On December 10, 2024 Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported data from the TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) at the 66th ASH (Free ASH Whitepaper) annual meeting (Press release, Curis, DEC 10, 2024, View Source [SID1234648969]).

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The additional data presented include data for 21 patients with a FLT3 mutation (FLT3m) who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID. This brings the total number of patients dosed at the RP2D from 12 to 21 patients.

Data show 10 objective responses in 19 response-evaluable patients: 6 complete remission (CR), 2 CR with either a complete remission with incomplete hematological recovery (CRi) or a partial hematological recovery (CRh) and 2 morphologic leukemia-free state (MLFS). Prior therapies of responders included Venetoclax (5/10), HMA (6/10), and FLT3i (6/10). Two of the 21 patients were treated, but discontinued treatment prior to first disease assessment (death occurred at Day 8 and Day 13, respectively), and were not included as response-evaluable patients.

Two patients who achieved a CR and CRi, respectively, proceeded to allogenic stem cell transplantation. Responses were achieved rapidly in this population, with 7 of 10 responses reported at the first assessment (Cycle 2 Day 1).

"We continue to be pleased with the monotherapy data in R/R AML patients with a FLT3 mutation," said James Dentzer, President and CEO of Curis, "and believe these data further support the exciting potential of emavusertib’s novel mechanism to address a significant unmet need in patients with AML."