ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced enrollment of fifty percent of the patients planned in its randomized Phase 3 trial of Iclusig ® (ponatinib) in adult patients with newly diagnosed chronic myeloid leukemia (CML). The trial, formally known as EPIC ( Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia), is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients.
An interim analysis of efficacy -- focused on the primary endpoint of major molecular response rate (MMR) at twelve months -- will be performed in the third quarter of 2014 based on the patients enrolled to date. Approximately 264 patients have been enrolled in the EPIC trial, and full patient enrollment of approximately 500 patients in the trial is anticipated by the end of 2013.
“The EPIC trial is a very important study in the ongoing global development of Iclusig and will inform our clinical understanding of Iclusig in patients with newly diagnosed CML,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Depending on the outcome of the interim analysis, we may be able to file for regulatory approval of Iclusig in this front-line setting approximately six months earlier than currently planned.”
Trial Design and Statistical AnalysisThe EPIC trial is a randomized, two-arm, multicenter trial that compares the efficacy of ponatinib with that of imatinib in adult patients with newly diagnosed CML in the chronic phase. The trial is currently being conducted at approximately 150 investigational sites in more than 20 countries. Patients in the trial must be at least 18 years of age and diagnosed with CML within six months prior to enrollment. Approximately 500 patients are randomized 1:1 to the standard dose of ponatinib (45 mg given orally once daily) or imatinib (400 mg given orally once daily). Increasing the imatinib dose to 600 mg or 800 mg per day is permitted.