Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 May 13;6(3):e70051.
doi: 10.1002/jha2.70051. eCollection 2025 Jun.

Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Acute Myeloid Leukaemia

Gabriel N Mannis  1 , Camille N Abboud  2 , Naval G Daver  3 , Guru Subramanian Guru Murthy  4 , Eunice S Wang  5 , Terrence J Bradley  6 , George Yaghmour  7 , Pankit Vachhani  8 , Suresh Kumar Balasubramanian  9 , Chong Chyn Chua  10 , Chun Yew Fong  11 , Adam S Asch  12 , Mei Dong  13 , Shuang Li  13 , Taravat Bagheri  13 , Parul Doshi  13 , Paresh Vyas  14 , Monzr M Al Malki  15
Affiliations

Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Acute Myeloid Leukaemia

Gabriel N Mannis et al. EJHaem. .

Abstract

Introduction: This phase 2 study evaluated magrolimab+venetoclax (VEN)+azacitidine (AZA) in untreated, unfit acute myeloid leukaemia (AML) and magrolimab+mitoxantrone+etoposide+cytarabine in relapsed/refractory (R/R) AML.

Methods: Endpoints included complete remission rate (CRR), overall response rate (ORR), overall survival (OS) and safety.

Results: Eighteen and 36 patients were enrolled into the unfit and R/R AML arms, respectively. CRR was 38.9% and 25.0%, ORR was 66.7% and 38.9%, and median OS was 15.3 and 10.5 months in the unfit AML and R/R AML arms, respectively. No dose-limiting toxicities or magrolimab-related deaths occurred.

Conclusion: Magrolimab was safely combined with existing AML therapies with no new safety signals.

Clinical trial registration: This trail was registered at www.clinicaltrials.gov as NCT04778410.

Keywords: AML | chemotherapy | clinical research | haematological malignancy | haematological oncology | immunotherapy.

