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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:
    2d
    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
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)
    10d
    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)
    17d
    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) • sonrotoclax (BGB-11417)
    17d
    AG-120 in People With IDH1 Mutant Chondrosarcoma (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    Tibsovo (ivosidenib)
    20d
    Real-World Outcomes of Ivosidenib in IDH1-Mutant Biliary Tract Cancer: A Multicenter Retrospective Analysis and Comparison with the TrinetX Database. (PubMed, Target Oncol)
    Real-world data from our cohort and the TriNetX database support the oncological outcomes reported in the ClarIDHy trial and other real-world cohorts.
    Retrospective data • Journal • Real-world evidence
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • IDH1 R132
    |
    Tibsovo (ivosidenib)
    22d
    Ivosidenib and Vorasidenib decrease intratumoral 2-hydroxyglutarate and total choline levels in patients with lower-grade glioma: an in vivo MR Spectroscopy study. (PubMed, Clin Cancer Res)
    The striking reductions in tumor 2HG and tCho levels early following initiation of targeted therapy using an IDH inhibitor suggest that MRS may provide an important tool for monitoring treatment response of lower-grade gliomas.
    Preclinical • Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    Tibsovo (ivosidenib) • Voranigo (vorasidenib)
    1m
    A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment (clinicaltrials.gov)
    P1, N=30, Recruiting, Servier Bio-Innovation LLC
    Trial initiation date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib)
    1m
    DECISIVO: Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, PETHEMA Foundation
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    cytarabine • Tibsovo (ivosidenib) • Inqovi (decitabine/cedazuridine) • hydroxyurea
    1m
    Circulating tumor DNA-based detection of molecular residual disease in isocitrate dehydrogenase-mutant cholangiocarcinoma for biomarker-guided therapy. (PubMed, Clin Transl Oncol)
    Current first-line therapy for advanced IDH1-mutant disease includes gemcitabine plus cisplatin combined with either durvalumab or pembrolizumab. Ivosidenib is commonly used as a second-line targeted therapy...More prospective clinical trials are needed to validate ctDNA-guided risk stratification, support treatment decisions on adjuvant therapy escalation or de-escalation, and enable treatment adaptation in IDH-mutant CCA, ultimately advancing precision oncology beyond the capabilities of imaging alone. This review aims to evaluate the potential of ctDNA-based MRD detection to refine precision treatment strategies in IDH-mutant CCA.
    Review • Journal • PD(L)-1 Biomarker • Circulating tumor DNA
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation
    |
    Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • Tibsovo (ivosidenib)
    1m
    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
    |
    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
    Targeted Therapy in Acute Myeloid Leukemia: Current Approaches and Novel Directions. (PubMed, J Pers Med)
    Here, we detail the current targeted therapies available for AML: specifically, those targeting the BCL2 family (venetoclax), FLT3 (midostaurin, gilteritinib, quizartinib), IDH1/2 (enasidenib, ivosidenib), and MENIN (revumenib, ziftomenib). In addition, we outline potential mechanisms of resistance against these therapies, as well as efforts being taken to prevent or bypass them.
    Review • Journal • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • BCL2 (B-cell CLL/lymphoma 2) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    Venclexta (venetoclax) • Xospata (gilteritinib) • midostaurin • Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Revuforj (revumenib) • Idhifa (enasidenib) • Komzifti (ziftomenib)
    2ms
    Lessons from Exceptional Responders with High-Grade Brain Tumors Treated with Precision Targeted Therapies. (PubMed, J Immunother Precis Oncol)
    Standard-of-care surgery, radiation, and temozolomide yield a median survival of 14-16 months in patients with glioblastoma (GBM)...NGS yielded actionable alterations targeted after conventional surgery/chemoradiation therapy: imatinib (for KIT and PDGRA amplification) and bevacizumab (for KDR [VEGFR2] amplification); everolimus (mTOR inhibitor for TSC2 and PTEN loss-of-function alterations); and ivosidenib (IDH1 inhibitor for IDH1 mutations in two cases, including the oligosarcoma). Three patients remain in radiographic and clinical remission at 39+, 48, and 52+ months; the patient with oligosarcoma showed clinical and imaging response lasting 8 months. Our exceptional responders with high-grade gliomas suggest that biomarker-matched targeted therapy can benefit select patients with high-grade glioma and warrants prospective clinical trials.
    Journal
    |
    PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • KDR (Kinase insert domain receptor) • TSC2 (TSC complex subunit 2)
    |
    IDH1 mutation • EGFR amplification
    |
    Avastin (bevacizumab) • imatinib • everolimus • temozolomide • Tibsovo (ivosidenib)