Home » Drug Information » New Medical Therapies™
Soft Tissue Sarcoma
January 24, 2011
ARIAD Pharmaceuticals and Merck released positive results from a phase III trial of ridaforolimus, for the treatment of soft-tissue or bone sarcomas. This randomized, placebo-controlled, double-blind study, SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus), enrolled 711 subjects with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. The subjects received placebo or oral ridaforolimus administered at 40 mg a day for five consecutive days, followed by two days off, until disease progression. The primary endpoint of improved progression-free survival (PFS) compared to placebo was reached. Based on the full analysis of 552 PFS events, determined by an independent review committee, there was a statistically significant (p≡0.0001) 28% reduction by ridaforolimus in the risk of progression compared to placebo. Ridaforolimus treatment resulted in a statistically significant 21% (3.1 week) improvement in median PFS (ridaforolimus, 17.7 weeks versus placebo, 14.6 weeks). Based on the full analysis determined by the investigative sites, there was a statistically significant (p<0.0001) 31% reduction in the risk of progression compared to placebo. Ridaforolimus resulted in a statistically significant 52% (7.7 week) improvement in median PFS (ridaforolimus, 22.4 weeks versus placebo, 14.7 weeks).