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Association details:
| Biomarker: | IDH2 R140 |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Idhifa (enasidenib) (IDH2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Trial evaluating the safety and efficacy of Enasidenib for the treatment of recurrence or prophylactic treatment of certain forms of leukemia following blood stem cell transplantation. Studie zur Bewertung der Sicherheit und Wirksamkeit von Enasidenib zur Behandlung von Rückfällen oder zur vorbeugenden Behandlung bestimmter Formen von Leukämie nach einer Blutstammzelltransplantation.
Excerpt:
...• Patients with myeloid malignancy (AML, MDS and CMML) and known IDH2 mutation (IDH2 R172 or R140 mutation) at diagnosis prior to first allo-SCT• hematological CR after allo-SCT determined during screening period between day+25 and day +35• Hematopoietic recovery after transplantation indicated by an absolute neutrophil count of at least 1.000/microliter and platelet count of at least 50.000/microliter• no previous therapy with Enasidenib or any other IDH2 inhibitor• ECOG performance status ≤ 2 at study entry (s. ...
Trial ID:
Source:
Title:
IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation
Excerpt:
...- Pathologically confirmed diagnosis of IDH2-mutant acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)....
Trial ID:
More C2 evidence
Source:
Title:
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
Excerpt:
...- Subjects must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result...
Trial ID:
Source:
Title:
IDH2-Post-Allo-Trial for Patients With IDH2-mut Myeloid Neoplasms After Allo-SCT
Excerpt:
...- Patients with myeloid malignancy (AML, MDS and CMML) and known IDH2 mutation (IDH2 R172 or R140 mutation) at diagnosis prior to first allo-SCT...
Trial ID:
Less C2 evidence
Source:
Title:
636 Enasidenib (ENA) Monotherapy with Addition of Azacitidine in Non-Responders Is Effective in Older Patients with Newly Diagnosed IDH2 Mutated Acute Myeloid Leukemia (AML): A Completed Phase 2/1b Sub-Study of the Beat AML Master Trial
Published date:
11/04/2020
Excerpt:
Responses were higher (p=0.04) among the 44 pts with IDH2 R140 (55%) as compared to the 16 with IDH2 R172 mutation (25%) further supporting distinct biology between these subsets....ENA had a low early death rate, high CR/CRi rate (47%, adjusted 95% CI 28-59), and yielded durable remissions.
Trial ID:
Source:
Title:
Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia
Excerpt:
The ORR for patients with IDH2-R172 mutationss was 35.4% (95% CI, 27.2%-44.2%) and for those with IDH2-R172 mutations, ORR was 53.3% (95% CI, 37.9%-68.3%). Rates of complete remission were 17.7% (95% CI, 11.6%-25.4%) in patients with IDH2-R140 mutations and 24.4% (95% CI, 12.9%-39.5%) for patients with IDH2-R172 mutations....In conclusion, data from this study showed that single-agent enasidenib was well tolerated, induced hematologic responses, and was associated with a median survival of more than 9 months in patients with relapsed or refractory mutant-IDH2 AML.
DOI:
10.1182/blood-2017-04-779405
Trial ID:
