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Association details:
| Biomarker: | IDH1 R132 |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Tibsovo (ivosidenib) (IDH1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma
Published date:
05/10/2023
Excerpt:
Servier, a global pharmaceutical group, today announced that the European Commission (EC) has approved Tibsovo® (ivosidenib tablets) as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Secondary therapy:
azacitidine
Source:
Title:
A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML)
Excerpt:
...Subject has newly diagnosed, primary (ie, de novo) or secondary (progression of MDS or myeloproliferative neoplasms [MPN], or therapy-related) AML according to the WHO classification with ≥ 20% leukemic blasts in the bone marrow: -Have an Isocitrate dehydrogenase 1 (IDH1) or Isocitrate dehydrogenase 2 (IDH2) gene mutation (R132, R140, or R172) - IDH mutational status will be assessed locally; for sites without local testing capabilities, a referral lab will be identified. ...
Source:
Title:
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Excerpt:
...- Subjects must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation....
Trial ID:
More C2 evidence
Source:
Title:
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.
Excerpt:
...- Have a documented IDH1 R132 gene-mutated disease...
Trial ID:
Source:
Title:
Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia
Excerpt:
...- Patient must have documentation of an IDH1 R132 mutation obtained prior to registration....
Trial ID:
Source:
Title:
A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation
Excerpt:
...Subjects must have documented IDH1 R132 gene-mutated based on the central evaluation....
Trial ID:
Source:
Title:
Combination therapy of the PHD inhibitor molidustat with the IDH1 inhibitor ivosidenib in patients with relapsed/refractory AML or MDS/AML with IDH1 mutation.
Excerpt:
...IDH1-mutated as determined by a validated assay at a specific site (IDH1 R132).4. ...
Trial ID:
Source:
Title:
Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
Excerpt:
...Have documented IDH1 R132 gene-mutated disease....
Trial ID:
Less C2 evidence
Source:
Title:
Ivosidenib (IVO) in Combination with Azacitidine (AZA) in Newly Diagnosed (ND) Older Patients with IDH1 R132-Mutated Acute Myeloid Leukemia (AML) Induces High Response Rates: A Phase 2 Sub-Study of the Beat AML Master Trial
Published date:
11/04/2021
Excerpt:
In this Phase 2 sub-study of the Beat AML Master Trial, we evaluated the efficacy of IVO + AZA combination Tx in ND pts aged ≥60 years with IDH1m AML (ClinicalTrials.gov: NCT03013998)....Key eligibility included ND IDH1 R132 mutated AML pts aged ≥60 years...In ND pts with IDH1m AML and ≥60 years of age, IVO + AZA Tx was associated with a high CR/CRh/CRi rate, no early deaths (60 days) and a 1-year OS of 100%.
Secondary therapy:
azacitidine
DOI:
10.1182/blood-2021-149115
Trial ID:
