Cited by 478Acute Myeloid Leukemia ResearchGlioma Diagnosis and TreatmentChromatin Remodeling and Cancer

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AG-221, a First-in-Class Therapy Targeting Acute Myeloid Leukemia Harboring Oncogenic IDH2 Mutations

Yen, Katharine, Travins, Jeremy, Wang, Fang, David, Muriel D., Artin, Erin, Straley, Kimberly, Padyana, Anil, Gross, Stefan, DeLaBarre, Byron, Tobin, Erica, Chen, Yue, Nagaraja, Raj, Choe, Sung, Jin, Lei, Konteatis, Zenon, Cianchetta, Giovanni, Saunders, Jeffrey O., Salituro, Francesco G., Quivoron, Cyril, Opolon, Paule, Bawa, Olivia, Saada, Véronique, Paci, Angelo, Broutin, Sophie, Bernard, Olivier A., de Botton, Stéphane, Marteyn, Benoît S., Pilichowska, Monika, Xu, YingXia, Fang, Cheng, Jiang, Fan, Wei, Wentao, Jin, Shengfang, Silverman, Lee, Liu, Wei, Yang, Hua, Dang, Lenny, Dorsch, Marion, Penard-Lacronique, Virginie, Biller, Scott A., Su, Shin-San Michael·2017·Cancer Discovery

DOI 10.1158/2159-8290.cd-16-1034

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Abstract

Somatic gain-of-function mutations in isocitrate dehydrogenases (IDH) 1 and 2 are found in multiple hematologic and solid tumors, leading to accumulation of the oncometabolite (R)-2-hydroxyglutarate (2HG). 2HG competitively inhibits α-ketoglutarate–dependent dioxygenases, including histone demethylases and methylcytosine dioxygenases of the TET family, causing epigenetic dysregulation and a block in cellular differentiation. In vitro studies have provided proof of concept for mutant IDH inhibition as a therapeutic approach. We report the discovery and characterization of AG-221, an orally available, selective, potent inhibitor of the mutant IDH2 enzyme. AG-221 suppressed 2HG production and induced cellular differentiation in primary human IDH2 mutation–positive acute myeloid leukemia (AML) cells ex vivo and in xenograft mouse models. AG-221 also provided a statistically significant survival benefit in an aggressive IDH2R140Q-mutant AML xenograft mouse model. These findings supported initiation of the ongoing clinical trials of AG-221 in patients with IDH2 mutation–positive advanced hematologic malignancies. Significance: Mutations in IDH1/2 are identified in approximately 20% of patients with AML and contribute to leukemia via a block in hematopoietic cell differentiation. We have shown that the targeted inhibitor AG-221 suppresses the mutant IDH2 enzyme in multiple preclinical models and induces differentiation of malignant blasts, supporting its clinical development. Cancer Discov; 7(5); 478–93. ©2017 AACR. See related commentary by Thomas and Majeti, p. 459. See related article by Shih et al., p. 494. This article is highlighted in the In This Issue feature, p. 443

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Authors: Yen, K., Travins, J., Wang, F., David, M. D., Artin, E., Straley, K., Padyana, A., Gross, S., DeLaBarre, B., Tobin, E., Chen, Y., Nagaraja, R., Choe, S., Jin, L., Konteatis, Z., Cianchetta, G., Saunders, J. O., Salituro, F. G., Quivoron, C., Opolon, P., Bawa, O., Saada, V., Paci, A., Broutin, S., Bernard, O. A., de Botton, S., Marteyn, B. S., Pilichowska, M., Xu, Y., Fang, C., Jiang, F., Wei, W., Jin, S., Silverman, L., Liu, W., Yang, H., Dang, L., Dorsch, M., Penard-Lacronique, V., Biller, S. A., & Su, S.-S. M.
Affiliations: Agios Pharmaceuticals (United States) (US)
Inserm (FR)
1Agios Pharmaceuticals, Inc., Cambridge, Massachusetts.
Université Paris-Saclay (FR)
6Service de Pharmacologie, Département de Biologie et Pathologie Médicales, Gustave Roussy, Université Paris-Saclay, Villejuif, France.
2INSERM U1170, Villejuif, France.
Tufts Medical Center (US)
11ShangPharma, Shanghai, China.
Viva Biotech (China) (CN)
Corresponding author: Su, Shin-San Michael
ORCID: Yen, Katharine
Wang, Fang
David, Muriel D.
Padyana, Anil
Tobin, Erica
Chen, Yue
Choe, Sung
Jin, Lei
Konteatis, Zenon
Salituro, Francesco G.
Quivoron, Cyril
Opolon, Paule
Bawa, Olivia
Saada, Véronique
Broutin, Sophie
Bernard, Olivier A.
Marteyn, Benoît S.
Pilichowska, Monika
Jiang, Fan
Wei, Wentao
Liu, Wei
Yang, Hua
Dang, Lenny
Venue: Cancer Discovery
Publisher: American Association for Cancer Research (AACR)
Published: 2017-04-30
Volume: 7
Issue: 5
Pages: 478-493
ISSN: 2159-8274 (ISSN-L)
2159-8290
DOI: 10.1158/2159-8290.cd-16-1034
OpenAlex: W2588385654
Cited by: 471
References: 52
Citations by year: 2026: 35 · 2025: 47 · 2024: 51 · 2023: 46 · 2022: 48 · 2021: 78 · 2020: 55 · 2019: 37 · 2018: 51 · 2017: 23
FWCI: 34.99
Type: journal article
Language: en
Open access: closed
Locations: Cancer Discovery (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute (INCa-DGOS-Inserm_6043 and INCa 2012-1-RT-09)
Association pour la Recherche sur le Cancer (SL220130607089)
Institut National Du Cancer (INCa-DGOS_5733)
Topics: Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
Health Sciences › Medicine › Oncology › Glioma Diagnosis and Treatment
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Chromatin Remodeling and Cancer
Keywords: IDH2 inhibitors, acute myeloid leukemia, IDH2 mutation, 2-hydroxyglutarate, oncometabolites, hematopoietic differentiation, TET methylcytosine dioxygenases, histone demethylase, xenograft mouse model
MeSH terms: Aminopyridines, Animals, Antineoplastic Agents, Humans, Isocitrate Dehydrogenase, Mutation, Triazines, Leukemia, Myeloid, Acute, Xenograft Model Antitumor Assays, Cell Line, Tumor, Mice

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AG-221, a First-in-Class Therapy Targeting Acute Myeloid Leukemia Harboring Oncogenic IDH2 Mutations

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