Biomaterial Database

Gilteritinib with or without venetoclax for relapsed/refractory FLT3-mutated acute myeloid leukaemia. 2024

Eitan Kugler, and Inbar Cohen, and Irina Amitai, and Ron Ram, and Avraham Frisch, and Boaz Nachmias, and Jonathan Canaani, and Yakir Moshe, and Baher Krayem, and Shlomzion Aumann, and Israel Henig, and Vladimir Vainstein, and Liat Shargian, and Chezi Ganzel, and Moshe Yeshurun, and Itay Levi, and Pia Raanani, and Luiza Akria, and Yishai Ofran, and Shai Shimony, and Ofir Wolach

Institute of Haematology, Davidoff Cancer Center, Rabin Medical Center-Beilinson Hospital, Petach Tikva, Israel.

Patients with FLT3-mutated acute myeloid leukaemia (AML) that relapse or are refractory (R/R) to intensive induction have poor outcomes. Gilteritinib has recently become standard-of-care for patients with R/R FLT3-mutated AML. We investigated whether adding venetoclax to gilteritinib (gilt-ven) improves outcomes as compared with gilteritinib monotherapy. We included patients treated with gilteritinib (n = 19) and gilt-ven (n = 17) for R/R AML after intensive chemotherapy. Gilteritinib and gilt-ven groups did not differ in terms of mCRc rates (53% and 65%, p = 0.51) and realization of allogeneic haematopoietic stem-cell transplantation (HSCT, 47% and 35%, p = 0.5). Overall survival (OS) was comparable between groups, although a trend towards better OS was seen with gilt-ven (12-month OS 58.8% [95% CI 39.5%-87.6%]) versus gilteritinib (42.1% [95% CI 24.9%-71.3%] for gilteritinib). Early salvage with gilt-ven versus any other gilteritinib-based approach was associated with the best outcome (p = 0.031). Combination therapy was associated with increased haematological toxicity. In summary, gilt-ven did not improve remissions or HSCT-realization rates in patients with R/R FLT3-mutated AML as compared with gilteritinib and was associated with increased haematological toxicity. Although OS did not differ, a trend towards better survival was suggested with gilt-ven and a survival benefit was shown for gilt-ven approach when sequenced early for salvage.