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
ENHANCE-2: Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated AML
Patients with TP53-mutated AML have an extremely poor prognosis, highlighting an urgent unmet need for novel treatments. The phase III ENHANCE-2 trial (NCT04778397) evaluated the anti-CD47 monoclonal antibody magrolimab plus azacitidine (Mag+A) in patients with treatment-naive TP53-mutated AML.1 From July 2021 to May 2024, 257 patients were randomized.1 Patients ineligible for intensive therapy were randomized to receive Mag+A or venetoclax plus azacitidine (Ven+A); those eligible for intensive therapy were randomized to receive Mag+A or 7+3 induction chemotherapy. The primary endpoint was OS in the non-intensive arm. Findings from ENHANCE-2 were published in Blood by Zeidner et al.1
|
| Key learnings |
| At interim analysis, the OS HR for the non-intensive arm between treatment groups was 1.191 (95% CI, 0.744–1.906), meeting the study’s definition for futility and resulting in study termination. |
| At final analysis, the median OS was 4.4 months vs 6.6 months (HR, 1.132; 95% CI, 0.783–1.637; p = 0.5070) in the non-intensive arm and 7.3 months vs 11.1 months (HR, 1.434; 95% CI, 0.635–3.239; p = 0.3798) in the intensive arm between the Mag+A and control groups, respectively. |
| Incidences of Grade ≥3 AEs were comparable across the Mag+A and control groups (non-intensive, 96.9% vs 95.9%; intensive, 92.6% vs 95.7%), including Grade ≥3 anemia. Grade ≥3 infections occurred in 50.0% and 53.1% of patients in the non-intensive arm and 44.4% and 65.2% in the intensive arm. |
| Although ENHANCE-2 did not meet its primary endpoint of OS in TP53-mutated AML, findings from the trial highlight the poor outcomes with conventional therapies and the ongoing need for exploration of novel and combination therapies in this challenging population. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CI, confidence interval; HR, hazard ratio; Mag+A, magrolimab plus azacitidine; OS, overall survival; Ven+A, venetoclax plus azacitidine.
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
