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

EJHaem Pub Date : 2025-05-13 DOI:10.1002/jha2.70051

Gabriel N. Mannis, Camille N. Abboud, Naval G. Daver, Guru Subramanian Guru Murthy, Eunice S. Wang, Terrence J. Bradley, George Yaghmour, Pankit Vachhani, Suresh Kumar Balasubramanian, Chong Chyn Chua, Chun Yew Fong, Adam S. Asch, Mei Dong, Shuang Li, Taravat Bagheri, Parul Doshi, Paresh Vyas, Monzr M. Al Malki

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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.

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美洛单抗联合治疗急性髓性白血病的2期多组研究

这项2期研究评估了马格罗单抗+venetoclax (VEN)+阿扎胞苷（AZA）治疗未治疗的急性髓性白血病（AML）和马格罗单抗+米托蒽醌+依托泊苷+阿糖胞苷治疗复发/难治性AML （R/R）的疗效。方法终点包括完全缓解率（CRR）、总缓解率（ORR）、总生存期（OS）和安全性。结果18例和36例患者分别被纳入不适合和R/R AML组。不适应AML组和R/R AML组的CRR分别为38.9%和25.0%，ORR分别为66.7%和38.9%，中位OS分别为15.3和10.5个月。未发生剂量限制性毒性或马格罗莫单抗相关死亡。结论美格罗单抗与现有AML治疗药物联用是安全的，无新的安全性信号。该试验在www.clinicaltrials.gov注册，编号为NCT04778410。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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EJHaem

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