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FDA lifts clinical hold on phase I study of FHD-286 in patients with R/R AML or MDS
On June 1, 2023, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the phase I dose escalation study of FHD-286, a highly potent, selective, allosteric, orally available inhibitor of BRG1 (SMARCA4) and BRM (SMARCA2) for the treatment of patients with relapsed and/or refractory (R/R) acute myeloid leukemia (AML) (NCT04891757).1
Following initiation of a partial clinical hold on May 19, 2022,2 the FDA then placed a full clinical hold on the phase I study on August 23, 2022, due to suspected cases of fatal differentiation syndrome.3 In response to the clinical hold, an independent adjudication committee of leading AML experts determined that the rate of differentiation syndrome was 15%, with one case considered definitive for differentiation syndrome but not contributing to the patient’s death.1
The clinical hold has been lifted following protocol amendments and plans to initiate a phase I study of FHD-286 in combination with decitabine or low-dose cytarabine in patients with R/R AML.1 Decitabine and cytarabine are cytoreductive and may reduce the risk of differentiation syndrome. This phase I combination study, to assess the safety, tolerability, and efficacy of FHD-286 in R/R AML, is expected to begin later in 2023; patients will receive a dose escalation of FHD-286 with fixed-dose decitabine or fixed-dose cytarabine in a 3+3 dose escalation design.1
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Approximately what proportion of your patients with FLT3-mutations also have NPM1 and DNMT3A co-mutations?
