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MORPHO post hoc analysis: Association between MRD and RFS in patients with FLT3-ITD-mutated AML
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Gilteritinib, a second-generation FLT3 inhibitor, demonstrated efficacy and tolerability as monotherapy in the phase III MORPHO trial (NCT02997202) in patients with FLT3-ITD-mutated AML (N = 356). The AML Hub previously reported on the key results and the impact of trial results on clinical practice. A post hoc analysis from this trial was published by Cortes, et al.1 in Blood, evaluating the association between MRD levels and the probability of RFS in patients with FLT3-ITD-mutated AML (n = 341).1 |
| Key learnings |
| More patients relapsed with pre-HCT MRD and post-HCT MRD vs U-MRD, in the placebo arm (39.2% and 51.3% vs 13.4%) and gilteritinib arm (17.7% and 21.9% vs 7.1%). |
| Increasing levels of MRD were correlated with a lower probability of RFS after HCT. The probabilities of survival at MRD0, MRD6, MRD5, and MRD4 were 82.92%, 73.68%, 56.25%, and 40.54%, respectively. |
| Patients with FLT3-ITD and D-MRD pre- or post-HCT had worse RFS rates than patients with U-MRD. 14.8% of participants had multiple FLT3-ITD clones detected as MRD and had worse survival irrespective of treatment arm. |
| These findings show that MRD levels correlate strongly with the probability of RFS. The FLT3-ITD MRD assay may identify which patients with AML could benefit from gilteritinib maintenance. |
Abbreviations: AML, acute myeloid leukemia; D-MRD, detectable measurable residual disease; HCT, hematopoietic stem cell transplantation; MRD0, no detectable MRD pre- or post-HCT; MRD6, mutant reads/total reads >10-6 but <10-5; MRD5, mutant reads/total reads >10-5 but <10-4; MRD4, mutant reads/total reads >10-4; RFS, relapse-free survival; U-MRD, undetectable MRD.
- Levis MJ, Hamadani M, Logan BR, et al. Measurable residual disease and posttransplantation gilteritinib maintenance for patients with FLT3-ITD-mutated AML. 2025. Online ahead of print. DOI: 10.1182/blood.2024025154
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