The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View aml content recommended for you
Iadademstat + azacitidine in adult patients with newly diagnosed AML: The phase IIa ALICE study
|
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.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
Your opinion matters
Approximately what proportion of your patients with FLT3-mutations also have NPM1 and DNMT3A co-mutations?
