Evidence map›Paper›PMID 40198272›Full record

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.

Naval Daver, Jayastu Senapati, Hagop M Kantarjian, Bofei Wang, Patrick K Reville, Sanam Loghavi, Musa Yilmaz, Courtney D DiNardo, Tapan M Kadia, Mhd Yousuf Yassouf and 16 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IMulticenter Study
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
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  8. Pandora's Box of AML: HowBiomedicines · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Naval Daver *Department of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-7103-373X
Jayastu Senapati *Department of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-6831-2567
Hagop M KantarjianDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1908-3307
Bofei WangDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-3651-6802
Patrick K RevilleDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-8433-3360
Sanam LoghaviDepartment of Cancer Medicine, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-8980-3202
Musa YilmazDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-4498-4895
Courtney D DiNardoDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-9003-0390
Tapan M KadiaDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9892-9832
Mhd Yousuf YassoufDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-7196-9503
Abhishek MaitiDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-9043-538X
Sankalp AroraDepartment of Hematopathology, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-8162-4119
Guillermo Montalban BravoDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-4533-5176
Guilin TangDepartment of Cancer Medicine, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9482-4806
Gautam BorthakurDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-7679-6453
Koji SasakiDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9140-0610
Naveen PemmarajuDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1670-6513
Joie AlvarezDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0009-0002-2716-7866
Graciela M Nogueras GonzalezDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-6350-2206
Jing NingDepartment of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-5289-331X
Ghayas C IssaDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-4339-8683
Marina KonoplevaDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9347-2212
Michael AndreeffDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1144-1958
Farhad RavandiDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-7621-377X
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-3631-2482
Hussein A AbbasDepartment of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-2946-3562

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
NovaSeq6000S10OD024977 · OD · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUFF, VICKI · 2018 to 2018
$995k
National Institutes of Health (NIH) 1S10OD024977-01NCI NIH HHS P30 CA016672NIH HHS S10 OD024977University of Texas MD Anderson Cancer Center (MD Anderson) CA01667University of Texas MD Anderson SPORE C1100632
6 · The paper itself

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.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsLeukemia, Myeloid, AcuteNeoplasm Recurrence, LocalAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAzacitidineBridged Bicyclo Compounds, HeterocyclicDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedSulfonamidesTumor Suppressor Protein p53Antibodies, Monoclonal, HumanizedAzacitidineBridged Bicyclo Compounds, HeterocyclicSulfonamidesTumor Suppressor Protein p53venetoclax

Identifiers

PMID40198272
PMCPMC12165814

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.