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Phase 3 trial of gilteritinib plus azacitidine vs azacitidine for newly diagnosed FLT3mut+ AML ineligible for intensive chemotherapy.
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- Author(s): Wang ES;Wang ES; Montesinos P; Montesinos P; Minden MD; Minden MD; Lee JH; Lee JH; Heuser M; Heuser M; Naoe T; Naoe T; Chou WC; Chou WC; Laribi K; Laribi K; Esteve J; Esteve J; Altman JK; Altman JK; Havelange V; Havelange V; Watson AM; Watson AM; Gambacorti-Passerini C; Gambacorti-Passerini C; Gambacorti-Passerini C; Patkowska E; Patkowska E; Liu S; Liu S; Wu R; Wu R; Philipose N; Philipose N; Hill JE; Hill JE; Gill SC; Gill SC; Rich ES; Rich ES; Tiu RV; Tiu RV
- Source:
Blood [Blood] 2022 Oct 27; Vol. 140 (17), pp. 1845-1857.- Publication Type:
Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase III; Journal Article- Language:
English - Source:
- Additional Information
- Source: Publisher: Elsevier Country of Publication: United States NLM ID: 7603509 Publication Model: Print Cited Medium: Internet ISSN: 1528-0020 (Electronic) Linking ISSN: 00064971 NLM ISO Abbreviation: Blood Subsets: MEDLINE
- Publication Information: Publication: 2021- : [New York] : Elsevier
Original Publication: New York, Grune & Stratton [etc.] - Subject Terms:
- Abstract: Treatment results for patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-mutated (FLT3mut+) acute myeloid leukemia (AML) ineligible for intensive chemotherapy are disappointing. This multicenter, open-label, phase 3 trial randomized (2:1) untreated adults with FLT3mut+ AML ineligible for intensive induction chemotherapy to receive gilteritinib (120 mg/d orally) and azacitidine (GIL + AZA) or azacitidine (AZA) alone. The primary end point was overall survival (OS). At the interim analysis (August 26, 2020), a total of 123 patients were randomized to treatment (GIL + AZA, n = 74; AZA, n = 49). Subsequent AML therapy, including FLT3 inhibitors, was received by 20.3% (GIL + AZA) and 44.9% (AZA) of patients. Median OS was 9.82 (GIL + AZA) and 8.87 (AZA) months (hazard ratio, 0.916; 95% CI, 0.529-1.585; P = .753). The study was closed based on the protocol-specified boundary for futility. Median event-free survival was 0.03 month in both arms. Event-free survival defined by using composite complete remission (CRc) was 4.53 months for GIL + AZA and 0.03 month for AZA (hazard ratio, 0.686; 95% CI, 0.433-1.087; P = .156). CRc rates were 58.1% (GIL + AZA) and 26.5% (AZA) (difference, 31.4%; 95% CI, 13.1-49.7; P < .001). Adverse event (AE) rates were similar for GIL + AZA (100%) and AZA (95.7%); grade ≥3 AEs were 95.9% and 89.4%, respectively. Common AEs with GIL + AZA included pyrexia (47.9%) and diarrhea (38.4%). Gilteritinib steady-state trough concentrations did not differ between GIL + AZA and gilteritinib. GIL + AZA resulted in significantly higher CRc rates, although similar OS compared with AZA. Results support the safety/tolerability and clinical activity of upfront therapy with GIL + AZA in older/unfit patients with FLT3mut+ AML. This trial was registered at www.clinicaltrials.gov as #NCT02752035.
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- Accession Number: M801H13NRU (Azacitidine)
0 (gilteritinib)
0 (Pyrazines) - Publication Date: Date Created: 20220802 Date Completed: 20221031 Latest Revision: 20231119
- Publication Date: 20240628
- Accession Number: PMC10653009
- Accession Number: 10.1182/blood.2021014586
- Accession Number: 35917453
- Source:
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