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Azacitidine plus venetoclax is the standard-of-care treatment for patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy; however, patients with FLT3-mutated AML may be resistant to this treatment.1 The triple combination of azacitidine, venetoclax, and gilteritinib, an FLT3 inhibitor, may improve outcomes in this patient population.1 Here, we summarize results from a single center phase I/II trial (NCT04140487) evaluating the safety and efficacy of this triplet combination in patients with newly diagnosed and relapsed/refractory (R/R) FLT3-mutated AML, published by Short et al.1 in Journal of Clinical Oncology.
Figure 1.
Response rates in the first-line and R/R cohorts*
CR, complete remission; CRi, CR with incomplete hematologic recovery; MLFS, morphologic leukemia-free state; PR, partial remission; R/R, relapsed/refractory.
*Data from Short, et al.1
Table 1. MRD response in the first-line and R/R cohorts*
C1, Cycle 1; FLT3, FMS‐like tyrosine kinase 3; MRD, measurable residual disease; PCR, polymerase chain reaction; R/R, relapsed/refractory. |
||
MRD response, % (unless otherwise specified) |
First-line cohort |
R/R cohort |
---|---|---|
MRD by flow cytometry (after C1), n |
16 |
9 |
Negative |
56 |
11 |
Positive |
44 |
89 |
MRD by flow cytometry (best response), n |
27 |
11 |
Negative |
93 |
45 |
Positive |
7 |
55 |
MRD by PCR for FLT3 (after C1), n |
30 |
11 |
Negative |
37 |
27 |
Positive |
63 |
73 |
MRD by PCR for FLT3 (best response), n |
30 |
14 |
Negative |
90 |
43 |
Positive |
10 |
57 |
Figure 2. 6-, 12-, and 18-month RFS and OS rates in the first-line cohort*
OS, overall survival; RFS, relapse-free survival.
*Data from Short, et al.1
|
References
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