Magrolimab in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes: Final Results of a Phase Ib Study
Open accessAbstract
PURPOSE: Magrolimab is a monoclonal antibody that blocks cluster of differentiation 47, a don't-eat-me signal overexpressed on cancer cells. Cluster of differentiation 47 blockade by magrolimab promotes macrophage-mediated phagocytosis of tumor cells and is synergistic with azacitidine, which increases expression of eat-me signals. We report final phase Ib data in patients with untreated higher-risk myelodysplastic syndromes (MDS) treated with magrolimab and azacitidine (ClinicalTrials.gov identifier: NCT03248479 ). PATIENTS AND METHODS: Patients with previously untreated Revised International Prognostic Scoring System intermediate-/high-/very high-risk MDS received magrolimab intravenously as a priming dose (1 mg/kg) followed by ramp-up to a 30 mg/kg once‐weekly or once‐every-2-week maintenance dose. Azacitidine 75 mg/m 2 was administered intravenously/subcutaneously once daily on days 1-7 of each 28-day cycle. Primary end points were safety/tolerability and complete remission (CR) rate. RESULTS: Ninety-five patients were treated. Revised International Prognostic Scoring System risk was intermediate/high/very high in 27%, 52%, and 21%, respectively. Fifty-nine (62%) had poor-risk cytogenetics and 25 (26%) had TP53 mutation. The most common treatment-emergent adverse effects included constipation (68%), thrombocytopenia (55%), and anemia (52%). Median hemoglobin change from baseline to first postdose assessment was −0.7 g/dL (range, −3.1 to +2.4). CR rate and overall response rate were 33% and 75%, respectively. Median time to response, duration of CR, duration of overall response, and progression-free survival were 1.9, 11.1, 9.8, and 11.6 months, respectively. Median overall survival (OS) was not reached with 17.1-month follow-up. In TP53-mutant patients, 40% achieved CR with median OS of 16.3 months. Thirty-four patients (36%) had allogeneic stem-cell transplant with 77% 2-year OS. CONCLUSION: Magrolimab + azacitidine was well tolerated with promising efficacy in patients with untreated higher-risk MDS, including those with TP53 mutations. A phase III trial of magrolimab/placebo + azacitidine is ongoing (ClinicalTrials.gov identifier: NCT04313881 [ENHANCE]).
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MRD is a good surrogate marker for OS in a prospective frontline HR-MDS study.
“MRD is a good surrogate marker for OS as recently shown in a prospective frontline HR‐MDS study.”
From Long‐term follow‐up and combined Phase 2 results of eprenetapopt and azacitidine in patients with <i>TP53</i> mutant MDS/AML (2025) · cites this paper as [39]
The Results (Efficacy; page not available) report that survival curves favored MRD-negative patients in this study of untreated higher-risk MDS. However, median OS was not reached in either MRD group, and the paper does not establish MRD as a good surrogate marker for OS; that characterization is stronger than its finding. (LLM, conf=0.86)
Experimental — accuracy not yet measuredEarly results of AZA and magrolimab showed high response rates (CR 33%, ORR 75%) with outcomes favorable to historical outcomes in HR-MDS.
“Recently, early results of an initial study of AZA and magrolimab had shown high response rates (CR 33%, ORR 75%) with outcomes favorable to historical outcomes in HR‐MDS.”
From Long‐term follow‐up and combined Phase 2 results of eprenetapopt and azacitidine in patients with <i>TP53</i> mutant MDS/AML (2025) · cites this paper as [39]
Phase 3 ENHANCE and ENHANCE-2 studies were closed for futility with lower OS in combination cohorts.
“However, Phase 3 ENHANCE (HR‐MDS) and ENHANCE‐2 studies (mTP53 AML) were closed for futility with lower OS observed in the combination cohorts.”
From Long‐term follow‐up and combined Phase 2 results of eprenetapopt and azacitidine in patients with <i>TP53</i> mutant MDS/AML (2025) · cites this paper as [40]
The Discussion (page unavailable) says the phase 3 ENHANCE trial was recruiting as of this report. Searches for ENHANCE-2, futility, and lower overall survival found no passage reporting that either trial closed or comparing survival between its treatment cohorts. Recruiting at the time of this report does not rule out a later closure. (LLM, conf=0.76)
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Sallman, D. A., Komrokji, R. S., Dezern, A. E., Sebert, M., Garcia‐Manero, G., Rahmé, R., Winer, E. S., Lehmann‐Che, J., Roboz, G. J., Madelaine, I., et al. (2025) · HemaSphere · doi:10.1002/hem3.70164 · Cited by 20 · see citing works
“39,46 In our study, a potentially curative approach was possible for m TP53 patients obtaining a response with NGS negativity followed by allo ‐ HCT.”
