Dasatinib does not cross the finish line in the phase 3 AML study

The addition of dasatinib to chemotherapy did not improve efficacy outcomes for patients with core-binding factor acute myeloid leukaemia (CBF-AML). Moreover, the investigational regimen was associated with a higher incidence of serious adverse events (AEs) in the phase 3 AMLSG trial (NCT02013648).

The open-label phase 3 study randomised 202 adult patients with CBF-AML 1:1 to induction and consolidation chemotherapy or to chemotherapy plus dasatinib, including dasatinib maintenance therapy. The primary endpoint was event-free survival (EFS), and Dr Hartmut Döhner (University Hospital Ulm, Germany) presented the final results of the study [1].

The 4-year EFS rates were 41% in the standard-of-care arm and 44% in the dasatinib arm, not showing a significant difference between the two study arms (HR 0.92; 95% CI 0.63-1.33; log-rank P=0.66). Similarly, the 4-year overall survival rates were 76% and 78% (HR 0.93; 95% CI 0.53-1.63; log-rank P=0.79). “These findings were consistent across KIT mutation status and CBF-AML type subgroups,” mentioned Dr Döhner.

Of the AEs that were of grade 3 or higher, leukopenia appeared to be more common in the standard-of-care arm (91% vs 79%; P=0.02), whereas atrial fibrillation (0% vs 4%; P=0.04), colitis (1% vs 8%; P=0.02), pneumonia (19% vs 29%; P=0.09), and acute kidney injury (0% vs 4%; P=0.04) may be more prevalent in patients on dasatinib. “We observed a higher incidence of serious AEs in patients on dasatinib (64%) than in patients on standard-of-care (36%; P<0.001),” Dr Döhner addressed the difference in safety profiles.

“These data do not support the encouraging phase 2 data that we saw for the dasatinib-containing regimen,” Dr Döhner delivered a sobering conclusion. “It underscores the importance of investigating novel agents in randomised controlled trials.”

1. Dohner H, et al. Phase 3 study of intensive chemotherapy with or without dasatinib in core-binding factor acute myeloid leukemia. S149, EHA2025 Congress, 12–15 June, Milan, Italy.

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Posted on 2 September 20254 September 2025