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Iadademstat + azacitidine in adult patients with newly diagnosed AML: The phase IIa ALICE study
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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.1 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.
- 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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