Curis Reports 62.5% Undetectable MRD Rate in AML Triplet Therapy Study at ASH 2025
核心洞察
Curis (搜索) reported updated data from its frontline AML triplet study showing 5 of 8 patients (62.5%) achieved undetectable minimal residual disease (uMRD) as of October 2025.
The study evaluates emavusertib added to venetoclax and azacitidine in AML patients who achieved complete remission but remained MRD-positive.
Results showed improvement from initial data reported in July 2025, when 4 of 8 patients (50%) had achieved uMRD.
Curis (搜索) Inc. presented updated clinical data from its ongoing frontline acute myeloid leukemia (AML) triplet study at the 67th ASH Annual Meeting, showing that 5 of 8 patients (62.5%) achieved undetectable minimal residual disease (uMRD) as of October 12, 2025. The results represent an improvement from initial data reported in July 2025, when 4 of 8 patients (50%) had achieved uMRD.
Study Design and Patient Population
The AML triplet study (CA-4948-104) is evaluating the addition of emavusertib (ema) to the combination of venetoclax and azacitidine (ven-aza) in AML patients who have achieved complete remission on ven-aza but remain MRD-positive (MRD+). The study aims to enable patients to achieve uMRD through this triplet combination approach.
The first two cohorts in the study evaluate patients who received emavusertib for either 7 or 14 days in a 28-day cycle, in addition to their ven-aza treatment regimen. Emavusertib is an orally available, small molecule IRAK4 (搜索) and FLT3 (搜索) inhibitor being developed by the biotechnology company.
Safety Profile Maintained
According to the company's presentation, the updated efficacy results showed no change in safety profile compared to the initial data reported in July. The study continues to evaluate the optimal dose and schedule for the triplet combination to maximize both safety and efficacy outcomes.
Clinical Significance
"These data are very promising and warrant further evaluation of additional triplet (ema/ven/aza) regimens to determine the optimal dose and schedule for safety and efficacy to improve patient outcomes in a difficult to treat population," said James Dentzer, Curis (搜索)'s Chief Executive Officer.
The study addresses an important clinical need in AML patients who achieve complete remission with standard venetoclax and azacitidine therapy but remain at risk due to persistent minimal residual disease. Achieving undetectable MRD status is considered a critical therapeutic goal that may translate to improved long-term outcomes.
Broader Development Program
Emavusertib is currently being evaluated across multiple clinical studies, including the TakeAim Lymphoma Phase 1/2 study in combination with ibrutinib for relapsed/refractory primary central nervous system lymphoma, and the TakeAim Leukemia Phase 1/2 study as monotherapy in patients with relapsed/refractory AML and high-risk myelodysplastic syndrome.
The drug candidate has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of primary central nervous system lymphoma, AML, and myelodysplastic syndrome, as well as from the European Commission for primary central nervous system lymphoma treatment.