HONG KONG, May 15, 2026
Akeso, Inc. announced positive Phase II clinical trial results for ligufalimab (AK117) in frontline acute myeloid leukemia (AML) patients during the European Hematology Association Congress 2026. The randomized, double-blind, placebo-controlled study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in treatment-naïve AML patients who were ineligible for intensive chemotherapy. The company reported encouraging efficacy, prolonged remission duration, improved survival trends, and a manageable safety profile, reinforcing the growing clinical potential of anti-CD47 therapies in hematologic cancers.
Ligufalimab is Akeso’s proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody, designed to enhance anti-tumor immune responses while minimizing toxicity concerns associated with earlier CD47-targeting approaches. The newly released data from the AK117-206 Phase II trial demonstrated that the triplet therapy achieved higher response rates and more durable remissions compared to standard AZA plus VEN therapy alone. Researchers believe the combination may provide a more effective frontline treatment option for older AML patients and those unable to tolerate aggressive chemotherapy regimens.
Ligufalimab Combination Shows Strong Remission and Survival Results
According to the trial data cutoff from November 2025, the ligufalimab treatment arm achieved an objective response rate (ORR) of 80%, compared to 66.7% in the control group. The composite complete remission (CRc) rate reached 56.7% in the ligufalimab arm versus 53.3% in patients receiving standard treatment alone. Importantly, measurable residual disease (MRD) negativity rates were also higher in patients treated with ligufalimab, indicating deeper remission responses that could translate into improved long-term outcomes.
The study further demonstrated meaningful improvements in remission durability and survival trends. Patients treated with ligufalimab achieved a median CRc duration of 10.4 months, significantly longer than the 6.5 months observed in the control arm. At a median follow-up of 8.84 months, median overall survival (mOS) had not yet been reached in the ligufalimab group, while the control group reported a median survival of 8.3 months. The 9-month overall survival rate reached 78.7% in the ligufalimab arm compared with 43.1% in the control group, suggesting a potentially meaningful survival advantage.
Safety Profile Supports Further Clinical Development
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Researchers reported that ligufalimab demonstrated a manageable safety profile with no unexpected toxicities or new safety signals identified during the study. The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events remained generally comparable between the treatment and control groups. Common adverse events were consistent with expectations for AML patients receiving AZA and VEN-based therapies.
Notably, anemia rates were slightly lower in the ligufalimab treatment arm, occurring in 46.7% of patients compared to 50% in the control group. These findings are considered important because safety and tolerability remain major concerns when combining immunotherapy agents with existing AML treatment regimens, especially in elderly or medically fragile patients.
The encouraging clinical data strengthen Akeso’s position in the rapidly evolving anti-CD47 therapeutic landscape, where multiple companies are competing to develop safer and more effective macrophage checkpoint inhibitors. Ligufalimab has already received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration for AML treatment, highlighting the unmet medical need in relapsed and frontline AML populations.
Akeso Expands Global Oncology Pipeline
Akeso continues advancing ligufalimab across multiple hematologic malignancies and solid tumor programs globally. The company noted that ligufalimab is currently the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors, positioning Akeso among the leading innovators in next-generation immuno-oncology.
Founded in 2012, Akeso has developed a broad pipeline of more than 50 innovative therapeutic assets spanning oncology, autoimmune diseases, inflammation, metabolic disorders, and cell therapies. The company’s drug discovery platforms include Tetrabody antibody technology, AI-powered drug development systems, bispecific antibodies, ADC technologies, T-cell engagers, and RNA-based therapies. Industry analysts view Akeso’s expanding clinical portfolio as a significant driver of growth within the global biopharmaceutical sector.
Source: Akeso press release
