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Mutation testing in AML:
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ENHANCE-2: Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated AML
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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.
- Zeidner J, Sallman D, Récher C, et al. Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated acute myeloid leukemia: the ENHANCE-2 study. Blood. 2025. Online ahead of print. DOI: 10.1182/blood.2024027408
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