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Submitted:
29 April 2023
Posted:
29 April 2023
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Response data | |
---|---|
Overall Response in FLT3 mutated AML1 (n=247)
|
67.7 34 21.1 26.7 11 |
Rate of response in FLT3 mutated AML previously treated with TKIs7 (n=33)
|
17 8.9 57 47 3.7 12.9 |
Rate of response in FLT3 mutated AML1 by baseline co-mutations (n=239)
|
29 17.2 12.8 20 28.6 27 29.3 30.9 13.3 28.2 |
Outcomes data | |
Outcomes of FLT3 mutated AML1 (n=247)
|
9.3 36.6 20.6 15.8 52.6 75.7 |
Outcomes of FLT3 mutated AML1 according to previous TKIs7 therapy
|
9.5 8.7 |
Overall survival in FLT3 mutated AML by baseline co-mutations (n=239)
|
11.4 9.6 7.1 4.6 10.6 8.6 11 15.1 8.3 15.4 |
Outcomes of FLT3 mutated AML1 according FLT3-ITD length, multiple FLT3-ITD mutations and FLT3-ITD allelic ratio
|
10.4 8.9 9.3 7.1 10.6 |
Reference | Number of patients | Composite complete remission | Median overall survival | Comment |
---|---|---|---|---|
Dumas et al.21 | 140 (cohort B) 67 previously treated by intensive chemotherapy and midostaurin (cohort C) |
25.4% (cohort B) 27.5% (cohort C) |
6.4 months (cohort B) 7.8 months (cohort C) |
prognostic factors associated with OS identified female gender (HR 1.61), adverse cytogenetic risk (HR 2.52), and allogenic transplant after gilteritinib (HR 0.13) |
Othman et al.22 | 50 (86% received previous intensive chemotherapy) | 27% | 6.7 months (95%CI 4.5 - not reached) | the rate of composite complete response did not differ in those with previous exposure to FLT3 inhibitors (23% vs 32%, p=0.6) or with past allogeneic transplant (29% vs 27%, p=0.3) |
Numan et al.23 | 113 (62.8% received gilteritinib as monotherapy, while the remaining patients received gilteritinib in combination with other agents) | 48.7% | 7.4 months for transplant group 7.1 months for none-transplant 7.8 months in patients treated with prior midostaurin 5 months in patients treated with prior sorafenib |
The presence of PTPN11 and NRAS had a significant inferior impact on composite complete remission rate (59% vs. 37.5%) and median overall survival (4.9 months vs. 7.8 months; HR 2.4–95% CI 1. 1–5.4 -p = .0057) |
Shimony et al.24 | 25 (80% treated with prior intensive chemotherapy and 40% previously treated with tyrosine kinase inhibitor therapy) | 48% | 8 months | Prior tyrosine kinase inhibitor exposure did not negatively impact on overall survival and was associated with superior event-free survival (p = 0.016) |
Number of the study | Protocol regimen | Eligible patients |
---|---|---|
NCT04027309 | gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance | newly diagnosed acute myeloid leukemia or myelodysplastic syndromes with excess blasts-2 with FLT3 mutations |
NCT04140487 | azacitidine, venetoclax, and gilteritinib | relapsed/refractory FLT3-mutated acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/myeloproliferative neoplasm |
NCT04240002 | gilteritinib combined with chemotherapy | children, adolescents and young adults FLT3-ITD positive relapsed/refractory acute myeloid leukemia |
NCT05546580 | iadademstat and gilteritinib | relapsed/refractory acute myeloid leukemia with FLT3-ITD mutation |
NCT05520567 | gilteritinib, venetoclax and azacitidine | newly diagnosed with acute myeloid leukemia with FLT3 mutations |
NCT05028751 | lanraplenib (lanra) in combination with gilteritinib | FLT3 mutated relapsed/refractory acute myeloid leukemia |
NCT05010122 | astx727, venetoclax, and gilteritinib | newly Diagnosed, relapsed/refractory FLT3-Mutated acute myeloid leukemia or high-risk myelodysplastic syndrome |
NCT04293562 | standard chemotherapy versus therapy with cpx-351 and/or gilteritinib | newly diagnosed acute myeloid leukemia with or without FLT3 Mutations |
NCT05010772 | decitabine alone or in combination with venetoclax, gilteritinib, enasidenib, or ivosidenib as maintenance therapy | acute myeloid leukemia in remission |
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