Phase 1/2 Study Tests Quizartinib/Venetoclax/Decitabine in FLT3-ITD AML
Musa Yilmaz, MD, discusses the most recent update of the phase 1/2 study of quizartinib, venetoclax, and decitabine in FLT3-internal tandem duplication mutated acute myeloid leukemia and the background behind this research.
Musa Yilmaz, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, discusses the most recent update of the phase 1/2 study (NCT03661307) of quizartinib (Vanflyta), venetoclax (Venclexta), and decitabine in FLT3-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML) and the background behind this research.
The study includes 2 cohorts, including 1 with newly diagnosed patients with AML and 1 with relapsed/refractory patients with AML. Quizartinib was given to patients at varying dose levels. Investigators found the recommended phase 2 dose to be 30 mg of quizartinib as it is well-tolerated and effective.
Updated findings were presented at the 2023 American Society of Hematology Annual Meeting.
Transcription:
0:09 | We presented a phase 1/2 clinical trial of decitabine, venetoclax, and quizartinib. This is not the first presentation, this is the update. Most importantly, we have now treated 14 patients with newly diagnosed FLT3-ITD mutated AML. Out of these 14 patients, all of them, 14, had a response. About 80% of these responses are complete remissions, and the remaining 20% are complete remissions with incomplete count recoveries.
0:43 | The standard-of-care treatment for the older patients who are not fit for intensive chemotherapy is either azacitidine or a hypomethylating agent in combination with venetoclax. We know that outcomes with this combo, in particular in patients with FLT3-ITD mutated AML, is about 10 months, the median overall survival. This is obviously poor and needs to be improved. Some of the preclinical studies have shown that combining a FLT3 inhibitor, such as crizotinib, with BCL2 inhibitor, such as venetoclax, has shown synergism and causes the death of the FLT3-positive cell lines. Also, preclinical models have shown that. Based on this rationale, we developed this phase 1/2 clinical study.
