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Ponatinib Shows Promise in CML Even After Early Trial Termination -

January 13, 2015 | Chronic Myeloid Leukemia, ASH 2014, Hematologic Malignancies, Leukemia & Lymphoma By Dave Levitan Despite the early termination of a phase III trial due to safety concerns, an analysis suggests that ponatinib offers improved efficacy over imatinib in patients with newly diagnosed chronic-phase chronic myeloid leukemia (CP-CML). That improvement comes at the expense of higher rates of adverse events, according to the EPIC trial.

That improvement comes at the expense of higher rates of adverse events, according to the EPIC trial.

EPIC was a multinational, multicenter, randomized, open-label trial. It included 307 patients, with a median follow-up of only 5.1 months. The trial was terminated in October 2013 after a signal for increased risk of arterial thrombotic events was observed in the ponatinib treatment arm. Because of that early termination, none of the predefined endpoints could be thoroughly analyzed, but researchers presented other relevant data based on a cutoff of April 1, 2014. The analysis, led by Jeffrey H. Lipton, MD, PhD, of Princess Margaret Cancer Centre at the University of Toronto in Canada, was presented at the American Society of Hematology Annual Meeting in San Francisco in December 2014.

- See more at: http://www.cancernetwork.com/chronic-myeloid-leukemia/ponatinib-shows-pr...