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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
2d
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
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 mutation • IDH1 R132
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Tibsovo (ivosidenib)
4d
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
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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Tibsovo (ivosidenib) • Voranigo (vorasidenib)
16d
Trial initiation date
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 R132
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Tibsovo (ivosidenib)
20d
New P2 trial
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 R132
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cytarabine • Tibsovo (ivosidenib) • Inqovi (decitabine/cedazuridine) • hydroxyurea
22d
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
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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IDH1 mutation
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Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • Tibsovo (ivosidenib)
26d
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)
26d
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
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FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • BCL2 (B-cell CLL/lymphoma 2) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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Venclexta (venetoclax) • Xospata (gilteritinib) • midostaurin • Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Revuforj (revumenib) • Idhifa (enasidenib) • Komzifti (ziftomenib)
29d
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
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PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • KDR (Kinase insert domain receptor) • TSC2 (TSC complex subunit 2)
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IDH1 mutation • EGFR amplification
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Avastin (bevacizumab) • imatinib • everolimus • temozolomide • Tibsovo (ivosidenib)
29d
Breast cancer tumor immune microenvironment landscape identifies prognostic risk genes and potential drugs. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci)
Furthermore, fourteen candidate drugs targeting this network were predicted, and structural analogs of Lumacaftor and Ivosidenib showed promising docking affinities to CD1C and CXCR3, respectively. These findings provide preliminary insights into TIM-associated prognostic pathways and suggest candidate compounds for further investigation in BRCA.
Journal
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BRCA (Breast cancer early onset) • CD69 (CD69 Molecule) • CD40LG (CD40 ligand) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • CD1C (CD1c Molecule)
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Tibsovo (ivosidenib)
1m
New P1 trial
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 R132
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Tibsovo (ivosidenib)
1m
The allosteric IDH1 inhibitor ivosidenib overcomes chemoresistance in intrahepatic cholangiocarcinoma models expressing wild-type IDH1. (PubMed, J Clin Invest)
Gemcitabine-based chemotherapy is the standard treatment regime for advanced intrahepatic cholangiocarcinoma (iCCA), but the frequent presence of chemoresistance limits its efficacy. The low level of Mg2+, an ion that competitively hinders binding of ivosidenib on wtIDH1, in iCCA tumor microenvironment contributed to the expanded therapeutic window of ivosidenib in patients with iCCA. Our work revealed the potency of combining targeting IDH1 and chemotherapy against wtIDH1 iCCA and other tumors.
Journal
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH wild-type
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gemcitabine • Tibsovo (ivosidenib)
1m
New P2 trial
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 R132
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Tibsovo (ivosidenib) • Onureg (azacitidine oral)