EPIC- tial open for enrollment: ponatinib vs imatinib in newly diagnosed CML

The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of major molecular response (MMR) rate at 12 months. ARIAD expects to complete patient enrollment in the trial by the end of 2013.

The 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 will be conducted at up to 175 investigational sites in North America, Europe and Asia-Pacific. 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 will be randomized 1:1 to standard doses of ponatinib (45 mg given orally once daily) or imatinib (400 mg given orally once daily). Escalation of the imatinib dose to 600 mg or 800 mg per day is permitted.....more


Ariad EPIC trial