Phase 1 Study of the IDH1m Inhibitor FT-2102 As a Single Agent in Patients with IDH1m Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Conclusions: FT-2102 preclinical evaluations suggest a low risk of clinically significant CYP-mediated drug-drug interaction and QTc prolongation. SA FT-2102 is well tolerated in AML and MDS, with 150 mg BID selected as the RP2D based on safety, PK and PD (2-HG) response. Significant clinical activity has been observed in heavily pre-treated and in TN patients, both in AML and MDS. FT-2102 continues being investigated at a dose of 150 mg BID in a Phase 2 study. Three SA Phase 2 cohorts are currently open for enrollment in R/R AML, AML/MDS with CR/CRi (i.e., with MRD), and in pts with R/R MDS/AML with prior exposure to an IDH1m inhibitor. Data updates will be available at the time of presentation.DisclosuresLee: LAM Therapeutics: Research Funding; Karyopharm Therapeutics Inc: Consultancy; AstraZeneca: Consultancy; Clinipace: Consultancy; Amgen: Consultancy. Schiller: Celator/Jazz Pharmaceuticals: Research Funding; Pharmacyclics: Research Funding. Ferrell: Incyte: Research Funding. Kelly: Forma Therapeutics Inc.: Employment. Li: Forma Therapeutics Inc.: Employment. Sweeney: Forma Therapeutics Inc.: Employment. Watson: Forma Therapeutics Inc.: Employment. Mohamed: Forma Therapeutics Inc.: Employment. Cortes: Pfizer: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Astellas Pharma: Consultancy, Research Funding; Arog: Research Funding.

Source: Blood - November 21, 2018 Category: Hematology Authors: Watts, J., Baer, M. R., Yang, J., Dinner, S., Lee, S., Seiter, K., Prebet, T., Schiller, G. J., Ferrell, P. B., Dao, K.-H., Kantarjian, H. M., Kelly, P., Li, P., Sweeney, J., Watson, C., Mohamed, H., Cortes, J. E. Tags: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I Source Type: research