Akeso is spotlighting positive Phase II data for its anti-CD47 monoclonal antibody ligufalimab (AK117) in acute myeloid leukemia, ahead of its oral presentation at the 2026 European Hematology Association (EHA) Congress.
The randomized, double‑blind, placebo‑controlled AK117‑206 trial tested ligufalimab plus azacitidine and venetoclax versus placebo plus azacitidine and venetoclax in previously untreated AML patients ineligible for intensive chemotherapy, with data cut in November 2025.
Akeso reports an 80.0% objective response rate (ORR) and 56.7% composite complete remission (CRc) rate in the ligufalimab arm versus 66.7% and 53.3% in the control arm, with higher MRD‑negative CRc and longer median CRc duration (10.4 vs 6.5 months).
At a median follow‑up of 8.84 months, median overall survival was not reached in the ligufalimab arm versus 8.3 months in the control group, with a 9‑month overall survival rate of 78.7% vs 43.1% and a 6‑month OS of 83.3% vs 73.2%.
The ligufalimab combination showed a manageable safety profile, with treatment‑emergent adverse events and serious adverse events generally aligned with AML and azacitidine–venetoclax therapy, and anemia rates of 46.7% with ligufalimab versus 50.0% in the control arm.
Sources:
Phase II Data from a Randomized Double-Blind Trial of Ligufalimab ...
Akeso's ligufalimab shows 80% response in AML - AllSci
[PDF] A Phase 1b Study Evaluating the Safety and Efficacy of AK117 (anti ...
Phase II Data from a Randomized Double-Blind Trial of Ligufalimab ...