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Association details:
| Biomarker: | IDH1 mutation |
|---|---|
| Cancer: | Myelodysplastic Syndrome |
| Drug: | Tibsovo (ivosidenib) (IDH1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
10/24/2023
Excerpt:
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test...for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes.
Test:
Source:
Published date:
11/10/2023
Excerpt:
Myelodysplastic Syndromes: For mIDH1, added: ivosidenib as a category 2A recommendation.
Source:
Title:
Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO® (ivosidenib tablets) in the Treatment of IDH1-mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)
Published date:
08/15/2023
Excerpt:
Servier...announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for TIBSOVO (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). If approved, TIBSOVO would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset...These findings showed that in the efficacy analysis set (n=18), a complete remission (CR) rate of 38.9% and objective response rate (ORR) of 83.3% were documented in patients treated with TIBSOVO.
Source:
Title:
study of the efficacy of treatment with AG-120 in patients with myelodysplastic syndrome and mutation IDH1 L'étude de l'efficacité du traitement AG-120 chez les patients atteints de syndrome myélodysplasique et une mutation du gène IDH1
Excerpt:
...Untreated higher risk MDS (IPSS int-2, high) without life threatening cytopenia including ANC =60000 U/w) or Darbopoetin (>=250 ug/w) given for at least 12 weeks and RBC transfusion requirement at least 2 U/8 weeks in the previous 16 weeks •Presence of IDH1 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) creatinine clearance ≥ 50 mL/min. ...
Trial ID:
Source:
Title:
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Excerpt:
...Have an isocitrate dehydrogenase 1 (IDH1) mutation....
Trial ID:
More C2 evidence
Source:
Title:
IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation
Excerpt:
...IDH1 mutations could have been detected by any mutational technique at any prior point including at diagnosis or remission....
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:
IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome
Excerpt:
......
Trial ID:
Less C2 evidence
Source:
Title:
Ivosidenib in Mutant IDH1 Relapsed/ Refractory Myelodysplastic Syndrome: Updated Substudy Results
Published date:
09/01/2023
Excerpt:
IVO demonstrated an acceptable safety profile with durable remissions in a substantial proportion of patients with mIDH1 R/R MDS.
Trial ID:
Source:
Title:
UPDATED SUBSTUDY RESULTS FOR IVOSIDENIB IN IDH1-MUTANT RELAPSED/REFRACTORY MYELODYSPLASTIC SYNDROME
Published date:
05/11/2023
Excerpt:
This phase I, open-label multinational substudy is evaluating the safety, tolerability, and clinical activity of IVO in pts with mIDH1 R/R MDS….IVO induced durable remissions, including a substantial proportion of CRs, with an acceptable safety profile in pts with mIDH1 R/R MDS...
Source:
Title:
Ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS): Updated enrollment and results of a phase 1 dose-escalation and expansion substudy.
Published date:
05/26/2022
Excerpt:
7/16 pts achieved complete response (CR, 44%; 95% CI, 20%, 70%), 1 achieved partial response (6%), and 5 achieved marrow CR (31%), resulting in an ORR of 81% (95% CI, 54%, 96%)...In pts with mIDH1 R/R MDS, IVO monotherapy was tolerable and induced durable remissions and transfusion independence. These findings support the role of IVO as an effective, oral, targeted treatment for pts with mIDH1 R/R MDS.
DOI:
10.1200/JCO.2022.40.16_suppl.7053
Trial ID:
