On May 14, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported updated data from the ongoing TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) AML to be presented at the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences (Press release, Curis, MAY 14, 2024, View Source [SID1234643214]).

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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.

Prior

Data

New
Data*

Total

FLT3m AML

3

9

12

SFm AML

3

17

20

adjustment for patients with dual mutation**

(1)

(1)

(2)

5

25

30

* data cut-off as of February 26, 2024
** 2 patients had both FLT3m and SFm (dual mutation)
1 patient in the initial group of 5 patients; 1 patient in the new group of 25 additional patients

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. "In addition to the responders, we see increased neutrophil counts in several additional ongoing patients. Since a leading cause of death in patients with AML is infection (related to low neutrophil counts), an increase in neutrophils represents a meaningful clinical improvement for these patients," said Dr. Robert Martell, MD, PhD, Chief Scientific Officer of Curis.

"We are encouraged by emavusertib’s continued demonstration of clear single-agent activity supporting its potential in both monotherapy and combination therapy in AML," said James Dentzer, President and CEO of Curis.