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Association details:
| Biomarker: | IDH2 mutation |
|---|---|
| Cancer: | Myelodysplastic Syndrome |
| 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:
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:
More C2 evidence
Source:
Title:
A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients
Excerpt:
...Subject has IDH2 gene mutations revealed by local testing in samples of bone marrow aspirate and/or peripheral blood, and confirmed positive in bone marrow aspirate and/or peripheral blood....
Trial ID:
Source:
Title:
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
Excerpt:
...- Subjects must have documented IDH2 gene mutation...
Trial ID:
Source:
Title:
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
Excerpt:
...Arm 2: Relapsed or refractory AML and age 4: Isocitrate dehydrogenase protein, 2 (IDH2)-mutated advanced hematologic malignancies...
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:
Source:
Title:
study of the efficacy of treatment with AG-221 in patients with myelodysplastic syndrome and mutation IDH2
Excerpt:
...• Presence of IDH2 mutation in either blood or marrow prior to start of therapy• Normal renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance (Modification of diet in renal disease) (MDRD) ≥ 50 mL/min. ...
Trial ID:
Source:
Title:
IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome
Excerpt:
......
Trial ID:
Source:
Title:
Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation
Excerpt:
...Negative for IDH2 mutation by NGS or multiplex PCR (SNaPshot) 6....
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:
Less C2 evidence
Source:
Title:
Targeted therapy with the mutant IDH2 inhibitor enasidenib for high-risk IDH2-mutant myelodysplastic syndrome
Published date:
05/26/2023
Excerpt:
We designed a 2-arm multicenter study to evaluate safety and efficacy of (A) the combination of enasidenib with azacitidine for newly diagnosed mIDH2 MDS, and (B) enasidenib monotherapy for mIDH2 MDS...Median time to first response was 27 days, and time to best response was 4.6 months (2.7-7.6 months). A median of 7 cycles was received (range, 1-29), and the median OS was 20 months...Enasidenib is an effective treatment option for mIDH2 MDS, both in combination with azacitidine for treatment-naïve high-risk MDS...
DOI:
10.1182/bloodadvances.2022008378
Trial ID:
Source:
Title:
Phase II Study of the IDH2 Inhibitor Enasidenib in Patients with HighRisk IDH2-Mutated Myelodysplastic Syndromes (MDS)
Published date:
09/01/2021
Excerpt:
48 pts received ENA+AZA (n = 26) or ENA (n = 22)….In response-evaluable pts (n = 46), ORR was 84% (n = 21/25; 24% CR + 8% PR+44% mCR+ 8% HI] in the treatment-naïve Arm A and 43% (n = 9/21; 24% CR+5%PR+5% mCR+10% HI) in the HMA failure ENA arm B. After a median follow-up of 12.6 mo, median OS was 32.2 mo in the ENA+AZA arm and 21.3 mo in the ENA arm....ENA is well-tolerated and shows promising efficacy in IDH2-mutated higher-risk MDS...
Secondary therapy:
azacitidine
Trial ID:
Source:
Title:
MDS-090: Phase II Study of the IDH2 Inhibitor Enasidenib in Patients with High-Risk IDH2-Mutated Myelodysplastic Syndromes (MDS)
Published date:
09/01/2021
Excerpt:
In response-evaluable pts (n = 46), ORR was 84% (n = 21/25; 24% CR + 8% PR+44% mCR+ 8% HI] in the treatment-naïve Arm A and 43% (n = 9/21; 24% CR+5%PR+5% mCR+10% HI) in the HMA failure ENA arm B. After a median follow-up of 12.6 mo, median OS was 32.2 mo in the ENA+AZA arm and 21.3 mo in the ENA arm.ENA is well-tolerated and shows promising efficacy in IDH2-mutated higher-risk MDS. Follow-up and accrual are ongoing.
Secondary therapy:
azacitidine
DOI:
https://doi.org/10.1016/S2152-2650(21)01791-2
Trial ID:
Source:
Title:
Phase II study of the IDH2-inhibitor enasidenib in patients with high-risk IDH2-mutated myelodysplastic syndromes (MDS).
Published date:
05/19/2021
Excerpt:
...efficacy and tolerability of ENA, as monotherapy or in combination with azacitidine (AZA) in pts with higher-risk IDH2-mutated MDS...In response-evaluable pts (n=46), ORR was 84% (n = 21/25; 24% CR + 8% PR+44% mCR+ 8% HI] in the treatment naïve ENA+AZA...After a median follow up of 12.6 mo, median OS was 32.2 mo in the ENA+AZA and 21.3 mo in the ENA arm...ENA is well tolerated and shows promising efficacy in IDH2-mutated higher risk MDS.
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.2021.39.15_suppl.7010
Trial ID:
Source:
Title:
PHASE II STUDY OF THE IDH2-INHIBITOR ENASIDENIB IN PATIENTS WITH HIGH-RISK IDH2-MUTATED MYELODYSPLASTIC SYNDROMES (MDS)
Published date:
05/12/2021
Excerpt:
…efficacy and tolerability of ENA, as monotherapy or in combination with azacitidine (AZA) in pts with higher-risk IDH2-mutated MDS….After a median follow up of 12.6 mo, median OS was 32.2 mo in the ENA+AZA and 21.3 mo in the ENA arm….ENA is well tolerated and shows promising efficacy in IDH2-mutated higher risk MDS.
Secondary therapy:
azacitidine
Trial ID:
