WASHINGTON (dpa-AFX) - ARIAD Pharmaceuticals Inc. (ARIA) announced preliminary safety and efficacy data from the discontinued Phase 3 EPIC trial of Iclusig (ponatinib) vs. imatinib in patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML).
On October 18, 2013, in consultation with the U.S. FDA, ARIAD terminated the EPIC trial due to the observation of the accumulation of arterial thrombotic events in the ponatinib clinical program. None of the prospectively defined endpoints could be analyzed due to the early termination of the trial, the company said.
Major Molecular Response (MMR) at 12 months was the primary endpoint of the trial. While the primary end-point of the trial could not be assessed, the MMR rate at 12 months was higher for ponatinib patients than for imatinib patients, the company said.
Analysis of key secondary endpoints provided preliminary evidence of efficacy of ponatinib compared to imatinib in newly diagnosed patients with chronic-phase CML at the doses studied and at the time points reached, the company said. There were more adverse events in the ponatinib arm compared with imatinib.
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