Hematologic safety data of single-agent ponatinib from a phase I and phase II trial in Philadelphia chromosome-positive (Ph+) CML/ALL patients.

Abstract

e18021 Background: Ponatinib is a tyrosine kinase inhibitor (TKI) indicated for the treatment of Ph+ chronic myeloid leukemia (CML) or acute lymphocytic leukemia (ALL) in the absence of other appropriate TKI therapies or presence of the T315I BCR-ABL mutation. Hematologic toxicity can result in dose reductions, interruptions and discontinuation of drug therapy. In the following analysis, we summarize the hematologic safety profile of single agent ponatinib reported in 468 patients from 2 trials. The primary objective is to evaluate the number and percent of patients with hematologic toxicities based on previously published data. Methods: Data reported from patients treated with ponatinib in trials 10-201 and 07-101 was included in the analysis. Ponatinib was dosed at 45 mg orally once daily. Hematologic adverse effects analyzed included thrombocytopenia, neutropenia, anemia and arterial thrombotic events. Results: See Table below for summary of events. Thrombocytopenia, neutropenia and anemia were more fr...