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    DRUG CLASS:

    Hypomethylating agent

    Related drugs:
    22d
    Vibecotamab for measurable residual disease in acute myeloid leukemia and for myelodysplastic syndromes and chronic myelomonocytic leukemia after hypomethylating agent failure: a phase II study. (PubMed, J Hematol Oncol)
    Vibecotamab was active in low-blast myeloid diseases, although the durability of responses was modest. Additional studies of CD123-targeting bispecific antibodies, alone or in combination, are warranted for these diseases.
    P2 data • Journal
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    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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    vibecotamab (XmAb14045)
    24d
    A Nomogram Prediction Model and Scoring System for Resistance in Acute Myeloid Leukemia Patients Treated with Venetoclax Combined with Hypomethylating Agents. (PubMed, Curr Oncol)
    KIT, TP53, and FAB-M5 are independent factors influencing VEN resistance. The constructed nomogram prediction model and scoring system may provide valuable references for predicting primary resistance to VEN.
    Retrospective data • Journal
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    TP53 (Tumor protein P53)
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    Venclexta (venetoclax)
    25d
    Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-Risk Myelodysplastic Syndrome That Has Not Responded to Other Treatment (clinicaltrials.gov)
    P1, N=18, Suspended, National Cancer Institute (NCI) | N=30 --> 18
    Enrollment change
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    CD33 (CD33 Molecule)
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    CD33 positive
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    Actimab-A (lintuzumab-Ac225)
    1m
    A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | Trial completion date: Aug 2029 --> Jun 2026 | Trial primary completion date: Aug 2027 --> Jun 2026
    Trial completion date • Trial primary completion date
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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    IDH1 mutation
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    azacitidine • Rezlidhia (olutasidenib)
    2ms
    Initial leukemic epigenomic state determines hypomethylating agent response. (PubMed, Nat Commun)
    Hypomethylation and chromatin accessibility at ZNF143- and CTCF-binding sites results in activation of HOXB4, which defines the HSC/MPP-like state and HMA-sensitivity. Our study provides evidence that the epigenomic state of the LSC is a major determinant of response to HMAs, and demonstrates that a routine clinical assay can identify patients who will respond.
    Journal
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    HOXB4 (Homeobox B4) • ZNF143 (Zinc Finger Protein 143)
    2ms
    NCI-2022-02215: A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure (clinicaltrials.gov)
    P2, N=51, Terminated, M.D. Anderson Cancer Center | Trial completion date: Dec 2026 --> May 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2026 --> May 2026; <75% participation
    Trial completion date • Trial termination • Trial primary completion date • Minimal residual disease
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    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    vibecotamab (XmAb14045)
    2ms
    Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN (clinicaltrials.gov)
    P1, N=102, Active, not recruiting, Jacqueline Garcia, MD | Trial completion date: Mar 2027 --> Mar 2030
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • NRAS (Neuroblastoma RAS viral oncogene homolog) • BCR (BCR Activator Of RhoGEF And GTPase) • BCL2 (B-cell CLL/lymphoma 2) • NPM1 (Nucleophosmin 1) • NF1 (Neurofibromin 1) • RUNX1 (RUNX Family Transcription Factor 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • KMT2A (Lysine Methyltransferase 2A) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11) • SRSF2 (Serine and arginine rich splicing factor 2) • BCOR (BCL6 Corepressor) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • STAG2 (Stromal Antigen 2) • MECOM (MDS1 And EVI1 Complex Locus) • NUP214 (Nucleoporin 214) • GATA2 (GATA Binding Protein 2) • DEK (DEK Proto-Oncogene) • RIT1 (Ras Like Without CAAX 1) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
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    TP53 mutation • KRAS mutation • NRAS mutation • RUNX1 mutation • RAS mutation • ASXL1 mutation • CBL mutation • Chr del(5q)
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    Venclexta (venetoclax) • azacitidine • Inqovi (decitabine/cedazuridine) • fludarabine IV • busulfan
    2ms
    A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=45 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    azacitidine • Rezlidhia (olutasidenib)
    2ms
    22P.205: Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=6, Completed, Thomas Jefferson University | Active, not recruiting --> Completed
    Trial completion
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • azacitidine • decitabine • navitoclax (ABT 263)
    3ms
    TAGALONG: Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents (clinicaltrials.gov)
    P2, N=53, Recruiting, Joshua Zeidner | Trial completion date: Dec 2027 --> Jul 2031 | Trial primary completion date: Aug 2027 --> Jul 2030
    Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Venclexta (venetoclax) • azacitidine • Elzonris (tagraxofusp-erzs)
    4ms
    Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=12, Recruiting, Medical College of Wisconsin | Trial completion date: Oct 2027 --> Dec 2027 | Trial primary completion date: Oct 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
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    iadademstat (ORY-1001)
    4ms
    M-HArbOr: Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia (clinicaltrials.gov)
    P1, N=18, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
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    azacitidine • Ojjaara (momelotinib)