Based on the analysis of 552 PFS events in 711 patients, the study achieved its primary endpoint with a statistically significant 28% reduction in the risk of progression in patients receiving ridaforolimus, compared to placebo.
In addition, patients receiving ridaforolimus had a statistically significant 21% improvement in median PFS.
The placebo-controlled, randomised (1:1), double-blind Phase III study evaluated oral ridaforolimus, administered at 40mg/day, in patients with metastatic soft-tissue or bone sarcomas who demonstrated a favorable response to prior conventional chemotherapy.
Merck, under an exclusive license and collaboration agreement with Ariad, is currently developing ridaforolimus in multiple cancer indications.
Merck is planning to file for marketing approval of oral ridaforolimus in 2011, depending on the final analysis of all available data from the trail.