^
19h
New P2 trial
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 R132
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Venclexta (venetoclax) • azacitidine • Tibsovo (ivosidenib)
20h
Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation (clinicaltrials.gov)
P1, N=15, Recruiting, Virginia Commonwealth University | Not yet recruiting --> Recruiting | Trial completion date: Oct 2029 --> Oct 2030 | Trial primary completion date: Oct 2027 --> Oct 2028
Enrollment open • 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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Rezlidhia (olutasidenib)
1d
Quantitative benefit-risk assessment of data from the phase III ClarIDHy study of ivosidenib versus placebo in patients with mIDH1 cholangiocarcinoma. (PubMed, ESMO Gastrointest Oncol)
Similarly, the random weights analysis favored ivosidenib with all evaluated weights and results converging quickly towards the main analysis results. These results provide comprehensive evidence that ivosidenib is an effective treatment with a tolerable safety profile for this aggressive disease, supporting previous data (ClinicalTrials.gov NCT02989857).
P3 data • Journal • Benefit-risk assessment
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 mutation
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Tibsovo (ivosidenib)
3d
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas (clinicaltrials.gov)
P1, N=47, Active, not recruiting, Daiichi Sankyo | Phase classification: P=N/A --> P1
Phase classification
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 R132
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safusidenib (DS-1001)
4d
VIGOR: Vorasidenib Maintenance for IDH Mutant Astrocytoma (clinicaltrials.gov)
P3, N=468, Recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting --> Recruiting
Enrollment open
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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IDH2 mutation
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Voranigo (vorasidenib)
5d
18F-DOPA-PET and advanced MRI improve treatment response assessment in IDH1/2-mutant gliomas treated with IDH inhibitors. (PubMed, Clin Cancer Res)
These results highlight the potential of ¹⁸F-DOPA-PET and advanced MRI sequences as valuable complements to standard RANO 2.0 MRI evaluations for assessing treatment response in glioma patients undergoing IDHi therapy.
Journal
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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Tibsovo (ivosidenib) • Voranigo (vorasidenib)
7d
Prospective, Single-Center, Single-Arm Clinical Study of Ivosidenib (AK112) Combined with Chemotherapy for Neoadjuvant Treatment of Locally Advanced Oral Squamous Cell Carcinoma (ChiCTR2600117076)
P4, N=15, Not yet recruiting, The first affiliated hostipal of nanchang university; The first affiliated hostipal of nanchang university
New P4 trial
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carboplatin • paclitaxel • docetaxel • pemetrexed • Tibsovo (ivosidenib) • Yidafan (ivonescimab)
9d
Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial. (PubMed, Nat Commun)
Olutasidenib was well tolerated and conferred disease control in cCS. Study limitations include open-label design and low patient sample due to rarity of cCS.
P1/2 data • Journal
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 mutation
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Rezlidhia (olutasidenib)
10d
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib (clinicaltrials.gov)
P=N/A, N=0, Withdrawn, Duke University | N=40 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 mutation
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Tibsovo (ivosidenib)
10d
Current Pharmacotherapeutic Strategies in Diffuse Gliomas: Focus on Glioblastoma, IDH-Wildtype, and Emerging Targeted Therapies for IDH-Mutant Tumors. (PubMed, Pharmaceuticals (Basel))
This review focuses on contemporary pharmacotherapeutic approaches used in the management of glioblastoma, IDH-wildtype, including temozolomide-based chemotherapy, corticosteroids for edema control, and antiangiogenic therapy in recurrent disease, with particular emphasis on their clinical efficacy and limitations...Particular attention is given to ivosidenib, a selective inhibitor of mutant IDH1, currently evaluated for the treatment of astrocytoma, IDH-mutant, grade 4...Finally, innovative drug-delivery technologies designed to overcome the blood-brain barrier are briefly discussed as complementary strategies that may enhance the efficacy of both conventional and targeted therapies. Overall, future advances in the treatment of diffuse gliomas will likely depend on the integration of molecularly targeted agents, predictive biomarkers, and advanced delivery platforms aimed at improving patient survival and quality of life.
Review • Journal
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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IDH1 mutation • IDH wild-type
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temozolomide • Tibsovo (ivosidenib)
11d
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) (clinicaltrials.gov)
P3, N=365, Recruiting, Nuvation Bio Inc. | Phase classification: P2 --> P3 | N=125 --> 365 | Trial completion date: Mar 2028 --> Dec 2030 | Trial primary completion date: Dec 2027 --> Dec 2028
Phase classification • Enrollment change • Trial completion date • Trial primary completion date
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • ATRX (ATRX Chromatin Remodeler)
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IDH1 mutation • IDH1 R132
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temozolomide • safusidenib (DS-1001)
15d
Single-cell proteogenomic analysis of clonal evolution in PDX models of AML treated with IDH inhibitors. (PubMed, Blood Neoplasia)
Using these models, we tracked clonal evolution under selective pressure from IDH inhibitors and combination therapies, identifying an association between WT1 mutations and ivosidenib (IDH1 inhibitor) monotherapy resistance, as well as an antagonism between ivosidenib and enasidenib (IDH2 inhibitor) when tested in IDH1-mutated cells. Our findings demonstrate how single-cell proteogenomic analysis of PDX models can illuminate drug resistance mechanisms and inform therapeutic strategies.
Journal
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • WT1 (WT1 Transcription Factor)
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IDH1 mutation
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Tibsovo (ivosidenib) • Idhifa (enasidenib)