PubMed Disclaimer

Conflict of interest statement

Gabriel N. Mannis reports institutional research funding from Jazz, Astex, Glycomimetics, Syndax, ImmuneOnc, Forty‐Seven, Aptose and BMS/Celgene; consulting or advisory roles for Abbvie, Agios, Pfizer, Servier and Stemline; participation on a data safety monitoring board or advisory board for Abbvie, Agios, Astellas, BMS/Celgene, Genentech Stemline, Rigel, Wugen and Immunogen. Naval G. Daver reports grants or contracts from Daiichi‐Sankyo, Bristol‐Meyers Squibb, Pfizer, Gilead Sciences, Inc., Servier, Genentech, Astellas, AbbVie, ImmunoGen, Amgen, Trillium, Hanmi, Trovagene, FATE Therapeutics, Novimmune, Glycomimetics and Kite; consulting or advisory roles for Daichii‐Sankyo, Bristol‐Meyers Squibb, Pfizer, Gilead Sciences, Inc., Servier, Genentech, Astellas, AbbVie, ImmunoGen, Amgen, Trillium, Arog, Novartis, Jazz, Celgene, Syndax, Shattuck Labs, Agios, Kite and Stemline/Menarini. Guru Subramanian Guru Murthy reports institutional research funding from Xencor Inc., Zentalis Inc., Beigene, Lilly/LOXO, Oryzon Genomics, Merck and Schrodinger; consulting or advisory roles for Amgen Inc., BeiGene, Gilead/Kite, Pfizer, BMS, Rigel, Stemline Therapeutics, Cardinal Health, Servier, DAVA Oncology, Aptitude Health, Curio Science and Autolus Therapeutics; payment/honoraria for lecturing, presentations, serving on speaker bureaus, writing manuscripts or educational events from Rigel, Stemline Therapeutics, Cardinal Health, DAVA Oncology, Aptitude Health, Curio Science and Amgen. Eunice S. Wang reports consulting or advisory roles for AbbVie, Blueprint, Daiichi Sankyo, Immunogen, Kite, Kura, Novartis, Qiagen, Rigel, Ryvu, Schrodinger, Servier, Stemline, Syndax and Takeda; speaker bureau participation for Astellas, Dava and Pfizer; serving on data safety and monitoring committees for AbbVie and Gilead Sciences, Inc; and serving as Section Editor for UpToDate (Wolters Kluwer). Terrence J. Bradley reports consulting or advisory roles for Novartis and Morphosys; participation on a data safety monitoring board or advisory board for KaryoPharm, Morphosys, Servier and Sobi. George Yaghmour reports receiving payment/honoraria for lecturing, presentations, serving on speaker bureaus, writing manuscripts or educational events from Jazz, Incyte, Astellas, BMS, Secura bio, blueprint, Sobi, Karius, Kite, Celgene, AbbVie, Rigel, Servier, GSK, Takeda and Pfizer; participation on a data safety monitoring board or advisory board for Gilead Sciences, Inc., Alexion, Pfizer, AbbVie and Servier. Pankit Vachhani reports consulting or advisory roles for Abbvie, Amgen, Blueprint Medicines, Cogent Biosciences, Incyte, CTI BioPharma Corp (now Sobi), Daiichi Sankyo, GlaxoSmith Kline, Karyopharm, Novartis, Pfizer, Genentech, Servier, Stemline, MorphoSys and LAVA therapeutics; receiving payment/honoraria for lecturing, presentations, serving on speaker bureaus, writing manuscripts or educational events from Incyte, CTI biopharma (now Sobi) and Blueprint Medicines. Suresh Kumar Balasubramanian reports receiving research support from Kura Oncology. Chong Chyn Chua reports receiving payment/honoraria for lecturing, presentations, serving on speaker bureaus, writing manuscripts or educational events from Astra Zeneca, Bristol‐Myers Squibb, AbbVie and Ostuka; and participation on advisory boards for AbbVie, Pfizer, Sumitomo Pharma. Chun Yew Fong reports consulting or advisory roles for AbbVie, Novotech, Adaptive, Amgen, Servier, Pfizer, Otsuka, Celgene, Jazz and Astellas; receiving payment/honoraria for lecturing, presentations, serving on speaker bureaus, writing manuscripts or educational events from AbbVie, Amgen and Pfizer; support for attending meetings and/or travel from Gilead Sciences, Inc. and Kite. Mei Dong, Shuang Li, Taravat Bagheri and Parul Doshi are employees of Gilead Sciences, Inc. Shuang Li holds stock or stock options for Gilead Sciences, Inc., Novartis and Sandoz. Mei Dong and Parul Doshi hold stock or stock options for Gilead Sciences, Inc. Paresh Vyas reports advisory roles or travel/accommodation from AbbVie, Auron Therapeutics, ImmunoGen, Jazz Pharmaceuticals, Kura, Pfizer, Rigel, Servier, Stemline Menarini, and Takeda; honoraria from AbbVie, Astellas, Celgene, Daiichi Sankyo, Jazz Pharmaceuticals, and Pfizer; speaker's bureaus with AbbVie, Astellas, Gilead, and Servier; research funding to his institution from Bristol Myers Squibb/Celgene; stock or ownership in Auron Therapeutics and Yellowstone Biosciences; patents for flow cytometric detection of leukemic stem cell. Monzr M. Al Malki reports receiving research support from Gilead Sciences, Inc. and Incyte; and consulting for NexImmune, Inc., TScan Therapeutics, CareDx and Tr1X, Inc. Camille N. Abboud and Adam S. Asch have nothing to declare.

References

    1. Winer E. S. and Stone R. M., “Novel Therapy in Acute Myeloid Leukemia (AML): Moving Toward Targeted Approaches,” Therapeutic Advances in Hematology 10 (2019): 2040620719860645. - PMC - PubMed
    1. DiNardo C. D., Jonas B. A., Pullarkat V., et al., “Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia,” New England Journal of Medicine 383, no. 7 (2020): 617–629. - PubMed
    1. Pratz K. W., Jonas B. A., Pullarkat V., et al., “Long‐term Follow‐up of VIALE‐A: Venetoclax and Azacitidine in Chemotherapy‐ineligible Untreated Acute Myeloid Leukemia,” American Journal of Hematology 99, no. 4 (2024): 615–624. - PubMed
    1. Feldman E. J., Brandwein J., Stone R., et al., “Phase III Randomized Multicenter Study of a Humanized Anti‐CD33 Monoclonal Antibody, lintuzumab, in Combination With Chemotherapy, versus Chemotherapy Alone in Patients With Refractory or First‐relapsed Acute Myeloid Leukemia,” Journal of Clinical Oncology 23, no. 18 (2005): 4110–4116. - PubMed
    1. Lee S.‐S., Lee J.‐H., Lee J.‐H., et al., “Single‐dose Mitoxantrone in Combination With Continuous Infusion Intermediate‐dose Cytarabine plus Etoposide for Treatment of Refractory or Early Relapsed Acute Myeloid Leukemia,” Leukemia Research 33, no. 4 (2009): 511–517. - PubMed

Associated data

LinkOut - more resources