Reason for optimism---------------------------------------------In a multi-center Phase 2 trial of 212 patients with advanced sarcomas, at least 90 percent of whom had progressive disease, ridaforolimus demonstrated efficacy and was well tolerated. The trial achieved its primary endpoint—evidenced by clinical-benefit response (CBR) rates—in the three most prevalent types of sarcoma (bone sarcoma, leiomyosarcoma and liposarcoma). Treatment with ridaforolimus more than doubled progression-free survival when compared with historical control data published by the European Organization for Research and Treatment of Cancer (EORTC).
At the 2007 annual meeting of the American Society of Clinical Oncology (ASCO), we announced that further analysis of the Phase 2 trial of ridaforolimus demonstrated that documented disease stabilization and/or tumor regression with single-agent ridaforolimus is a strong predictor of improved overall survival. Specifically, patients with a ridaforolimus CBR—tumor regression or disease stabilization for at least 16 weeks—had a median overall survival of approximately 17 months, nearly double that of the overall trial population (approximately 9 months).