Curis, Inc. announced updated data from the ongoing TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) AML to be presented at the ASCO and EHA conferences. This update includes data for 25 new patients in the FLT3 mutation (FLT3m) and U2AF1/SF3B1 Splicing Factor mutation (SFm) cohorts 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. FLT3m Cohort ?

12 relapsed/refractory patients enrolled to date: 12 R/R AML patients with FLT3m were treated with emavusertib. Prior therapies included venetoclax (8/12), hypomethylating agents or HMA (9/12), and FLT3 inhibitors (9/12). Preliminary data show 6 objective responses in 11 response-evaluable patients: 3 complete remission (CR), 1 CR with partial hematologic recovery (CRh) and 2 morphologic leukemia-free state (MLFS) with on-treatment duration range of 46-324 days.

4 patients are ongoing at the data-cutoff, including 1 CRh and 1 MLFS. 3 of 3 patients who were naïve to FLT3i treatment achieved objective response (2 CR, 1 MLFS). 3 of 8 patients who progressed on, or following, prior FLT3i treatment achieved objective response (1 CR, 1 CRh, 1 MLFS).

1 patient is not response-evaluable. All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation.

Responses were achieved rapidly in this population, with 5 of 6 responses occurring within one cycle of treatment. SFm Cohort ? 20 relapsed/refractory patients enrolled to date: 20 R/R AML patients with SFm were treated with emavusertib.

Prior therapies included venetoclax (18/20) and HMA (17/20). Preliminary data show 4 of 18 response-evaluable patients in this population have achieved objective response (CR/CRh/MLFS). 8 of 20 patients are ongoing at the data-cutoff, including 1 MLFS and 3 non-responding patients who have shown increased neutrophil counts.

All 4 responders (1 CR, 2 CRh, 1 MLFS) had received prior treatment with an HMA; 3 of whom had also received prior treatment with venetoclax. 3 additional non-responding patients are ongoing and have shown increased neutrophil counts. 2 patients are not response-evaluable.

All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation.