Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study
Open Access
- 1 August 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Leukemia
- Vol. 34 (8), 2125-2137
- https://doi.org/10.1038/s41375-020-0915-9
Abstract
Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs). In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs (n = 156 Ph+ CP CML,n = 4 Ph+ AP CML,n = 3 Ph-negative/BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). As of >= 1 year after last enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. No patient progressed to AP/BP on treatment. Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.Funding Information
- Pfizer
This publication has 42 references indexed in Scilit:
- Tyrosine Kinase Inhibitors Available for Chronic Myeloid Leukemia: Efficacy and SafetyFrontiers in Oncology, 2019
- Chronic myeloid leukemia: 2018 update on diagnosis, therapy and monitoringAmerican Journal of Hematology, 2018
- Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE TrialJournal of Clinical Oncology, 2018
- Causes of resistance and treatment choices of second- and third-line treatment in chronic myelogenous leukemia patientsAnnals of Hematology, 2015
- Use of Second- and Third-Generation Tyrosine Kinase Inhibitors in the Treatment of Chronic Myeloid Leukemia: An Evolving Treatment ParadigmClinical Lymphoma Myeloma and Leukemia, 2015
- Dasatinib versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid LeukemiaThe New England Journal of Medicine, 2010
- Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid LeukemiaThe New England Journal of Medicine, 2010
- Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinibHaematologica, 2010
- Imatinib in patients with newly diagnosed chronic-phase chronic myeloid leukemiaSeminars in Hematology, 2003
- Imatinib Compared with Interferon and Low-Dose Cytarabine for Newly Diagnosed Chronic-Phase Chronic Myeloid LeukemiaThe New England Journal of Medicine, 2003