Acceleron says DART Phase 2 study plus axitinib did not achieve primary endpoint
Acceleron Pharma announced that the DART Phase 2 study of dalantercept plus axitinib did not achieve its primary endpoint in advanced renal cell carcinoma. The primary efficacy endpoint of the study was to demonstrate a statistically significant increase in progression-free survival for treatment of dalantercept plus axitinib versus placebo plus axitinib in advanced RCC patients. The DART study enrolled 131 patients with advanced RCC. The efficacy data are based on the All-Treated Set which is defined as all randomized patients who received any study drug as of the database cutoff. In the ATS, 58 patients were randomized to dalantercept plus axitinib and 61 patients were randomized to placebo plus axitinib. "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."