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Association details:
| Biomarker: | IDH1 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | MEN1703 (FLT3 inhibitor, PIM inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase 1/2 Study of SEL24/MEN1703, a First-in-Class Dual PIM/FLT3 Kinase Inhibitor, in Patients With IDH1/2-Mutated Acute Myeloid Leukemia: The DIAMOND-01 Trial
Published date:
09/21/2022
Excerpt:
Of the 7 patients who completed ≥ 1 treatment cycle and had ≥1 postbaseline assessment or clear disease progression, ORR was 28.6%; 1 patient achieved a complete response with incomplete blood count recovery at cycle 3 and underwent hematopoietic stem cell transplant, and 1 patient had a partial response at cycle 4 (confirmed at cycle 7 and still on treatment)....SEL24/MEN1703 had a manageable safety profile and single-agent activity in adult patients with R/R IDHm AML and may be a feasible therapeutic option in this difficult-to-treat population.
Trial ID:
Source:
Title:
Phase 1/2 study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in patients with IDH1/2-mutated acute myeloid leukemia: The DIAMOND-01 trial.
Published date:
05/26/2022
Excerpt:
Of the 7 pts who completed ≥1 treatment cycle and had ≥1 post-baseline assessment or clear disease progression, ORR was 28.6%; 1 pt achieved CRi at cycle (C)...Preliminary results in the IDHm cohort confirm that SEL24/MEN1703, a first in class, orally available, dual PIM/FLT3 inhibitor, has a manageable safety profile and single-agent activity in pts with R/R IDHm AML.
DOI:
10.1200/JCO.2022.40.16_suppl.7024
Trial ID:
Source:
Title:
PHASE 1/2 STUDY OF SEL24/MEN1703, A FIRST-IN-CLASS DUAL PIM/FLT3 KINASE INHIBITOR, IN PATIENTS WITH IDH1/2-MUTATED ACUTE MYELOID LEUKEMIA: THE DIAMOND-01 TRIAL.
Published date:
05/12/2022
Excerpt:
Of the 7 patients who completed ≥1 treatment cycle and had ≥1 post baseline assessment or clear disease progression, ORR was 28.6%; 1 patient achieved a complete response with incomplete blood count recovery (CRi) at cycle 3 and underwent hematopoietic stem cell transplant, 1 patient had a partial response at cycle 4 (confirmed at cycle 7 and still on treatment)...Preliminary results in the IDHm cohort confirm that SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, has a manageable safety profile and single-agent activity in patients with R/R IDHm AML.
Source:
Title:
Updated results from DIAMOND-01 (CLI24-001) trial: A phase I/II study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in acute myeloid leukemia.
Published date:
05/19/2021
Excerpt:
Responses occurred in 2 pts in the CE, both with IDH1 mutant disease (naïve to IDH inhibitors) who achieved complete remission with incomplete hematologic recovery (CRi)...SEL24/MEN1703 confirmed a manageable safety profile at RD and showed preliminary single agent efficacy in R/R AML, particularly clustering in pts with IDH mutant disease either naïve or previously exposed to IDH inhibitors.
DOI:
10.1200/JCO.2021.39.15_suppl.7023
Trial ID:
Source:
Title:
RESULTS FROM DIAMOND-01 (CLI24-001) TRIAL: FIRST IN HUMAN STUDY OF SEL24/MEN1703, A DUAL PIM/FLT3 KINASE INHIBITOR, IN PATIENTS WITH ACUTE MYELOID LEUKEMIA
Published date:
05/12/2021
Excerpt:
Responses occurred in 2 pts in the CE, both with IDH1 mutant disease (naive to IDH inhibitors) who achieved complete remission with incomplete hematologic recovery (CRi)....SEL24/MEN1703 confirmed a manageable safety profile at RD and showed preliminary single agent efficacy in R/R AML, particularly clustering in pts with IDH mutant disease either naive or previously exposed to IDH inhibitors.
Trial ID:
