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EHA 2025 | Phase I/II trial of decitabine, venetoclax, and quizartinib in newly diagnosed FLT3-ITD–mutated AML
Musa Yilmaz, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, comments on the efficacy of a triplet combination of decitabine, venetoclax, and quizartinib in patients with newly diagnosed FLT3-ITD–mutated acute myeloid leukemia (AML). An ongoing Phase I/II study of this regimen has demonstrated promising results, with a significant proportion of patients achieving a composite complete response (CRc) and measurable residual disease (MRD) negativity. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
So this is a Phase I and II study of the decitabine, venetoclax, and quizartinib triplet combination in FLT3 ITD-mutated AML. So in this study we treated both frontline patients, newly diagnosed patients, and also relapsed/refractory patients. So in the frontline arm, for the sake of time and brevity, let’s focus on the frontline arm. So we have treated 30 patients in the newly diagnosed cohort and these are the patients with the median age of 74 years old...
So this is a Phase I and II study of the decitabine, venetoclax, and quizartinib triplet combination in FLT3 ITD-mutated AML. So in this study we treated both frontline patients, newly diagnosed patients, and also relapsed/refractory patients. So in the frontline arm, for the sake of time and brevity, let’s focus on the frontline arm. So we have treated 30 patients in the newly diagnosed cohort and these are the patients with the median age of 74 years old. So those are the patients that are not eligible for intensive chemotherapy, that’s why they are on this program. So they have received this triplet combination in the Phase I and Phase II component, but mostly Phase II. The recommended Phase II dose for the quizartinib of this triplet is 30 milligrams. We have tried up to 40 but it created prolonged cytopenias in these patients, that’s why we had to reduce the dose to 30. So, quizartinib 30 milligrams, venetoclax, and decitabine.
So with this induction regimen, 94% of the patients achieved composite CR, and 70% achieved complete remissions, meaning complete bone marrow remission plus counts recovering to normal ranges. So also we have looked at MRD in these patients, minimal residual disease by flow and also PCR. And we have seen after cycle one, 60% of the patients achieved MRD negativity, and with the following cycles, the MRD negativity got even better up to 80%.
The second point that we, the second important key point from this study is that the overall survival in the newly diagnosed cohort, the median overall survival is not reached. And the median follow-up is 17 months and one-year overall survival was 72%, which is pretty good compared to the patients who receive only HMA-VEN or only HMA plus FLT3 inhibitor, which is usually less than one year. I’m specifically talking about FLT3 ITD-mutated patients. So that study shows that we can improve survival in this patient population.
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