16 weeks was 26.4% (29.6% in clear cell RCC) by investigator assessment and 20.1% (20.6% in clear cell RCC) by independent radiology assessment using standard RECIST criteria.
The Phase II placebo-controlled, randomized discontinuation trial assessed the efficacy and safety of once-daily, oral AV-951 in 272 patients with locally advanced or metastatic RCC and no prior VEGF-targeted therapy. The primary endpoints of this trial are objective response rate at 16 weeks of treatment, percentage of patients who are progression free at 12 weeks following randomization (28 weeks after study entry), and safety.
Tuan Ha-Ngoc, president and CEO of Aveo, said: “These interim Phase II results clearly underscore the value of this novel agent, and we look forward to presenting the complete results from this trial, including PFS data, later in 2009.”