Dasatinib in imatinib resistant or intolerant chronic phase Chronic Myeloid Leukaemia patients: 7-year follow-up of study CA180-034

Neil P. Shah,1* Philippe Rousselot,2 Charles Schiffer,3 Delphine Rea,4 Jorge E. Cortes,5 Jorge Milone,6 Hesham Mohamed,7 Diane Healey,7 Hagop Kantarjian,5 Andreas Hochhaus,8 and Giuseppe Saglio,9

Dasatinib was approved at 100 mg once daily for imatinib-resistant or -intolerant patients with chronicmyeloid leukemia (CML) in chronic phase, based on results of the phase 3 CA180-034 (NCT00123474) study. Here we present the final 7-year analysis of this pivotal study, the longest follow-up to date of any second-generation BCR–ABL1 tyrosine kinase inhibitor (TKI).

Patients (n 5670) with imatinib resistant or intolerant CML in chronic phase received dasatinib. Nineteen percent of patients continued on study treatment, with a greater proportion in the 100 mg once daily arm remaining on therapy. Seven-year rates for major molecular response (MMR), progression-free survival (PFS), and overall survival (OS) were similar across doses; MMR,PFS, and OS results were 46, 42, and 65% at 100 mg once daily, respectively.

Improved PFS and OS rates were reported in patients who achieved BCR–ABL1 <10% at 3 and 6 months. No new safety signals were identified. The incidence of drug-related pleural effusion was 28% at 100 mg once daily and 35% at the other three dose groups. Incidence of drug-related pulmonary hyper tension and pulmonary arterial hypertension remained low (<3% across all doses). Arterial ischaemic events occurred in <4% of patients across all doses. These data support the long-term efficacy and well-established safety profile of dasatinib for patients with imatinib resistant or intolerant CML in chronic phase.

Am. J. Hematol. 00:000–000, 2016.VC 2016 The Authors. American Journal of Hematology Published by Wiley Periodicals, Inc.

http://onlinelibrary.wiley.com/doi/10.1002/ajh.24423/epdf