Evidence map›Paper›PMID 40009500›Full record

Trial reportBlood2025

Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated acute myeloid leukemia: the ENHANCE-2 study.

Joshua F Zeidner, David A Sallman, Christian Récher, Naval G Daver, Anskar Y H Leung, Devendra K Hiwase, Marion Subklewe, Thomas Pabst, Pau Montesinos, Richard A Larson 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 NCT04778397 (A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia), which is not on this map. Cited by 49 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing 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.

NCT04778397 phase3terminatednot on this map

A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia

TypeinterventionalSponsorGilead SciencesRan2021 to 2024Enrolled258ConditionsAcute Myeloid LeukemiaArmsMagrolimab, Venetoclax, Azacitidine, Cytarabine, Daunorubicin
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Treatment ofHaematologica · 2026
    Trial
  3. Azacitidine, Venetoclax, and Magrolimab in Newly Diagnosed and Relapsed Refractory Acute Myeloid Leukemia: Phase Ib/II Study and Correlative Analysis.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  4. Article
  5. Article
  6. 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
    Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Lenalidomide Exposure andCurrent oncology (Toronto, Ont.) · 2026
    Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Joshua F ZeidnerDivision of Hematology, Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC.ORCID 0000-0002-9014-1514
David A SallmanDepartment of Malignant Hematology, Moffitt Cancer Center, Tampa, FL.ORCID 0000-0003-0504-8233
Christian RécherLe Departement d'Hematologie, Institut Universitaire du Cancer de Toulouse Oncopole, Centre Hospitalier Universitaire de Toulouse, Université de Toulouse III Paul Sabatier, Toulouse, France.ORCID 0000-0002-3332-4525
Naval G DaverDepartment of Leukemia, MD Anderson Cancer Center, The University of Texas Houston, Houston, TX.ORCID 0000-0001-7103-373X
Anskar Y H LeungDepartment of Medicine, Queen Mary Hospital, The University of Hong Kong-Shenzhen Hospital and Hong Kong Sanatorium and Hospital, Hong Kong SAR, China.
Devendra K HiwaseMyelodysplastic Syndromes Research Group, Royal Adelaide Hospital, Adelaide, SA, Australia.
Marion SubkleweDepartment of Medicine III, Klinikum, Campus Großhadern, Ludwig Maximilian University of Munich, Munich, Germany.ORCID 0000-0003-3905-0251
Thomas PabstDepartment of Medical Oncology, University Clinic for Medical Oncology, Inselspital University Hospital Bern, Bern, Switzerland.ORCID 0000-0002-6055-5257
Pau MontesinosDepartment of Hematology, Hospital Universitari I Politecnic La Fe, Valencia, Spain.ORCID 0000-0002-3275-5593
Richard A LarsonDepartment of Medicine and Comprehensive Cancer Center, The University of Chicago, Chicago, IL.ORCID 0000-0001-9168-3203
Lindsay WildeDivision of Hematologic Malignancies, Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA.
Anoop K EnjetiDepartment of Haematology, Calvary Mater Newcastle Hospital, Waratah, Newcastle, NSW, Australia.
Ichiro KawashimaDepartment of Hematology and Oncology, University of Yamanashi Hospital, Yamanashi, Japan.ORCID 0000-0002-2242-1266
Cristina PapayannidisIstituto di Ematologia "Seragnoli," Istituto di Ricovero e Cura a Carattere Scientifico, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.ORCID 0000-0001-8705-8333
Jenny O'NionsDepartment of Haematology, University College London Hospitals National Health Services Foundation Trust, London, United Kingdom.
Lisa JohnsonGilead Sciences, Inc, Foster City, CA.ORCID 0000-0002-2019-6560
Mei DongGilead Sciences, Inc, Foster City, CA.
Julie HuangGilead Sciences, Inc, Foster City, CA.
Taravat BagheriGilead Sciences, Inc, Foster City, CA.
Gal Hacohen KleimanGilead Sciences, Inc, Foster City, CA.
Calvin LeeGilead Sciences, Inc, Foster City, CA.
Paresh VyasMedical Research Council Molecular Haematology Unit, Weatherall Institute of Molecular Medicine, Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-3931-0914

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractPatients with TP53-mutated acute myeloid leukemia (AML) have an extremely poor prognosis, necessitating new treatments. The global, randomized, phase 3 ENHANCE-2 trial evaluated the anti-CD47 monoclonal antibody magrolimab plus azacitidine (Magro/Aza) for previously untreated TP53-mutated AML. Patients determined ineligible for intensive therapy were randomized to receive Magro/Aza or venetoclax plus Aza (Ven/Aza); those eligible for intensive therapy were randomized to receive Magro/Aza or 7+3 induction chemotherapy. The primary end point was overall survival (OS) in the nonintensive arm. At interim analysis, nonintensive-arm OS hazard ratio (HR) between treatment groups was 1.191 (95% confidence interval [CI], 0.744-1.906), meeting the study's definition for futility and resulting in study termination. At final analysis, median OS was 4.4 vs 6.6 months (HR, 1.132; 95% CI, 0.783-1.637; P = .5070) in the nonintensive arm (n = 205) and 7.3 vs 11.1 months (HR, 1.434; 95% CI, 0.635-3.239; P = .3798) in the intensive arm (n = 52) between Magro/Aza and control groups, respectively. Incidences of grade ≥3 adverse events were similar across Magro/Aza and control groups (nonintensive, n = 194: 96.9% and 95.9%; intensive, n = 50: 92.6% and 95.7%), including grade ≥3 anemia (nonintensive: 27.1% and 23.5%; intensive: 25.9% and 21.7%). Grade ≥3 infections were observed in 50.0% and 53.1% of patients in the nonintensive arm and 44.4% and 65.2% of intensive-arm patients. ENHANCE-2 did not meet its primary end point of OS in TP53-mutated AML but provides important data informing future studies in this challenging population. This trial was registered at www.clinicaltrials.gov as #NCT04778397.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineLeukemia, Myeloid, AcuteMutationTumor Suppressor Protein p53AdultAgedAged, 80 and overBridged Bicyclo Compounds, HeterocyclicFemaleHumansMaleMiddle AgedSulfonamidesAntibodies, Monoclonal, HumanizedAzacitidineBridged Bicyclo Compounds, HeterocyclicSulfonamidesTP53 protein, humanTumor Suppressor Protein p53venetoclax

Identifiers

PMID40009500
PMCPMC12824667

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.