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MORPHO post hoc analysis: Impact of conditioning regimen intensity, MRD, and NPM1 mutations in FLT3-ITD AML
Myeloablative conditioning (MAC) has been proposed as potentially more effective than reduced-intensity conditioning (RIC) in patients with acute myeloid leukemia (AML) undergoing hematopoietic stem cell transplantation (HSCT); however, any benefit of MAC in patients with FLT3-ITD AML remains unclear. A post hoc analysis of data from the MORPHO trial (NCT02997202) of gilteritinib vs placebo, assessing the impact of MAC vs RIC regimens, measurable residual disease status, and NPM1 mutations on outcomes in FLT3-ITD AML, was published by Levis et al. in Blood Advances. This analysis included 341 patients with FLT3-ITD AML who achieved complete remission after ≤2 cycles of intensive chemotherapy and received allogeneic HSCT. Outcomes assessed included overall survival, relapse-free survival, complete remission, and risk of relapse.
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Key learnings |
Although the proportion of patients with FLT3-ITD was reduced post-HSCT, MRD levels remained comparable between MAC and RIC groups, both pre- and post-HSCT, including those receiving melphalan-containing RIC regimens. |
In patients with MRD-negativity pre-HSCT, CIR was similar between MAC and RIC; however, in patients with MRD-positivity pre-HSCT who received placebo, MAC was associated with a numerically lower CIR vs RIC (HR, 0.673; 95% CI, 0.341–1.329). |
Gilteritinib maintenance improved RFS in patients with co-mutated NPM1 and MRD-positivity pre- and post-HSCT (HR, 0.165; 95% CI, 0.048–0.564), but not in patients with wild-type NPM1. |
RFS was also longer with MAC vs RIC in patients with wild-type NPM1, whereas those with NPM1 co-mutations showed no difference (HR, 0.561; 95% CI, 0.349–0.904 vs HR, 0.893; 95% CI, 0.441–1.806). |
The findings suggest that in patients with FLT3-ITD AML undergoing HSCT in first remission, molecular features, including NPM1 mutation status, should be considered when selecting the conditioning regimen, in addition to age and performance status. |
AML, acute myeloid leukemia; CI, confidence interval; CIR, cumulative incidence of relapse; FLT3-ITD, FMS-like tyrosine kinase 3 internal tandem duplication; HR, hazard ratio; HSCT, hematopoietic stem cell transplantation; MAC, myeloablative conditioning; MRD, measurable residual disease; RFS, relapse-free survival; RIC, reduced-intensity conditioning.
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