Acceleron Pharma Inc. said the phase 2 trial of dalantercept plus axitinib to treat advanced renal cell carcinoma, or RCC, a form of kidney cancer, did not achieve its primary endpoint.
Acceleron is disappointed by the results and will discontinue the development of dalantercept based on the lack of efficacy, said President and CEO Habib Dable.
The company had aimed for the study's primary efficacy endpoint to show a statistically significant increase in progression-free survival for dalantercept plus axitinib compared to placebo plus axitinib in advanced RCC patients.
Median progression-free survival for dalantercept plus axitinib was 6.8 months compared to 5.6 months for placebo plus axitinib. Dalantercept plus axitinib did not decrease the rate of disease progression or death.
The key secondary endpoint of the study was progression-free survival for patients who received two or more prior systemic anti-cancer therapies. In this evaluation, the median progression-free survival for dalantercept plus axitinib was 8.1 months versus 7.0 months for placebo plus axitinib. The confirmed objective response rate for dalantercept plus axitinib was 19% versus 25% for placebo plus axitinib.