Dalantercept is a first-in-class protein therapeutic that inhibits angiogenesis, the formation of new blood vessels to feed cancer cells the nutrients and oxygen they need to grow and spread throughout the body. We are studying dalantercept in patients with advanced renal cell carcinoma (RCC), the most common type of kidney cancer. There are several approved angiogenesis inhibitors on the market and some in development that work by blocking the vascular endothelial growth factor (VEGF) pathway. While many of these therapies have shown robust activity in RCC, there is a substantial opportunity for dalantercept with its complementary mechanism of action to enhance their efficacy and help improve outcomes in RCC in combination with such currently approved tyrosine kinase inhibitors (TKIs) as axitinib, cabozantinib, sunitinib and pazopanib.
We are currently enrolling part 2 of the randomized DART Phase 2 study of dalantercept in combination with axitinib (Pfizer) in patients with advanced renal cell carcinoma. The primary endpoint of this trial, progression-free survival, is an event-driven assessment with topline results expected in 2017. Previous studies indicated that adding dalantercept to axitinib treatment led to improved clinical outcomes in patients with RCC. Based on the Phase 2 data, we will consider potential partnership opportunities for dalantercept.