Analysis of the cardiovascular risk profile of Ph+ leukemia patients treated with ponatinib.

7048 Background: Coronary artery disease (CAD), peripheral arterial occlusive disease and cerebrovascular disease have been observed in pts treated with BCR-ABL tyrosine kinase inhibitors (TKIs). While uncommon, these events can be serious complications of BCR-ABL TKI therapy. Methods: The cardiovascular (CV) profile of ponatinib (45 mg/day) was evaluated in 449 pts with chronic myeloid leukemia (CML) or Ph+ acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior TKIs in the phase 2 PACE trial. At analysis (23 July 2012), median follow-up was 12 (0.1-21) mos. Myocardial ischemic events including myocardial infarction (MI), CAD, and angina were analyzed. Results: Myocardial ischemic serious adverse events (SAEs) (14 MI, 5 CAD, 2 angina) were reported in 21/449 pts (5%). 10 of these 21 pts had active cardiac disease at entry characterized by prior MI (4 pts), coronary revascularization (4 pts), or documented CAD; 5 had MI reported on study. 5/21 pts had other cardiac disease at entry (eg, va...