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Agios' (AGIO) Phase 1 TIBSOVO (ivosidenib) Treatment in IDH1 Mutant Acute Myeloid Leukemia (AML) Translational Data Released

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Clinical Data Results from the study show a complete response (CR) rate of 61% and a CR + CR with partial hematologic recovery (CRh) rate of 70%. Responses were durable, and the median duration of CR (95% CI 9.3 months, NE) as well as CR+CRh (95% CI 12.2 months, NE) had not been reached. In patients with CR, 10 of 14 (71%) had IDH1 mutation clearance in bone marrow mononuclear cells measured by BEAMing digital PCR (limit of detection 0.02-0.04%). Additionally, the majority of CR patients with IDH1 mutation clearance demonstrated measurable residual disease (MRD) negativity by flow cytometry or next-generation sequencing. Five patients were shown to have RTK pathway mutations (KRAS, NRAS, PTPN11), and three of these patients achieved CR/CRh with TIBSOVO® and azacitidine combination therapy.
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Occurred on:
Dec 09, 2019
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Related Keywords Idh1 Mutation, Acute Myeloid Leukemia, Tibsovo, Ivosidenib