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Rebecca Olin, MD, MS


ASCO 2022: Potential Triplet Regimen Under Study in FLT3-ITD–Mutated AML

By: Vanessa A. Carter, BS
Posted: Tuesday, June 14, 2022

A phase I/II clinical trial, conducted by Musa Yilmaz, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues, assessed the efficacy and safety of the FLT3 inhibitor quizartinib combined with decitabine and venetoclax in patients with FLT3-ITD–mutated acute myeloid leukemia (AML). Presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7036), the results of this study suggest activity with this treatment combination in relapsed or refractory, FLT3-ITD–mutated AML.

“Interestingly, RAS/MAPK mutations—but not emergent tyrosine kinase domain mutations—were associated with primary and secondary resistance to the triplet,” stated the study authors.

A total of 28 patients with either newly diagnosed (n = 5) or relapsed/refractory (n = 23) AML were enrolled. Participants were administered decitabine for 10 days, underwent a bone marrow biopsy on day 14, and received venetoclax for 21 days upon demonstrating a bone marrow blast count higher than 5%. Quizartinib was continuously administered daily, and decitabine was reduced to 5 days in subsequent cycles.

All five patients with newly diagnosed AML achieved a complete response; four and two individuals were FTL3-polymerase chain reaction– and multicolor flow cytometry–negative, respectively. Hematologic dose-limiting toxicities were reported in two patients receiving 40 mg/day of quizartinib; therefore, the 30 mg/day dose was deemed as the recommended phase II dose.

The most common grade 3 or 4 toxicities included neutropenic fever and lung infections. At the median follow-up of 13 months, the median overall survival for those with relapsed/refractory disease was 7.6 months. Of the 18 patients with relapsed/refractory disease who responded, 8 underwent autologous stem cell transplantation; the median overall survival was 19 months. Additionally, the median overall survival among the five front-line responding patients was 14.5 months.

Disclosure: For full disclosures of the study authors, visit

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