Sarcomas are a group of aggressive cancers of connective tissue in the body for which there are currently limited treatment options. ARIAD is conducting a Phase 3 clinical trial of deforolimus in patients with metastatic soft-tissue and bone sarcomas.
During 2008, the American Cancer Society estimates that approximately 10,300 new cases of soft tissue sarcomas will be diagnosed in the United States, and over 3,600 Americans will die of the disease. In addition, approximately 2,400 new cases of bone sarcomas will be diagnosed and nearly 1,500 deaths are estimated.*
Deforolimus has been designated both as a fast-track and orphan drug product by the U.S. Food and Drug Administration (FDA) and as an orphan drug by the European Medicines Agency (EMEA) for the treatment of soft-tissue and bone sarcomas. ARIAD is pursuing this indication as the initial registration path for deforolimus.
- For more information on the open Phase 3 SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Deforolimus) trial for patients with metastatic soft tissue or bone sarcomas, please visit www.succeedtrial.com or contact the U.S. toll-free number 1-877-621-2302 or the international number 1-617-621-2302.
- For specific information on sites and enrollment status on clinical trials with deforolimus in various cancers, please visit www.clinicaltrials.gov or please email us at ClinicalTrials@ARIAD.com.
- For patient education, please view our list of organizations with helpful information about sarcoma.
Phase 3 SUCCEED Clinical Trial in Sarcoma
In September 2007, we initiated the SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Deforolimus) trial, a global Phase 3 clinical trial of oral deforolimus in patients with metastatic soft-tissue and bone sarcomas. This pivotal trial, being conducted by ARIAD in collaboration with Merck & Co., Inc., will assess progression-free survival (PFS) as the primary endpoint and overall survival as a secondary endpoint in patients with metastatic sarcomas following a favorable response to chemotherapy.
We have reached agreement on a Special Protocol Assessment (SPA) with the FDA for the SUCCEED trial. The EMEA has provided protocol advice consistent with that of the FDA regarding the trial design as part of its Protocol Assistance program.
Positive Clinical Results from Deforolimus Phase 2 Trial in Sarcoma
In a multi-center Phase 2 trial of 212 patients with advanced sarcomas, at least 90% of whom had progressive disease, deforolimus demonstrated efficacy and was well tolerated. The primary endpoint of the trial – evidenced by clinical-benefit response (CBR) rates – was achieved in the three most prevalent types of sarcoma (i.e., bone sarcoma, leiomyosarcoma and liposarcoma). Treatment with deforolimus more than doubled progression-free survival when compared to 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 deforolimus demonstrated that documented disease stabilization and/or tumor regression with single-agent deforolimus is a strong predictor of improved overall survival. Specifically, patients with a deforolimus 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 (vs. approximately 9 months).
* Source: American Cancer Society, Cancer Facts & Figures 2008.
