Olutasidenib (FT2102)

Description: Olutasidenib (FT-2102) is a novel, highly potent and selective small molecue inhibitor of mutant Isocitrate dehydrogenase 1 (IDH1) with the potential to be used in the treatment of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Isocitrate dehydrogenase 1 mutations (IDH1m) occur in 7-14% of AML patients (pts) and 3% of MDS pts. FT-2102 has shown favorable safety, PK/PD, and clinical activity in IDH1m AML/MDS with a single agent complete response rate (CR/CRi) of 38% and a complete response rate of 27% in combination with AZA. Current data support the continued evaluation of 150 mg BID in the expansion and Phase 2 stages of the study.

References: A phase 1 dose escalation study of the IDH1m inhibitor, FT-2102, in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).