Iclusig ponatinib: Additional Phase II data

Additional data from 449 patients in the single-arm, international, pivotal Phase II PACE trial showed that once-daily 45 mg oral Iclusig led to treatment-emergent serious arterial thrombotic events, including 21 cardiovascular and 14 cerebrovascular or peripheral vascular events, in 8% of patients. However, 71% of patients who had a cardiovascular event and 43% of patients who had a cerebrovascular or peripheral vascular had pre-existing cardiac disease. Additionally, 30 patients had >=1 pre-existing cardiovascular risk factor, 14 patients had pre-existing ischemic cardiac disease and 19 patients were >=65 years of age. Patients who had a serious arterial thrombotic event had a significantly greater history of ischemic cardiac disease (41% vs. 10%) and were >=65 years of age (56% vs. 33%) than those patients who did not experience an event. Patients with serious arterial thrombotic events also had significantly higher incidences of pre-existing diabetes (44% vs. 14%) and hypertension (82% vs. 51%) compared to those patients who did not experience an event. The trial enrolled 449 patients who are resistant or intolerant to dasatinib or nilotinib or with the T315l variant of BCR-ABL tyrosine kinase. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...