Ariad Pharma Discontinues Phase III Trial of Ponatinib (Iclusig) in Leukemia Patients
FDA concerned about thrombotic events (October 18)
Ariad Pharmaceuticals, Inc. has announced that it is discontinuing the phase III EPIC (Evaluation of Ponatinib Versus Imatinib in Chronic Myeloid Leukemia) trial of ponatinib (Iclusig) in patients with newly diagnosed chronic myeloid leukemia (CML).
Ariad and the FDA mutually agreed that the trial should be terminated because arterial thrombotic events were observed in patients treated with the drug.
The EPIC trial was a randomized, two-arm, multicenter study that sought to compare the efficacy of ponatinib with that of imatinib in adult patients with newly diagnosed CML in the chronic phase. The trial was being conducted in more than 20 countries. Patients had to be at least 18 years of age and diagnosed with CML within 6 months prior to enrollment.
Approximately 500 patients were to be randomly assigned to the standard dose of ponatinib (45 mg once daily) or imatinib (400 mg once daily). Increasing the imatinib dose to 600 mg or 800 mg per day was permitted. The trial’s primary endpoint was a major molecular response after 12 months of treatment.
Iclusig (ponatinib) is commercially available in the U.S. for patients with resistant or intolerant CML and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Source: Ariad Pharmaceuticals; October 18, 2013.