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Association details:
| Biomarker: | IDH2 R172 |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Idhifa (enasidenib) (IDH2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Overall survival by IDH2 mutant allele (R140 or R172) in patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib or conventional care regimens in the phase 3 IDHENTIFY trial.
Published date:
05/26/2022
Excerpt:
...patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib...a trend for improved OS with ENA was detected in pts with IDH2-R172 mutations....ENA improved survival outcomes for pts with IDH2-R172 mutations, with median OS and 1-year survival rate approximately double those in the CCR arm.
DOI:
10.1200/JCO.2022.40.16_suppl.7005
Trial ID:
Source:
Title:
A PHASE 3 STUDY OF ENASIDENIB (ENA) VERSUS CONVENTIONAL CARE REGIMENS (CCR) IN OLDER PATIENTS WITH LATE-STAGE MUTANT-IDH2 (MIDH2) RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R AML)
Published date:
05/12/2021
Excerpt:
In mIDH2-R172 pts, median OS was ~2-fold longer with ENA (n=43) vs CCR (n=45): 14.6 vs 7.8 mo (HR 0.59; P=0.039)....ENA provided meaningful improvements in 1-yr survival, EFS, and morphologic response vs CCR, and ENA prolonged OS for pts preselected to lower-intensity Tx and pts with mIDH2-R172 AML.
Source:
Title:
IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation
Excerpt:
...- IDH2 mutations will include any IDH2 R140 or R172 alterations...
Trial ID:
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:
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:
Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia
Excerpt:
The ORR for patients with IDH2-R140 mutations 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:
