FDA Puts Partial Hold on Study of Emavusertib in AML/MDS

The U.S. Food & Drug Administration (FDA) has placed a partial clinical hold on Curis’ TakeAim Leukemia phase I/IIa clinical trial of emavusertib after the death of a patient who experienced, among several conditions, rhabdomyolysis, which has previously been identified as a dose-limiting toxicity of the drug.

The clinical trial is an open-label, single-arm dose-escalation/expansion study of emavusertib as monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).

The partial hold allows no new patients to be enrolled in the study. Current participants benefitting from treatment may continue to be treated with emavusertib at doses of 300 mg twice daily or lower.

The FDA is requesting additional data from the study, including data related to the death of the patient. The agency is also requesting safety and efficacy, as well as a data related to rhabdomyolysis and the recommended phase II dose.

Curis has also decided to pause enrollment of new patients on its TakeAim Lymphoma study, which is investigating emavusertib in patients with B-cell malignancies.

Source: Curis press release, April 2022