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    DRUG:

    Tibsovo (ivosidenib)

    i
    Other names: AG-120, AG 120, AG120, CS3010, S95031, CS-3010, CS 3010, S-95031, S 95031
    Company:
    CStone Pharma, Sagard Healthcare, Schrodinger, Servier
    Drug class:
    IDH1 inhibitor
    Related drugs:
    3d
    AG120-C-001: Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation (clinicaltrials.gov)
    P1, N=291, Recruiting, Institut de Recherches Internationales Servier | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)
    6d
    CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    20d
    Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=2, Terminated, Northwestern University | Active, not recruiting --> Terminated; Low accrual
    Trial termination
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH1 R132
    |
    cytarabine • Tibsovo (ivosidenib) • idarubicin hydrochloride • fludarabine IV • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate)
    21d
    Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=3, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> May 2027
    Trial completion date
    |
    Tibsovo (ivosidenib)
    23d
    Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS (clinicaltrials.gov)
    P2, N=20, Recruiting, Ruijin Hospital
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    Tibsovo (ivosidenib)
    24d
    Subclonal IDH1/2 Mutations as a Targetable Vulnerability in Vascular Tumors. (PubMed, bioRxiv)
    We identify recurrent, low-VAF IDH1/2 mutations in angiosarcoma and provide evidence that these subclonal mutations promote tumorigenesis through non-cell-autonomous mechanisms. Vascular tumors driven by subclonal IDH1 mutations responded dramatically to ivosidenib, thus revealing a novel treatment for a subset of vascular tumors.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation
    |
    Tibsovo (ivosidenib)
    28d
    IDH1 R132 mutations or HER2-positivity and benefit from platinum-based therapy for biliary tract cancers. (PubMed, JHEP Rep)
    These preliminary data might indicate that targeted therapies should be introduced in first line with different strategies depending on molecular alterations, with access to platinum-based palliative systemic anti-cancer treatment being important for patients with IDH1-mutated BTC.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • IDH1 mutation • IDH1 R132 • HER-2 positive + HER-2 overexpression
    |
    Tibsovo (ivosidenib)
    1m
    Research on Targeted Therapy for Malignant Tumors of the Biliary Tract. (PubMed, Onco Targets Ther)
    Genomic profiling reveals targetable alterations-IDH1/2 mutations, FGFR2 fusions, HER2 aberrations, BRAF V600E-driving the clinical success of specific inhibitors (ivosidenib, FGFR inhibitors, HER2-targeted ADCs/antibodies, dabrafenib/trametinib). However, overcoming tumor heterogeneity, resistance mechanisms, and optimizing combination strategies remain critical challenges. This paradigm shift towards molecularly guided therapies offers significant hope for improving BTC patient survival.
    Review • Journal • MSi-H Biomarker • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600 • HER-2 mutation • FGFR2 mutation • FGFR2 fusion • IDH mutation + BRAF V600E
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • Tibsovo (ivosidenib)
    1m
    Long-term (74-month) efficacy and safety of ivosidenib and azacitidine in an elderly patient with mutated IDH1 acute myeloid leukemia: insights from a case report. (PubMed, Postgrad Med)
    The exceptional 74-month long response of this patient demonstrates that a long-term response is possible for a patient unfit for IC with mIDH1 AML treated with ivosidenib and azacitidine. Further insights into the impact of the mutational status of patients and/or the clonal hierarchy are warranted.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • DNMT3A (DNA methyltransferase 1) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1)
    |
    IDH1 mutation • RUNX1 mutation
    |
    azacitidine • Tibsovo (ivosidenib)
    1m
    DIM-95031-006: An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. (clinicaltrials.gov)
    P3, N=245, Recruiting, Servier Affaires Médicales | Trial completion date: Dec 2026 --> Oct 2027 | Trial primary completion date: Jan 2026 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)
    2ms
    DIM-95031-006: An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. (clinicaltrials.gov)
    P3, N=245, Recruiting, Servier Affaires Médicales | N=179 --> 245
    Enrollment change
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)
    2ms
    Study of SA+X in the Treatment of Newly Diagnosed AML (clinicaltrials.gov)
    P2, N=205, Recruiting, Ruijin Hospital
    New P2 trial
    |
    Xospata (gilteritinib) • azacitidine • Tibsovo (ivosidenib) • Beqalzi (sonrotoclax)