On June 17, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) were presented as an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress. Ligufalimab is Akeso’s proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody. The study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
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Ligufalimab-based combination therapy demonstrates a significant trend toward survival benefit
At a median follow-up of 10 months in the ligufalimab group and 8.8 months in the control group, median event-free survival (EFS) was 9.1 months in the ligufalimab group versus 6.9 months in the control group (hazard ratio [HR] = 0.46). The 6-month EFS rate was 67.8% versus 55.5% in the control group, and the 9-month EFS rate was 53.2% versus 14.1%.
Median overall survival (mOS) was not reached in the ligufalimab group versus 8.3 months in the control group (HR = 0.46). The 6-month OS rate was 83.3% versus 73.2%, and the 9-month OS rate was 78.7% versus 43.1% in the control group.
Ligufalimab-based combination therapy yields deep tumor responses
The objective response rate (ORR) was 80.0% in the ligufalimab group versus 66.7% in the control group, and the composite complete response (CRc) rate was 56.7% versus 53.3%; the proportion of patients achieving CRc with minimal residual disease (MRD) negativity was higher in the ligufalimab group than in the control group (46.7% vs. 36.7%).
The median duration of CRc was 10.4 months in the ligufalimab group, which was markedly superior to 5.6 months in the control group.
Favorable Safety Profile With No New Safety Signals Observed
The incidence of overall treatment-emergent adverse events (TEAEs) and serious adverse events was comparable between treatment arms. The most common TEAEs were generally consistent with those expected in the context of AML and AZA+VEN therapy.
Anemia occurred in 46.7% of patients in the ligufalimab arm versus 50.0% in the control arm.
Notably, ligufalimab has already received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of AML. Akeso is advancing its ligufalimab clinical development programs at a globally competitive pace across both hematologic malignancies and solid tumors. Ligufalimab is also the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors.
(Press release, Akeso Biopharma, JUN 17, 2026, View Source [SID1234668786])