Azacitidine–venetoclax versus azacitidine salvage treatment for primary induction failure or first relapsed acute myeloid leukaemia patients

Abstract

ObjectivesTo compare the efficacy of venetoclax‐azacitidine (VEN–AZA) with AZA in the real‐life for patients with first relapsed or refractory acute myeloid leukaemia (R/R AML).MethodsWe retrospectively analysed R/R AML patients treated with VEN–AZA at the Institut Paoli Calmettes between September 2020 and February 2022. We compared them to a historical cohort of patients treated with AZA between 2010 and 2021.ResultsThirty‐five patients treated with VEN–AZA were compared with 140 patients treated with AZA. There were more favourable cytogenetics (25.7% vs. 8.6%; p = 0.01) and less FLT3‐ITD mutated AML (8.8% vs. 25.5%; p = .049) in the VEN–AZA group. The overall 30‐day mortality rate was 7.4% and the overall 90‐day mortality was 20%, with no difference between the groups. The complete remission rate was 48.6% in the VEN–AZA group versus 15% (p < .0001). The composite complete response rate was 65.7% in the VEN–AZA group versus 23.6% (p < .0001). OS was 12.8 months in the VEN–AZA group versus 7.3 months (p = 0.059). Patients with primary refractory AML, poor‐risk cytogenetics, prior hematopoietic stem‐cell transplantation (HSCT) and FLT3‐ITD mutated AML had lower response and survival rates.ConclusionVEN–AZA was associated with a better response rate and a longer survival than AZA monotherapy in AML patients who relapsed after or were refractory to intensive chemotherapy.

Case report: Donor-derived CLL-1 chimeric antigen receptor T-cell therapy for relapsed/refractory acute myeloid leukemia bridging to allogeneic hematopoietic stem cell transplantation after remission

“…However, the disease status at the time of allo-HSCT was closely related to the outcome after HSCT. Allo-HSCT is most effective in patients who reached CR with the lowest relapse rate since there is sufficient time to establish a strong graft-versus-leukemia (GVL) effect in such cases ( 2 , 3 ). Therefore, immediate salvage allo-HSCT was not the optimal choice for this patient.…”

“…Relapsed/refractory acute myeloid leukemia (R/R AML) has a low remission rate with chemotherapy and a high probability of relapse after salvage HSCT has been performed in the absence of remission (1)(2)(3). Therefore, it is challenging to regain remission before HSCT to achieve good conditions for successful hematopoietic stem cell transplantation (HSCT) and reduce the risk of subsequent relapse.…”

Venetoclax Resistance in Acute Myeloid Leukemia

“…The VEN-AZA regimen was approved for unfit or older AML patients in France and in most European countries in 2020. Since then, real-life experiences have confirmed the high response rate of VEN-AZA treatment in the context of newly diagnosed AML as well as refractory AML [ 23 , 24 , 25 , 26 ]. The main clinical studies published on VEN-HMA are summarized in Table 1 .…”