Orizen Genomics, a clinical-stage biopharmaceutical company focused on epigenetics for the treatment of diseases with significant unmet medical needs, presented a poster of its ongoing FRIDA clinical trial titled Iadademstat in combination with gilteritinib for patients with leukemia has announced. Refractory Acute Myeloid With/FLT3 Mutation at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, to be held in person in Chicago, Illinois, June 2-6, 2023.
He Dr. Amir Fathi, director of the Massachusetts General Hospital Leukemia Program, is the principal investigator of the study and first author of the poster. Dr. Fathi will record a short video summarizing the information on the poster and the status of the study.
He Dr. Douglas V. Fowler, Orizen Global Medical DirectorWill participate in a poster presentation, which will take place on Monday, June 5 from 8:00 to 11:00 a.m. local time in the Scientific Poster Discussion session, within the session on Hematological Neoplasms—Leukemia, Myelodysplastic Syndrome, and Allografts.
FRIDA (NCT05546580) is a multicentre, open-label study of iadademstat in combination with gilteritinib for the treatment of patients with relapsed/refractory acute myeloid leukemia (R/R AML) with FLT3 mutations. The primary objectives of the study are to assess the safety and tolerability of iadademstat in combination with gilteritinib in patients with FLT3-mutant R/R AML and to establish a recommended phase 2 dosage (RP2D) for this combination. Secondary study objectives include evaluation of treatment efficacy, measured as the rate of complete remission and partial hematologic recovery (CR/CRH), duration of responses (DOR), and measurable residual disease (MRD). is included. FRIDA will be held at 10-15 centers in the US. The study is expected to enroll approximately 45 patients, and in the event of a positive result, the company and the FDA have agreed to hold a meeting to discuss the best plan for further development. The combination of this study therefore highlights the need for new treatments for this population of patients with AML.