Merck and Ariad Pharmaceuticals, Inc. announced results from the Phase III Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus (SUCCEED) clinical trial, which 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), the primary endpoint of the study with a statistically significant 28% reduction in the risk of progression or death observed in those treated with ridaforolimus compared to placebo).The trial was a randomized, placebo-controlled, double-blind study of oral ridaforolimus administered at 40 mg/day, five days a week. Oral ridaforolimus was granted a Special Protocol Assessment (SPA) by the FDA for the trial.
The most common side effects observed in the study were consistent with the known safety profile of ridaforolimus. The most common adverse events occurring at an incidence in the ridaforolimus group compared to placebo were stomatitis infections, fatigue, thrombocytopenia diarrhea, and cough. There were six deaths due to pulmonary disorders in the ridaforolimus treatment group and no deaths due to pulmonary disorders in the placebo group.
“Patients with metastatic soft-tissue and bone sarcomas have limited treatment options available to them. Data from the SUCCEED trial show that ridaforolimus maintained the benefit of prior conventional chemotherapy,” says Sant P. Chawla, MD, director, Sarcoma Oncology Center. “The study met the primary endpoint of progression-free survival, showing a clinically meaningful and statistically significant improvement in PFS in those patients treated with oral ridaforolimus.”
Based on these results, Merck plans to submit a New Drug Application (NDA) for ridaforolimus to the FDA and a marketing application in the European Union this year.
Release Date: June 6, 2011
Source: Ariad Pharmaceuticals, Inc.
Filed Under: Drug Discovery