Fang Douglas D, Tang Qiuqiong, Kong Yanhui, Rong Tao, Wang Qixin, Li Na, Fang Xu, Gu Jiaxing, Xiong Dengkun, Yin Yan, Deng Jing, Yang Dajun, Zhai Yifan
Ascentage Pharma (Suzhou) Co., Ltd., 218 Xinghu Street, Suzhou, Jiangsu Province, China.
Department of Experimental Research, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Cell Death Discov. 2021 May 3;7(1):90. doi: 10.1038/s41420-021-00465-5.
Acute myeloid leukemia (AML) is a clinically and genetically heterogeneous clonal disease associated with unmet medical needs. Paralleling the pathology of other cancers, AML tumorigenesis and propagation can be ascribed to dysregulated cellular processes, including apoptosis. This function and others are regulated by tumor suppressor P53, which plays a pivotal role in leukemogenesis. Opposing P53-mediated activities is the mouse double minute 2 homolog (MDM2), which promotes P53 degradation. Because the TP53 mutation rate is low, and MDM2 frequently overexpressed, in patients with leukemia, targeting the MDM2-P53 axis to restore P53 function has emerged as an attractive AML treatment strategy. APG-115 is a potent MDM2 inhibitor under clinical development for patients with solid tumors. In cellular cultures and animal models of AML, we demonstrate that APG-115 exerted substantial antileukemic activity, as either a single agent or when combined with standard-of-care (SOC) hypomethylating agents azacitidine (AZA) and decitabine (DAC), or the DNA-damaging agent cytarabine (Ara-C). By activating the P53/P21 pathway, APG-115 exhibited potent antiproliferative and apoptogenic activities, and induced cell cycle arrest, in TP53 wild-type AML lines. In vivo, APG-115 significantly reduced tumor burden and prolonged survival. Combinations of APG-115 with SOC treatments elicited synergistic antileukemic activity. To explain these effects, we propose that APG-115 and SOC agents augment AML cell killing by complementarily activating the P53/P21 pathway and upregulating DNA damage. These findings and the emerging mechanism of action afford a sound scientific rationale to evaluate APG-115 (with or without SOC therapies) in patients with AML.
急性髓系白血病(AML)是一种临床和基因异质性的克隆性疾病,存在未满足的医疗需求。与其他癌症的病理情况相似,AML的肿瘤发生和增殖可归因于包括细胞凋亡在内的细胞过程失调。该功能及其他功能受肿瘤抑制因子P53调控,P53在白血病发生中起关键作用。与P53介导的活性相反的是小鼠双微体2同源物(MDM2),它促进P53降解。由于白血病患者中TP53突变率较低,而MDM2经常过度表达,因此靶向MDM2-P53轴以恢复P53功能已成为一种有吸引力的AML治疗策略。APG-115是一种正在针对实体瘤患者进行临床开发的强效MDM2抑制剂。在AML的细胞培养和动物模型中,我们证明APG-115作为单一药物或与标准护理(SOC)低甲基化剂阿扎胞苷(AZA)和地西他滨(DAC)或DNA损伤剂阿糖胞苷(Ara-C)联合使用时,均具有显著的抗白血病活性。通过激活P53/P21途径,APG-115在TP53野生型AML细胞系中表现出强大的抗增殖和促凋亡活性,并诱导细胞周期停滞。在体内,APG-115显著降低肿瘤负荷并延长生存期。APG-115与SOC治疗的联合使用引发了协同抗白血病活性。为了解释这些作用,我们提出APG-115和SOC药物通过互补激活P53/P21途径和上调DNA损伤来增强AML细胞杀伤作用。这些发现和新出现的作用机制为评估APG-115(无论是否联合SOC治疗)在AML患者中的应用提供了合理的科学依据。