Akeso, Inc. announced that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) will be presented as an oral presentation at the 2026 European Hematology Association (EHA) Congress. The abstract is now available on the EHA Congress platform.

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.

The abstract data demonstrated that the ligufalimab-based triplet regimen delivered encouraging efficacy, with significant improvements in survival outcomes. The combination also showed a manageable safety profile, offering a potentially better-tolerated treatment option for this vulnerable patient population.

As of the November 2025 data cutoff, key findings included:

Deep and Durable Tumor Remission

• The objective response rate (ORR) was 80.0% in the ligufalimab arm versus 66.7% in the control arm, with a composite complete remission (CRc) rate of 56.7% versus 53.3%. Among patients achieving CRc, the measurable residual disease (MRD) negativity rate was higher in the ligufalimab arm (46.7% versus 36.7%).
• Median duration of CRc was substantially longer in the ligufalimab arm at 10.4 months versus 6.5 months in the control arm.

Encouraging Survival Benefit Trend

• At a median follow-up of 8.84 months, median overall survival (mOS) in the ligufalimab arm was not yet reached, versus 8.3 months in the control arm. The 9-month overall survival rate was 78.7% in the ligufalimab arm versus 43.1% in the control arm; the 6-month OS rates were 83.3% versus 73.2%, respectively.

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.