Evidence map›Paper›PMID 40233321›Full record

Trial reportBlood2025

The ENHANCE-3 study: venetoclax and azacitidine plus magrolimab or placebo for untreated AML unfit for intensive therapy.

Naval Daver, Paresh Vyas, Gerwin Huls, Hartmut Döhner, Sébastien Maury, Jan Novak, Cristina Papayannidis, Carmen Martínez Chamorro, Pau Montesinos, Rabin Niroula and 12 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Blood, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05079230 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy), which is not on this map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
–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.

NCT05079230 phase3terminatednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

TypeinterventionalSponsorGilead SciencesRan2022 to 2024Enrolled378ConditionsAcute Myeloid LeukemiaArmsMagrolimab, Venetoclax, Azacitidine, Placebo
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. Recent advances in the regulation of CD47 by non-coding RNAs and its therapeutic potential in cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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  10. Targeting CD24 Activates Macrophages to Reduce Tumor Burden in Preclinical Models of Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Naval DaverDepartment of Leukemia, MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-7103-373X
Paresh VyasMRC Molecular Haematology Unit, Weatherall Institute of Molecular Medicine, Radcliffe Department of Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.ORCID 0000-0003-3931-0914
Gerwin HulsDepartment of Hematology, Universitair Medisch Centrum Groningen, Groningen, The Netherlands.
Hartmut DöhnerDepartment of Internal Medicine III, Ulm University Hospital, Ulm, Germany.ORCID 0000-0003-2116-5536
Sébastien MauryHematology Department, Hôpitaux Universitaires Henri Mondor, Créteil, France.ORCID 0000-0002-1170-8683
Jan NovakDepartment of Hematology, Fakultní Nemocnice Královské Vinohrady, Prague, Czech Republic.ORCID 0000-0003-1241-1635
Cristina PapayannidisIRCCS Azienda Ospedaliero Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," Bologna, Italy.ORCID 0000-0001-8705-8333
Carmen Martínez ChamorroHematology Department, Hospital Universitario Quirónsalud Madrid and Universidad Europea de Madrid, Madrid, Spain.
Pau MontesinosDepartment of Hematology, Hospital Universitario La Fe, Valencia, Spain.ORCID 0000-0002-3275-5593
Rabin NiroulaDivision of Hematology-Oncology, Rhode Island Hospital, Providence, RI.
Pierre FenauxDepartment of Hematology, Hôpital Saint-Louis, Paris, France.
Jordi EsteveDepartment of Hematology, Hospital Clinic de Barcelona, Barcelona, Spain.
Shang-Ju WuDepartment of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0002-0772-869X
Adrien De VoeghtDepartment of Medicine, Centre Hospitalier Universitaire de Liège Site Sart Tilman, Liège, Belgium.ORCID 0000-0003-3727-5190
Jiri MayerDepartment of Internal Medicine-Hematology and Oncology, Faculty Hospital Brno and Masaryk University, Brno, Czech Republic.
Peter J M ValkDepartment of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Lisa JohnsonGilead Sciences, Inc, Foster City, CA.ORCID 0000-0002-2019-6560
Mei DongGilead Sciences, Inc, Foster City, CA.
Ke LiuGilead Sciences, Inc, Foster City, CA.
Sowmya KuwaharaGilead Sciences, Inc, Foster City, CA.
Kenneth CaldwellGilead Sciences, Inc, Foster City, CA.
Guru Subramanian Guru MurthyDivision of Hematology and Oncology, Froedtert and Medical College of Wisconsin, Milwaukee, WI.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractPatients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy (IC) have limited treatment options. The phase 3 ENHANCE-3 study aimed to determine whether magrolimab (magrolimab arm) was superior to placebo (control arm) when either was combined with venetoclax and azacitidine. Adults with previously untreated AML who were ineligible for IC were randomized to receive magrolimab (1 mg/kg on days 1 and 4, 15 mg/kg on day 8, 30 mg/kg on days 11 and 15, then weekly for 5 weeks, and then every 2 weeks) or placebo, venetoclax (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter), and azacitidine (75 mg/m2 days 1-7) in 28-day cycles. The primary end point was overall survival (OS); key secondary end points included complete remission (CR) rate and safety. After randomization of 378 patients, the trial was stopped at a prespecified interim analysis owing to futility. At final analysis, with median follow-up of 7.6 months (magrolimab arm) vs 7.4 months (control arm), median OS was 10.7 vs 14.1 months (hazard ratio, 1.178; 95% confidence interval, 0.848-1.637). The CR rate within 6 cycles was 41.3% vs 46.0%. Addition of magrolimab to venetoclax and azacitidine resulted in more fatal adverse events (19.0% vs 11.4%), primarily driven by grade 5 infections (11.1% vs 6.5%) and respiratory events (2.6% vs 0%). There were similar incidences of any-grade infections, febrile neutropenia, and neutropenia between arms. These results highlight the difficulty in improving outcomes for patients with AML who were ineligible for IC. This trial was registered at www.clinicaltrials.gov as #NCT05079230.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineLeukemia, Myeloid, AcuteAdultAgedAged, 80 and overBridged Bicyclo Compounds, HeterocyclicDouble-Blind MethodFemaleHumansMaleMiddle AgedSulfonamidesAntibodies, Monoclonal, HumanizedAzacitidineBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclax

Identifiers

PMID40233321
PMCPMC12824654

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Registered trials

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.