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|Molecular Profile||Indication/Tumor Type||Response Type||Relevant Treatment Approaches||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|IDH1 R132G||acute myeloid leukemia||sensitive||IDH1 Inhibitor||Ivosidenib||FDA approved - On Companion Diagnostic||Actionable||In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839).||detail... 29860938 detail...|
|IDH1 R132G||acute myeloid leukemia||sensitive||IDH1 Inhibitor||Ivosidenib||FDA approved - On Companion Diagnostic||Actionable||In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 28.6% (8/28), CR with partial hematological recovery (CRh) in 14.3% (4/28) of patients age 75 or older with untreated acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test, with a median treatment duration of 4.3 months (PMID: 29860938; NCT02074839).||detail... 29860938 detail...|
|IDH1 R132G||acute myeloid leukemia||sensitive||IDH1 Inhibitor||BAY1436032||Preclinical - Patient cell culture||Actionable||In a preclinical study, BAY1436032 decreased (R)-2-hydroxyglutarate (R-2HG) levels and increased differentiation of patient-derived acute myeloid leukemia cells harboring IDH1 R132G in culture (PMID: 28232670).||28232670|
|IDH1 R132G||chondrosarcoma||predicted - sensitive||IDH1 Inhibitor||Ivosidenib||Case Reports/Case Series||Actionable||In a Phase I trial, Tibsovo (ivosidenib) treatment was tolerated, substantially decreased plasma 2-HG levels, and resulted in a median progression-free survival of 5.6 months and stable disease in 52% (11/21) of patients with chondrosarcoma harboring IDH1 mutations, including IDH1 R132G (n=3) (PMID: 32208957; NCT02073994).||32208957|
|IDH1 R132G||cholangiocarcinoma||predicted - sensitive||IDH1 Inhibitor||Ivosidenib||Phase III||Actionable||In a Phase III (ClarIDHy) trial, Tibsovo (ivosidenib) treatment significantly improved median progression-free survival (2.7 vs 1.4 mo, HR=0.37, p<0.001) and prolonged median overall survival (10.8 vs 9.7 mo, HR=0.69, p=0.06) compared to placebo in patients with advanced cholangiocarcinoma harboring IDH1 mutations including R132C/L/G/S, resulted in favorable objective response rate (2%, 3/124 vs 0%, 0/61) and stable disease rate (51% vs 28%) (PMID: 32416072; NCT02989857).||32416072|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT04164901||Phase III||AG-881||Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)||Recruiting|
|NCT04088188||Phase I||Cisplatin + Gemcitabine + Pemigatinib Cisplatin + Gemcitabine + Ivosidenib||Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma||Not yet recruiting|
|NCT04056910||Phase II||Ivosidenib + Nivolumab||Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors||Not yet recruiting|
|NCT03953898||Phase II||Olaparib||Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation||Recruiting|