FDA Removes Partial Clinical Hold From TakeAim Leukemia Study

The US Food and Drug Administration (FDA) has removed the partial clinical hold on the TakeAim Leukemia phase I/II study of emavusertib, an orally bioavailable, reversible inhibitor of IRAK4, FLT3, and CLK for the treatment of hematologic malignancies.

The recommended phase II dose (RP2D) for emavusertib as a monotherapy has been established at 300 mg twice daily in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), according to Curis, the manufacturer of the drug.

“We are pleased to announce that [the] FDA has removed the partial clinical hold on the TakeAim Leukemia study, and that we are proceeding with 300 mg [twice daily] as our RP2D,” said James Dentzer, President and Chief Executive Officer of Curis. “We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received ≤2 prior lines of treatment).”

The FDA placed the partial clinical hold on April 4, 2022, following the death of a patient. On August 30, 2022, the FDA notified Curis that the company could resume enrolling additional patients in the monotherapy dose finding phase of the study.

The TakeAim Leukemia study is a multicenter, open-label, phase I/IIa dose-escalation and expansion study of orally administered emavusertib monotherapy and in combination with azacitidine or venetoclax in adult patients with AML or high-risk MDS. It is currently open for enrollment, along with the TakeAim Lymphoma study.

Source: Curis, July 2023