Biotech company Accerelon announced it will discontinue development of dalantercept to treat renal cell carcinoma (RCC).
The decision was based on preliminary results from their DART Phase 2 study of the drug in advanced RCC and was announced today by the company.
RCC, a kidney cancer, begins in the lining of the proximal convoluted tubules, and although it is a rare cancer, RCC is the most common type of kidney cancer in adults. It accounts for an estimated 90–95% of cases, and at present, treatment is usually a surgical removal of the affected area.
In the Phase 2 study, 119 RCC patients who had worsened after treatment with a VEGF receptor tyrosine kinase inhibitor were randomized to receive dalantercept plus axitinib or placebo plus axitinib. At the the study’s end, no statistically significant increase in progression-free survival was observed in patients given dalantercept plus axtinib.
Dalantercept, an investigational protein therapeutic, was designed specifically to improve patient outcomes in RCC, and is a first-in-class protein therapeutic that impedes the formation of new blood vessels to feed cancer cells the nutrients and oxygen they need to grow and spread throughout the body, known as angiogenesis.
“We designed a robust Phase 2 study to evaluate the efficacy of dalantercept in combination with anti-VEGF therapy in advanced renal cell carcinoma patients whose disease has progressed on prior anti-VEGF therapy. We are disappointed by the results given the need for new agents that improve outcomes for patients with advanced RCC. We would like to thank the patients, caregivers, investigators, and our team who made the DART study possible,” said Habib Dable, President and Chief Executive Officer of Acceleron.
“Based on the lack of efficacy, we are discontinuing the development of dalantercept. We remain focused on the development of luspatercept across multiple Phase 3 and Phase 2 studies and ACE-083 across two neuromuscular diseases, and will continue to pursue additional candidates in areas of high unmet medical need.”
Additional information about the Phase 2 can be seen at clinicaltrials.gov
, identifier NCT01727336.