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

Objectives: To 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). Methods: We 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. Results: Thirty‐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. Conclusion: VEN–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. [ABSTRACT FROM AUTHOR]