Ridaforolimus Phase III SUCCEED clinical trial on metastatic sarcoma meets primary endpoint

Jun 7 2011

Merck (NYSE:MRK), known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), today announced the presentation of detailed results from the Phase III SUCCEED clinical trial. SUCCEED evaluated oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. In this patient population, ridaforolimus improved progression-free survival (PFS) compared to placebo, the primary endpoint of the study. The complete study results were presented by Sant P. Chawla, M.D., director, Sarcoma Oncology Center, Santa Monica, CA, during the 2011 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

“We are pleased with the results of the SUCCEED trial and look forward to Merck filing for marketing approval of ridaforolimus.”

Based on these results, Merck plans to submit a New Drug Application (NDA) for ridaforolimus to the U.S. Food and Drug Administration (FDA) and a marketing application in the European Union this year. "These data bring us one step closer to making ridaforolimus available to patients with metastatic sarcoma who need it and reinforces our ongoing commitment to developing innovative therapies to treat cancer," said Eric Rubin, M.D., vice president of clinical oncology research at Merck.