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2024-09-23T15:20:05.000Z

Iadademstat + azacitidine in adult patients with newly diagnosed AML: The phase IIa ALICE study

Sep 23, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in acute myeloid leukemia.

Results from the open-label, dose-finding, phase IIa ALICE study (EudraCT 2018-000482-36) assessing iadademstat, a LSD1 inhibitor, in combination with azacitidine in patients with ND AML who were ineligible for intensive chemotherapy were published in The Lancet Haematology by Salamero et al.A total of 36 patients in Spain with intermediate- or adverse-risk AML were included, with a median follow-up of 22 months. The median age was 76 years and 50% of patients were female.1

Key learnings
Treatment-related AEs occurring in ≥10% patients included thrombocytopenia (69%), neutropenia (61%), anemia (42%), dysgeusia (42%), constipation (25%), asthenia (25%), nausea (17%), and reduced appetite (11%). Three treatment-related SAEs were observed; a fatal Grade 5 intracranial hemorrhage, a Grade 3 febrile neutropenia, and a Grade 3 differentiation syndrome. Of the 12 deaths due to AEs, one was related to treatment and caused by intracranial hemorrhage.
Objective response was achieved by 82% of patients in the efficacy set (n = 27). Among these, 52% patients had CR/CRh and 10 of 11 evaluable patients achieved MRD negativity. In the safety set (n = 36), 61% achieved objective response, with 39% reaching CR/CRh. 
Iadademstat 90 μg/m² per day combined with azacitidine was selected as the recommended phase II dose.
The combination of iadademstat and azacitidine demonstrated deep responses with a manageable safety profile in patients with ND AML, including those with high-risk features. However, further studies are needed to confirm its activity.

Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CR, complete remission; CRh, complete remission with incomplete hematologic recovery; LSD1, lysine-specific demethylase 1; MRD, measurable residual disease; ND, newly diagnosed; SAE, serious AE. 

  1. Salamero O, Molero A, Pérez-Simón JA, et al. Iadademstat in combination with azacitidine in patients with newly diagnosed acute myeloid leukaemia (ALICE): An open-label, phase 2a dose-finding study. Lancet Haematol. 2024;11(7):e487- DOI: 10.1016/S2352-3026(24)00132-7

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