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    Home > Active Ingredient News > Blood System > 2021 EBMT | Venecla combined with hypomethylation drugs is safe and effective in the treatment of high-risk AML, which can effectively bridge transplantation

    2021 EBMT | Venecla combined with hypomethylation drugs is safe and effective in the treatment of high-risk AML, which can effectively bridge transplantation

    • Last Update: 2021-03-22
    • Source: Internet
    • Author: User
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    Patients with high-risk acute myeloid leukemia (HR-AML) and elderly AML have cytogenetic factors with a poor prognosis and a high probability of comorbidities.

    These patients do not respond well to induction therapy, and the prognosis is worse than that of patients with relapsed and refractory (R/R) AML.

    Veneclax is a highly selective Bcl-2 inhibitor, combined with hypomethylation drugs (HMA) to demonstrate anti-leukemia activity without additional adverse reactions.

    This study explored the efficacy and safety of Veneclax combined with HMA in the treatment of newly treated AML and R/R AML, and also evaluated the role of this regimen in bridging transplantation.

    The results of the study will be announced at the 47th Annual Meeting of the European Association of Blood and Bone Marrow Transplantation (EBMT 2021) in 2021.

    The editor organizes the main content as follows for the reference of readers.

    01 Research method The study included 24 patients from October 2018 to October 2020, with a median age of 69 years (range: 27-80 years).

    Fourteen patients (60%) had untreated AML or had poor/complex cytogenetic characteristics, and 10 patients (40%) had R/R AML.

    Among R/RAML patients, 3 cases had relapse after HMA treatment, 5 cases had relapse after induction treatment, and 2 cases had relapse after allogeneic transplantation.

    The study included patients who received 400 mg of Veneclair per day, of which 15 patients (63%) received Decitabine 20 mg/m2 on days 1-5 of each treatment cycle (28-day cycle), and 9 patients (37%) Patients received azacitidine 75 mg/m2 on days 1-7 of each treatment cycle.

    A median of the patients in the study received 3 cycles (range: 1-19) of Venecla combined with HMA.

    02 Results of the study The compound complete remission rate (CR+CRi) of AML patients included in the study was 60%, of which the compound complete remission rate of newly-treated AML patients was 75%, and the compound complete remission rate of R/R AML patients was 50%.

    The median time to remission in both groups was 2 months (range: 1-5), and there were no deaths in the induction treatment phase.

    At a median follow-up of 5 months (range: 1-22), 14 of the 24 patients (58%) were alive, of which 5 (21%) patients were still receiving treatment or were in complete remission.

    Ten patients (42%) died, and the main cause of death was disease progression.

    After a median of 3 cycles (range: 3-4) of Venecla and HMA regimen treatment, 9 patients (6 cases of R/R AML, 3 cases of naive AML) received allogeneic hematopoietic stem cell transplantation (6 cases) Haplotype, 1 matched related donor, 2 MUD).

     The most common grade 3-4 hematological adverse events in the study were anemia (58%), thrombocytopenia (45%), leukopenia (62%) and granulocytopenic fever (31%).
    No 3- Grade 4 non-hematological adverse events.

    There was no statistically significant difference in OS between R/R AML patients and newly-treated AML patients (11.
    7 months vs 11.
    9 months; P=0.
    527).
    The median OS of transplanted patients was better than that of non-transplanted patients (9.
    7 Months vs 3.
    0 months; P=0.
    001).

    At a median follow-up of 13 months (range: 2.
    2-22.
    0), all transplanted patients were alive and in CR status.

    03Research conclusions There are challenges in the treatment of HR-AML, R/R AML and elderly AML patients.

    The combination of Venecla and HMA achieves a high remission rate in this part of AML patients, while being safe and effective.

    Nearly half of the patients in the study have received transplantation, which is an ideal solution for AML bridging transplantation.

    Reference source: V.
    Federico, M.
    Dargenio, R.
    Matera, et al.
    Venetoclax combined with hypomethylating agent(HMA) is safe and effective may be a goodbridge to transplant in high-risk acute myeloid leukemia.
    The 47th Annual Meeting of the EBMT.
    Abstract OS17-5.
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