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    DRUG CLASS:

    IDH2 inhibitor

    Related drugs:
    7d
    Isocitrate Dehydrogenase-Mutant Astrocytomas: Risk Stratification and Therapeutic Advance. (PubMed, MedComm (2020))
    Therapeutic advances are highlighted, with particular emphasis on brain-penetrant IDH inhibition (vorasidenib) and on emerging strategies including vaccines, checkpoint combinations, epigenetic modulation, metabolic and microenvironment targeting, and novel delivery platforms...Finally, future directions in trial design, survivorship-oriented endpoints, and biomarker-driven monitoring are outlined. A trajectory-based paradigm is emphasized in which neurocognitive preservation, time to radiotherapy or chemotherapy, and patient-reported outcomes are prioritized while durable disease control is pursued across decades-long survivorship.
    Review • Journal
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    TP53 (Tumor protein P53) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • ATRX (ATRX Chromatin Remodeler)
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    CDKN2A deletion
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    Voranigo (vorasidenib)
    9d
    Multidisciplinary consensus recommendations for the management of IDH-mutant grade 2 gliomas in Spain: a Delphi study. (PubMed, Clin Transl Oncol)
    This work delivers multidisciplinary consensus recommendations to standardize care in IDH-mutant grade 2 gliomas, integrating advances in molecular diagnostics, imaging, and therapeutics. It also identifies key knowledge gaps and clinical uncertainties, underscoring the critical need for ongoing research and expert collaboration to continually refine personalized management approaches and improve patient outcomes.
    Journal
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    Voranigo (vorasidenib)
    13d
    A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1, N=18, Recruiting, Memorial Sloan Kettering Cancer Center | N=36 --> 18
    Enrollment change
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    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH1 mutation • IDH2 mutation • FLT3 mutation
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    Xospata (gilteritinib) • Tibsovo (ivosidenib) • Idhifa (enasidenib)
    27d
    Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation (clinicaltrials.gov)
    P2, N=35, Recruiting, City of Hope Medical Center | Suspended --> Recruiting
    Enrollment open
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    IDH2 mutation
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    Idhifa (enasidenib)
    27d
    VANGUARD: Vorasidenib Guided by AGX PET in Recurrent/Low-grade Glioma (clinicaltrials.gov)
    P=N/A, N=10, Not yet recruiting, Huashan Hospital
    New trial
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    Voranigo (vorasidenib)
    28d
    CL1-95032-005: Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Institut de Recherches Internationales Servier | Recruiting --> Active, not recruiting
    Enrollment closed
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • ATRX (ATRX Chromatin Remodeler)
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    IDH1 R132
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    Keytruda (pembrolizumab) • Voranigo (vorasidenib)
    1m
    Preserved IDH mutation and methylation class in vorasidenib nonresponders: A report of 2 cases. (PubMed, Neurooncol Pract)
    At the last follow-up, 3 years after vorasidenib discontinuation, the disease remained stable in 1 patient, while the other one had recurred. Vorasidenib does not appear to select an IDH-wildtype clone that would potentially reduce the tumor's sensitivity to standard therapies typically used in IDH-mutated glioma.
    Journal
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    MGMT (6-O-methylguanine-DNA methyltransferase)
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    IDH wild-type
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    Voranigo (vorasidenib)
    1m
    Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation (clinicaltrials.gov)
    P2, N=35, Suspended, City of Hope Medical Center | Recruiting --> Suspended
    Trial suspension
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    IDH2 mutation
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    Idhifa (enasidenib)
    1m
    A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1, N=36, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
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    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation • IDH2 mutation • FLT3 mutation
    |
    Xospata (gilteritinib) • Tibsovo (ivosidenib) • Idhifa (enasidenib)
    1m
    Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=93, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH2 mutation
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    Venclexta (venetoclax) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)
    2ms
    AG-221-AML-005: A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy (clinicaltrials.gov)
    P1/2, N=130, Active, not recruiting, Celgene | Trial completion date: Sep 2025 --> Sep 2026
    Trial completion date
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    Tibsovo (ivosidenib) • Idhifa (enasidenib)
    2ms
    EORTC-2427-BTG: ??Vorasidenib for the treatment of IDH-mutant astrocytoma after standard chemoradiotherapy (2024-519404-27-00)
    P2/3, N=247, Recruiting, Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
    New P2/3 trial
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Voranigo (vorasidenib)