MDM2 inhibitor APG-115 exerts potent antitumor activity and synergizes with standard-of-care agents in preclinical acute myeloid leukemia models
Open accessAbstract
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.
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APG-115 is the first MDM2-p53 inhibitor to undergo clinical trials in China, thus filling a crucial gap in the field of drug development for this target in the country.
“APG-115 is the first MDM2-p53 inhibitor to undergo clinical trials in China, thus filling a crucial gap in the field of drug development for this target in the country.403”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [403]
APG-115 is an MDM2 inhibitor that activates p53 through the MDM2-p53 interaction.
“APG-115 is an MDM2 inhibitor could activate p53 through MDM2-p53 interaction”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [403]
APG-115 combined with pembrolizumab showed good tolerability and preliminary indications of antitumor activity in a clinical trial for patients with metastatic melanoma and advanced-stage solid tumors.
“its combination with pembrolizumab has been shown good tolerability and preliminary indications of antitumor activity in a clinical trial for patients with metastatic melanoma and advanced-stage solid tumors (NCT03611868).403,405”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [403]
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Cell death pathways and targeting therapeutics in cancer therapy
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Spirooxindole derivatives as an anticancer agent
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- Authors
- Fang, D. D., Tang, Q., Kong, Y., Rong, T., Wang, Q., Li, N., Fang, X., Gu, J., Xiong, D., Yin, Y., Deng, J., Yang, D., & Zhai, Y.
- Affiliations
- Sun Yat-sen University Cancer Center (CN)
- Ascentage Pharma Group Inc. (United States) (US)
- Corresponding author
- Yang, Dajun
- Zhai, Yifan
- ORCID
- Venue
- Cell Death Discovery
- Published
- 2021-05-03
- Volume
- 7
- Issue
- 1
- Pages
- 90-90
- ISSN
- 2058-7716 (ISSN-L)
- PMC
- PMC8093284
- OpenAlex
- W3159617635
- Cited by
- 58
- References
- 46
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 17 · 2023: 9 · 2022: 13 · 2021: 2
- FWCI
- 3.91
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Cell Death Discovery (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Ascentage Pharma
- National Science and Technology Major Project
- Topics
- Health Sciences › Medicine › Oncology › Cancer-related Molecular Pathways
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Tyrosine Phosphatases
- Keywords
- MDM2 inhibitors, acute myeloid leukemia, p53/p21 pathway, azacitidine, decitabine, cytarabine, combination therapy, synergistic antitumor effect, apoptosis, cell cycle arrest, DNA damage
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