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- Authors
- Sallman, D. A., Al Malki, M. M., Asch, A. S., Wang, E. S., Jurcic, J. G., Bradley, T. J., Flinn, I. W., Pollyea, D. A., Kambhampati, S., Tanaka, T. N., Zeidner, J. F., Garcia-Manero, G., Jeyakumar, D., Komrokji, R., Lancet, J., Kantarjian, H. M., Gu, L., Zhang, Y., Tan, A., Chao, M., O'Hear, C., Ramsingh, G., Lal, I., Vyas, P., & Daver, N. G.
- Affiliations
- Moffitt Cancer Center (US)
- City of Hope National Medical Center, Duarte, CA
- OU Health Stephenson Cancer Center (US)
- Roswell Park Comprehensive Cancer Center (US)
- Columbia University Irving Medical Center (US)
- University of Miami (US)
- Tennessee Oncology (US)
- University of Colorado Anschutz (US)
- Sarah Cannon Cancer Institute, Kansas City, MO
- Moores Cancer Center (US)
- University of North Carolina at Chapel Hill (US)
- The University of Texas MD Anderson Cancer Center, Houston, TX
- University of California, Irvine (US)
- The University of Texas MD Anderson Cancer Center (US)
- Gilead Sciences (United States) (US)
- University of Oxford (GB)
- Corresponding author
- Sallman, David A.
- ORCID
- Sallman, David A.
- Al Malki, Monzr M.
- Wang, Eunice S.
- Jurcic, Joseph G.
- Flinn, Ian W.
- Pollyea, Daniel A.
- Kambhampati, Suman
- Tanaka, Tiffany N.
- Zeidner, Joshua F.
- Garcia-Manero, Guillermo
- Jeyakumar, Deepa
- Komrokji, Rami
- Lancet, Jeffrey
- Kantarjian, Hagop M.
- Gu, Lin
- Chao, Mark
- Ramsingh, Giridharan
- Vyas, Paresh
- Daver, Naval G.
- Venue
- Journal of Clinical Oncology
- Published
- 2023-05-20
- Volume
- 41
- Issue
- 15
- Pages
- 2815-2826
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC10414740
- OpenAlex
- W4323539126
- Cited by
- 188
- References
- 48
- Citations by year
- 2026: 50 · 2025: 64 · 2024: 44 · 2023: 27 · 2022: 1
- FWCI
- 38.21
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Journal of Clinical Oncology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Digital Commons-TMC (Texas Medical Center) (submittedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Gilead Sciences
- Teva Pharmaceutical Industries
- Celgene
- Karyopharm Therapeutics
- Taiho Pharmaceutical
- Jazz Pharmaceuticals
- TG Therapeutics
- PTC Therapeutics
- Astex Pharmaceuticals
- Acceleron
- MEI Pharma
- Foghorn Therapeutics
- Agios Pharmaceuticals
- CareDx
- Constellation Pharmaceuticals
- bluebird bio
- Unum Therapeutics
- BeiGene
- CTI Biopharma
- Incyte
- Syndax Pharmaceuticals
- Ascentage Pharma
- National Institute for Health and Care Research (NF-SI-0617-10056)
- Kiadis Pharma
- Astellas Pharma
- Servier
- MorphoSys
- Ipsen
- Sumitomo Dainippon Pharma Oncology
- Genentech
- Pharmacyclics
- Juno Therapeutics
- Medical Research Council (MC_PC_19049, MC_UU_00029/8, MC_UU_00016/11, MR/L008963/1)
- National Cancer Institute (UM1CA186712)
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Life Sciences › Immunology and Microbiology › Immunology › Phagocytosis and Immune Regulation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
- Keywords
- ab, azacitidine, myelodysplastic syndrome, CD47 blockade, macrophage phagocytosis, complete remission, TP53 mutation, allogeneic stem cell transplantation, progression-free survival, safety and tolerability, combination immunotherapy, poor-risk cytogenetics
- MeSH terms
- Progression-Free Survival, Azacitidine, Humans, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Treatment Outcome, Antibodies, Monoclonal, Humanized
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