#Hong Kong #AML #Akeso #Ligufalimab

Promising Phase II Data on Ligufalimab for AML

Akeso, Inc. recently shared noteworthy findings from its Phase II trial involving ligufalimab, an innovative anti-CD47 monoclonal antibody. The trial's results will be highlighted during an oral presentation at the Europe Hematology Association (EHA) Congress 2026. Ligufalimab's efficacy as a combination therapy was assessed in patients with treatment-naïve Acute Myeloid Leukemia (AML) who were ineligible for conventional intensive chemotherapy. The combination of ligufalimab with azacitidine (AZA) and venetoclax (VEN) has shown exceptional results regarding patient survival and safety.

Study Insights and Results

As of the data cutoff in November 2025, the trial revealed impressive metrics in terms of treatment response. The objective response rate (ORR) reached 80% for the ligufalimab group, compared to 66.7% for the control group. Moreover, the composite complete remission (CRc) rate indicated significant responses: 56.7% in the ligufalimab arm versus 53.3% in the control arm.

Among patients who achieved CRc, the measurable residual disease (MRD) negativity rate of 46.7% was prominently higher compared to 36.7% among controls. Notably, the median duration of CRc stood at a remarkable 10.4 months for ligufalimab compared to 6.5 months for the control group, indicating a substantial lead in treatment longevity.

Survival Advantages

The trial also focused on survival benefits from the ligufalimab treatment. With a median follow-up duration of 8.84 months, the median overall survival (mOS) for the ligufalimab arm was not yet reached, whereas it was recorded at 8.3 months for the control group. This led to notable statistics, with a 9-month overall survival rate of 78.7% reported for the ligufalimab group against just 43.1% for the control group. Similarly, the 6-month overall survival rates favored ligufalimab at 83.3%, compared to 73.2% for the control.

Safety Evaluation

In conjunction with efficacy, the safety profile for ligufalimab appeared favorable, showing no new safety signals amidst its administration. The incidence of treatment-emergent adverse events (TEAEs) was comparable across both groups, underscoring the stability of the treatment. The common adverse events were consistent with the profiles seen in AML and therapies involving AZA + VEN. Notably, anemia rates stood at 46.7% for the ligufalimab arm versus 50% in the control arm, which indicates relatively manageable side effects.

Future Implications and Development

With the Orphan Drug Designation (ODD) already granted by the U.S. FDA for ligufalimab's use in AML, Akeso is poised to advance its clinical programs for ligufalimab on a global scale. This trial marks a significant step not just for hematologic malignancies but also extends into solid tumors, making ligufalimab the first of its kind anti-CD47 monoclonal antibody to begin its Phase III clinical trials in the solid tumor space.

About Akeso, Inc.

Established in 2012, Akeso, Inc. is focused on the development of pioneering biopharmaceutical solutions. Utilizing advanced platforms for drug discovery, the company aims to deliver first-in-class medications across various therapeutic areas, including cancer, autoimmune diseases, and more. Akeso's comprehensive approach is highlighted through a diverse pipeline of over 50 innovative assets, with 27 candidates currently in clinical trials and 7 being commercially available. The firm's commitment to research and development underscores its goal to revolutionize the biopharmaceutical landscape while addressing significant health challenges worldwide.

Conclusion

The Phase II trial results of ligufalimab in patients with AML represent a monumental advancement in oncology treatment options. The strong efficacy, coupled with an acceptable safety profile, illustrates the potential for improved outcomes in a challenging patient population. With continued development, ligufalimab holds promise for redefining AML therapies, offering hope where traditional methods fell short.