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Association details:
| Biomarker: | IDH1 mutation |
|---|---|
| Cancer: | Myelodysplastic Syndrome |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Tibsovo (ivosidenib) (IDH1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
Excerpt:
......
Trial ID:
Source:
Title:
A study to investigate the effect of adding venetoclax to treatment with ivosidenib and azacitidine in patients with acute myeloid leukemia (AML) with a specific gene abnormality who have not previously been treated and who are not eligible for intensive chemotherapy.
Excerpt:
......
Trial ID:
Less C2 evidence
Source:
Title:
A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated myeloid malignancies
Published date:
04/27/2023
Excerpt:
The safety and efficacy of combining the IDH1 inhibitor ivosidenib (IVO) with the BCL2 inhibitor venetoclax (VEN; IVO+VEN) +/- azacitidine (AZA; IVO+VEN+AZA) was evaluated in four cohorts of patients with IDH1-mutated myeloid malignancies…Composite complete remission with IVO+VEN+AZA vs. IVO+VEN was 90% vs. 83%....No IDH isoform switching or second-site IDH1 mutations were observed, indicating combination therapy may overcome established resistance pathways to single-agent IVO.
Secondary therapy:
azacitidine
DOI:
10.1158/2643-3230.BCD-22-0205
Source:
Title:
A Phase Ib/II Study of Ivosidenib With Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies
Published date:
09/21/2022
Excerpt:
Eligible patients were ≥ age 18 with IDH1+ MDS...The ORR was 94% (DL1: 67%, DL2–DL4:100%); composite CR (CRc: CR+CRi+CRh) was 87% (DL1: 67%,DL2: 100%, DL3: 85%, DL4: 100%)….IVO+VEN±AZA is an effective treatment for IDH1+ myeloid malignancies with an expected toxicity profile and notable activity across disease groups.
Source:
Title:
A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated myeloid malignancies.
Published date:
05/19/2021
Excerpt:
Eligible patients age ≥18 with IDH1+ MDS, newly diagnosed AML (ND: treatment naïve [TN] or secondary/treated secondary AML [sAML]), or relapsed/refractory (R/R) AML enrolled into three dose levels (DL): DL1 (IVO+VEN 400 mg), DL2 (IVO+VEN 800 mg), DL3 (IVO+VEN 400 mg+AZA)...The ORR was 92% (DL1: 67%, DL2: 100%, DL3: 100%)...IVO+VEN +/- AZA is an effective treatment regimen in patients with IDH1+myeloid malignancies.
DOI:
10.1200/JCO.2021.39.15_suppl.7012
Trial ID:
Source:
Title:
A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated myeloid malignancies.
Published date:
05/19/2021
Excerpt:
Eligible patients age ≥18 with IDH1+ MDS, newly diagnosed AML (ND: treatment naïve [TN] or secondary/treated secondary AML [sAML]), or relapsed/refractory (R/R) AML enrolled into three dose levels (DL): DL1 (IVO+VEN 400 mg), DL2 (IVO+VEN 800 mg), DL3 (IVO+VEN 400 mg+AZA)...The ORR was 92% (DL1: 67%, DL2: 100%, DL3: 100%)...IVO+VEN +/- AZA is an effective treatment regimen in patients with IDH1+myeloid malignancies.
Secondary therapy:
azacitidine
DOI:
10.1200/JCO.2021.39.15_suppl.7012
Trial ID:
Source:
Title:
A PHASE IB/II STUDY OF IVOSIDENIB WITH VENETOCLAX +/- AZACITIDINE IN IDH1-MUTATED MYELOID MALIGNANCIES
Published date:
05/12/2021
Excerpt:
Eligible patients age ≥18 with IDH1+ MDS, newly diagnosed (ND: treatment naïve [TN], secondary/treated secondary AML [sAML]), or relapsed/refractory (R/R) AML were enrolled into three dose levels (DL): DL1 (IVO+VEN 400 mg), DL2 (IVO+VEN 800 mg), DL3 (IVO+VEN 400 mg+AZA)… IVO+VEN +/- AZA is an effective treatment regimen in patients with IDH1+ myeloid malignancies.
Source:
Title:
A PHASE IB/II STUDY OF IVOSIDENIB WITH VENETOCLAX +/- AZACITIDINE IN IDH1-MUTATED MYELOID MALIGNANCIES
Published date:
05/12/2021
Excerpt:
Eligible patients age ≥18 with IDH1+ MDS, newly diagnosed (ND: treatment naïve [TN], secondary/treated secondary AML [sAML]), or relapsed/refractory (R/R) AML were enrolled into three dose levels (DL): DL1 (IVO+VEN 400 mg), DL2 (IVO+VEN 800 mg), DL3 (IVO+VEN 400 mg+AZA)… IVO+VEN +/- AZA is an effective treatment regimen in patients with IDH1+ myeloid malignancies.
Secondary therapy:
azacitidine