Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025
Azacitidine, Venetoclax, and Magrolimab in Newly Diagnosed and Relapsed Refractory Acute Myeloid Leukemia: Phase Ib/II Study and Correlative Analysis.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed.
- Current and future therapies for acute myeloblastic leukemia.Journal of hematology & oncology · 2026Review
- Immune Checkpoints in Leukaemia as Gatekeepers of Immuno-Modulation.Immunology · 2026Review
- Venetoclax for elderly patients with acute myeloid leukaemia unfit for intensive chemotherapy: Prospects, resistance mechanisms and management strategies.Clinical and translational medicine · 2026Review
- Epigenetic Regulation in Acute Myeloid Leukemia: Molecular Mechanisms and Clinical Implications.Cancers · 2026Review
- Immunotherapy in acute myeloid leukemia: The antibodies, TriKEs, and CARs on the arduous road to cure.Blood reviews · 2026Review
- Integrating Targeted Therapies into AML Frontline Therapy: Who Gets What and What Does the Future Hold?Cancers · 2026Review
- Antibody therapies in glioblastoma: Overcoming micro-environmental barriers.Iranian journal of basic medical sciences · 2026Review
- Pandora's Box of AML: HowBiomedicines · 2025Review
- Overexpressed CD24 and CD47 Indicate a Worse Prognosis in Cervical Cancer.Cancer medicine · 2025Article
- IGSF9-targeted therapy inhibits the progression of acute myeloid leukemia.Blood advances · 2025Article
- Contemporary outcomes of octa-nonagenarians with newly diagnosed acute myeloid leukemia.Cancer · 2025Article
Corrections and comments
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Authors and funding
26 authors.
Funding
Abstract
purposeMagrolimab is a monoclonal antibody directed against the macrophage checkpoint CD47 on myeloid leukemia cells that was preclinically synergistic with azacitidine-venetoclax, warranting further clinical evaluation. PATIENTS AND
methodsIn this phase Ib/II study, the triplet combination of azacitidine, venetoclax, and magrolimab was evaluated in adult patients with first-line (ineligible for intensive chemotherapy) and relapsed/refractory acute myeloid leukemia. Azacitidine was dosed at 75 mg/m2 for 7 days, venetoclax at 400 mg/day for 28 days, and magrolimab (recommended phase II dose) as follows: 1 mg/kg dose on days 1 and 4, 15 mg/kg on day 8, and 30 mg/kg on days 11, 15, and 22 (cycle 1), followed by 30 mg/kg weekly for cycle 2 and then 30 mg/kg every 2 weeks for cycle 3 and beyond. The primary endpoint was the recommended phase II dose for phase Ib and rates of composite complete response (CRc) in phase II.
resultsThe first-line cohort included 54 patients (median age 70.1 years); 35 (64.8%) were TP53 mutated (TP53mut). CRc was attained in 34 patients (63%)-49% in TP53mut and 90% in the TP53 wild-type patients. At a median follow-up of 27.9 months, the median event-free survival and overall survival (OS) were 6.6 and 9.8 months, respectively; for TP53mut patients, the median event-free survival and OS were 5.9 and 7.6 months, whereas for TP53 wild type, they were 9.6 and 13 months, respectively. CRc in the relapsed/refractory cohort (n = 52) was 29% and the median OS was 3.9 months. The regimen was well tolerated; infections were the most common ≥ grade 3 adverse event (75.4%) with no immune toxicities or deaths related to therapy. Single-cell RNA sequencing was performed on 27 longitudinal samples from 11 TP53mut patients (eight responders). Gene set enrichment analysis revealed enrichment of IFNγ and TNFα signaling in nonresponders at baseline, whereas erythroid differentiation was associated with resistance. Patients at relapse also showed upregulated CD47 expression and elevated leukemia regeneration score.
conclusionsThe triplet regimen was safe but did not lead to promising survival outcomes.
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