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PrECOG 0905 trial: Gilteritinib vs midostaurin + intensive chemotherapy in patients with newly diagnosed FLT3-mutated AML
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Gilteritinib, a highly potent selective FLT3 inhibitor, is approved as monotherapy for the treatment of relapsed/refractory FLT3-mutated AML. At the 66th ASH Annual Meeting and Exposition, Luger presented the findings of the phase II PrECOG 0905 trial (NCT03836209), evaluating the efficacy of gilteritinib vs midostaurin in combination with intensive chemotherapy in patients with newly diagnosed FLT3-mutated AML.1 Eligible patients (N = 177) were stratified by mutation type and randomized 1:1 to receive cytarabine + daunorubicin + gilteritinib (n = 90) or cytarabine + daunorubicin + midostaurin (n = 87) during induction and consolidation.1 The primary endpoint was the FTL3-mutation MRD-negative CRc rate post-induction. Secondary endpoints included CRc, MRD negativity (10−3) by flow cytometry, and survival.1 |
| Key learnings |
| The CRc (85.6% vs 72.4%; p = 0.042) and MRD-negativity (10−3) rates (64.4% vs 59.8%) were higher in the gilteritinib arm compared to the midostaurin arm. |
| The gilteritinib arm had a lower post-induction FLT3-mutation CRc rate than the midostaurin arm (40.0% vs 47.1%; p = 0.366). |
| TRAEs were reported in 82.0% of patients receiving gilteritinib vs 75.0% of patients receiving midostaurin, with SAEs reported in 11% and 10% of patients, respectively. |
| Among patients who achieved CRc and were FLT3-mutated MRD-positive at the end of induction (n = 27), 83.3% of patients receiving gilteritinib and 44.4% of patients receiving midostaurin were MRD-negative post-consolidation C1 (p = 0.072). |
| Findings from the PrECOG 0905 trial suggest that post-induction gilteritinib vs midostaurin plus intensive chemotherapy resulted in improved CRc rate but not mutational MRD-negative rate in patients with newly diagnosed FLT3-mutated AML. |
Abbreviations: AML, acute myeloid leukemia; ASH, American Society of Hematology; C1, first cycle; CRc, composite complete remission; MRD, measurable residual disease; SAE, serious adverse event; TRAE, treatment-related adverse event.
- Luger S. Oral abstract #221. Gilteritinib results in higher remission and transplant rates than midostaurin but does not increase the post-induction mutational MRD negative rate: Results of the phase 2 randomized Precog 0905 study in newly diagnosed FLT3 mutated AML. 66th American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 7, 2024; San Diego, US.
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