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Association details:
| Biomarker: | FLT3-ITD mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Xospata (gilteritinib) (Multi-tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Gilteritinib plus azacitidine and venetoclax for FLT3-ITD mutated relapsed/refractory acute myeloid leukemia.
Published date:
05/25/2023
Excerpt:
We retrospectively analyzed the outcomes of gilteritinib plus azacitidine and venetoclax in 14 r/r FLT3-ITD mutated AML patients….At a median follow-up of 136.5 days, the median OS was 216.0 days, the median EFS was 97.0 days, and the median RFS were 184 days...the current data demonstrated promising response of the triple therapy in r/r FLT3-ITD mutated AML patients, and the regimen represented a potential option as a bridge to transplant.
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.2023.41.16_suppl.e19024
Source:
Title:
AZACITIDINE, VENETOCLAX AND GILTERITINIB FOR PATIENTS WITH NEWLY DIAGNOSED FLT3-MUTATED ACUTE MYELOID LEUKEMIA: A SUBGROUP ANALYSIS FROM A PHASE II STUDY
Published date:
05/11/2023
Excerpt:
The 1-year OS for patients with a FLT3-ITD mutation or FLT3-TKD mutation were 80% and 100%, respectively...The combination of azacitidine, venetoclax and gilteritinib is safe and effective in pts with FLT3-mutated AML.
Secondary therapy:
azacitidine
Source:
Title:
GILTERITINIB IN COMBINATION WITH VENETOCLAX, LOW DOSE CYTARABINE AND ACTINOMYCIN D FOR FLT3 MUTATED RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA
Published date:
05/12/2022
Excerpt:
Herein, we report the quadruplet regimen consisting of Gilteritinib, Venetoclax, Low Dose Cytarabine and Actinomycin D (ACTIVE + G) for the treatment of FLT3m R/R AML in the clinical practice setting….The CRc and the ORR were 67% (10/15) and 93% (14/15), respectively....The median OS and RFS were 8.6 and 12.9 months, respectively....A quadruplet regimen ACTIVE + G demonstrated high efficacy in this small group of R/R FLT3m AML patients irrespective of their prior exposure to FLT3 inhibitors or Venetoclax.
Secondary therapy:
cytarabine + dactinomycin
Source:
Title:
EFFICACY AND SAFETY OF VENETOCLAX IN COMBINATION WITH GILTERITINIB FOR RELAPSED/REFRACTORY FLT3-MUTATED ACUTE MYELOID LEUKEMIA: UPDATED ANALYSES OF A PHASE 1B STUDY
Published date:
05/12/2021
Excerpt:
...43 pts with FLT3mut+ had been enrolled. Median age (range) was 63 years (23–85). FLT3 internal tandem duplications (ITD) were identified in 37 pts (86%) and 6 pts (14%) had only tyrosine kinase domain (TKD) mutations...Ven + Gilt achieved high rates of mCRc in pts with heavily pretreated and prior TKI-exposed R/R FLT3mut+ AML with encouraging molecular clearance rates.
Source:
Title:
333 Efficacy and Safety of Venetoclax in Combination with Gilteritinib for Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia in the Expansion Cohort of a Phase 1b Study
Published date:
11/04/2020
Excerpt:
mCRc was achieved by 83.8% of pts...Ven plus Gilt achieved a very high overall rate of marrow and blood blast elimination and mCRc rate (84%) in this expansion cohort of heavily pretreated FLT3mut+ pts...
Trial ID:
Source:
Title:
Inhibition of Bcl-2 Synergistically Enhances the Antileukemic Activity of Midostaurin and Gilteritinib in Preclinical Models of FLT3-Mutated Acute Myeloid Leukemia
Published date:
11/15/2019
Excerpt:
The combination of midostaurin or gilteritinib with venetoclax potently and synergistically induces apoptosis in FLT3-ITD AML cell lines and primary patient samples.
DOI:
10.1158/1078-0432.CCR-19-0832
