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Updated: May 22, 2026

Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
Developmental Therapeutics Consortium report on study design effects on trial outcomes in chronic myeloid leukaemia
Francis Giles1, François-Xavier Mahon, Bjorn Gjertsen
1HRB Clinical Research Facility, National University of Ireland Galway and Trinity College Dublin, Dublin, Ireland. frankgiles@aol.com
Background:
Tyrosine kinase inhibitors (TKIs) have dramatically changed the treatment of chronic myeloid leukaemia (CML). Results from ongoing phase 3 trials with nilotinib [Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd)] and dasatinib [Dasatinib Versus Imatinib Study in Treatment-Naive CML-CP Patients (DASISION)] in newly diagnosed patients with CML in chronic phase have demonstrated that these TKIs resulted in significant improvements in responses vs. imatinib.
Design:
The Developmental Therapeutics Consortium (DTC) systematically reviewed the published literature to provide a comparative analysis of the ENESTnd and DASISION trial designs and data reported on each study.
Results:
The recent approval of nilotinib and dasatinib based on these two pivotal studies offers physicians the option to optimise frontline treatment based on a patient's comorbidities, risk factors and tolerability profiles. Although nilotinib and dasatinib provide effective therapeutic options for the frontline treatment of CML, the lack of an evidenced-based, side-by-side comparison makes it difficult to directly compare these agents.
Conclusions:
Despite potential bias from differences in patient populations and study design, indirect cross-trial comparisons to determine the relative effectiveness of these agents will be performed by physicians. This DTC report provides a comprehensive summary of the study designs, protocols and results of the ENESTnd and DASISION trials, which will assist physicians in making informed decisions on the best treatment approach for their patients.
Insights
Nilotinib and dasatinib offer improved responses in chronic myeloid leukaemia (CML) compared to imatinib. This review compares ENESTnd and DASISION trials to aid physicians in selecting optimal frontline CML treatments.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Tyrosine kinase inhibitors (TKIs) have transformed chronic myeloid leukaemia (CML) treatment.
- Phase 3 trials (ENESTnd, DASISION) show nilotinib and dasatinib improve responses over imatinib in newly diagnosed CML patients.
Purpose of the Study:
- To provide a comparative analysis of the ENESTnd and DASISION trial designs and reported data.
- To assist physicians in making informed decisions for frontline CML treatment.
Main Methods:
- Systematic literature review by the Developmental Therapeutics Consortium (DTC).
- Comparative analysis of ENESTnd and DASISION trial designs and outcomes.
Main Results:
- Nilotinib and dasatinib offer effective frontline CML treatment options.
- Physicians can optimize treatment based on patient comorbidities, risk factors, and tolerability.
Conclusions:
- Direct comparison of nilotinib and dasatinib is challenging due to study design and population differences.
- This DTC report summarizes trial data to aid physician decision-making for CML therapy.
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