Evidence map›Paper›PMID 34933333›Full record

Trial reportBlood advances2022

A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML.

Amer M Zeidan, Isaac Boss, C L Beach, Wilbert B Copeland, Ethan Thompson, Brian A Fox, Vanessa E Hasle, Andrzej Hellmann, David C Taussig, Mar Tormo and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02775903 (A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab), which is not on this map. Cited by 59 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 4 pooled it
8.9field-weighted citation impact, top 2% of its field
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.

NCT02775903 phase2completednot on this map

A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)

TypeinterventionalSponsorCelgeneRan2016 to 2021Enrolled213ConditionsLeukemia, Myeloid, Acute, Myelodysplastic SyndromesArmsAzacitidine, Durvalumab
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 4 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
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  14. Article
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  17. Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026
    Review
  18. Molecular and Clinical Insights intoInternational journal of molecular sciences · 2025
    Review
  19. Review
  20. Review
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

16 authors at 8 institutions in 5 countries.

Amer M ZeidanYale University and Yale Cancer Center, New Haven, CT.
Isaac BossBristol Myers Squibb, Princeton, NJ.
C L BeachBristol Myers Squibb, Princeton, NJ.
Wilbert B CopelandBristol Myers Squibb, Princeton, NJ.
Ethan ThompsonBristol Myers Squibb, Princeton, NJ.
Brian A FoxBristol Myers Squibb, Princeton, NJ.ORCID 0000-0001-6620-3853
Vanessa E HasleBristol Myers Squibb, Princeton, NJ.
Andrzej HellmannUniversity Clinical Center of Medical University of Gdańsk, Gdańsk, Poland.
David C TaussigThe Royal Marsden NHS Foundation Trust, Sutton, United Kingdom.
Mar TormoHospital Clinico Universitario de Valencia and INCLIVA Biomedical Research Institute, Valencia, Spain.
Maria Teresa VosoAF Oncoematologia-Universita' di Roma Tor Vergata, Rome, Italy.ORCID 0000-0002-6164-4761
James CavenaghBarts Health NHS Trust, St. Bartholomew's Hospital, West Smithfield, London, United Kingdom; and.
Tim O'ConnorBristol Myers Squibb, Princeton, NJ.
Alessandro PrevitaliBristol Myers Squibb, Princeton, NJ.
Shelonitda RoseBristol Myers Squibb, Princeton, NJ.
Lewis R SilvermanIcahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY.
Bristol-Myers Squibb (United States) · USGdańsk Medical University · PLHospital Clínico Universitario de Valencia · ESRoyal Marsden NHS Foundation Trust · GBSt Bartholomew's Hospital · GBTisch Cancer InstituteUniversity of Rome Tor Vergata · ITYale Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Evidence suggests that combining immunotherapy with hypomethylating agents may enhance antitumor activity. This phase 2 study investigated the activity and safety of durvalumab, a programmed death-ligand 1 (PD-L1) inhibitor, combined with azacitidine for patients aged ≥65 years with acute myeloid leukemia (AML), including analyses to identify biomarkers of treatment response. Patients were randomized to first-line therapy with azacitidine 75 mg/m2 on days 1 through 7 with (Arm A, n = 64) or without (Arm B, n = 65) durvalumab 1500 mg on day 1 every 4 weeks. Overall response rate (complete response [CR] + CR with incomplete blood recovery) was similar in both arms (Arm A, 31.3%; Arm B, 35.4%), as were overall survival (Arm A, 13.0 months; Arm B, 14.4 months) and duration of response (Arm A, 24.6 weeks; Arm B, 51.7 weeks; P = .0765). No new safety signals emerged with combination treatment. The most frequently reported treatment-emergent adverse events were constipation (Arm A, 57.8%; Arm B, 53.2%) and thrombocytopenia (Arm A, 42.2%; Arm B, 45.2%). DNA methylation, mutational status, and PD-L1 expression were not associated with response to treatment. In this study, first-line combination therapy with durvalumab and azacitidine in older patients with AML was feasible but did not improve clinical efficacy compared with azacitidine alone. ClinicalTrials.gov: NCT02775903.

Indexed as

AzacitidineLeukemia, Myeloid, AcuteAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsHumansAntibodies, MonoclonalAzacitidinedurvalumab

Identifiers

PMID34933333
PMCPMC9006260
OpenAlexW4200082342

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.