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Dasatinib Fails to Improve Outcomes in Core-Binding Factor Acute Myeloid Leukemia: Phase 3 trial Results
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Milan, Italy – A recent phase 3 clinical trial has cast doubt on the effectiveness of dasatinib, a tyrosine kinase inhibitor, as an addition to standard chemotherapy for patients with core-binding factor acute myeloid leukemia (CBF-AML). the study, presented at the 2025 European Hematology association (EHA) Congress, revealed that the addition of dasatinib to induction and consolidation therapy, followed by 12 months of maintenance, did not considerably improve event-free survival (EFS) or overall survival (OS) compared to standard treatment protocols.
dasatinib’s Role in CBF-AML Treatment questioned
The multi-center,randomized trial enrolled 204 patients with CBF-AML between August 2014 and February 2021. participants were assigned to either a standard therapy arm or an arm that included dasatinib in addition to standard chemotherapy. the primary endpoints were EFS and OS. The results indicated that the addition of dasatinib did not provide a statistically notable benefit in either EFS or OS.
Hartmut Dรถhner, MD, from the University Hospital Ulm in Germany, presented the findings, stating that the data “do not support the encouraging data reported in single-arm phase 2 studies,” emphasizing the necessity of rigorous investigation of new agents in controlled, randomized trials.
Did You know? Core-binding factor AML accounts for approximately 10-15% of all AML cases,and is often associated with favorable outcomes with standard chemotherapy American Cancer Society.
Key Trial Results: A Side-by-Side Comparison
The trial data revealed the following outcomes:
| Outcome | Standard Therapy Arm (n = 102) | Dasatinib Arm (n = 100) |
|---|---|---|
| 4-Year event-Free Survival (EFS) | 41% | 44% |
| 4-year Overall Survival (OS) | 76% | 78% |
| Complete Remission (CR) Rate | 64.7% | 55% |
| CR with Incomplete Hematologic Recovery (CRi) | 31.4% | 36% |
| 30-Day Mortality Rate | 2% | 3% |
Adverse Events and Tolerability
While the addition of dasatinib did not improve survival outcomes, it was associated with a higher incidence of certain adverse events (AEs). Hematologic AEs such as leukopenia were more frequent in the dasatinib arm (91% vs. 79%; P = .02). Non-hematologic AEs, including atrial fibrillation (0% vs. 4%; P = .04) and colitis (1% vs. 8%; P = .02), were also more common in the dasatinib arm.
Serious AEs were reported in 64% of patients in the dasatinib arm compared to 36% in the standard arm, with pneumonia/pneumonitis, sepsis, febrile neutropenia, and pyrexia being the most frequent.
Pro Tip: When evaluating cancer treatment options, it’s crucial to consider both the potential benefits and the risks of adverse events.
Implications for Future Research
These findings highlight the importance of conducting randomized controlled trials to validate the efficacy of new treatments, even those that show promise in earlier phase studies. While dasatinib has shown potential in treating CBF-AML, notably in cases with KIT mutations [1, 3], this phase