Akeso's Ligufalimab Combination Shows Strong Responses in Frontline AML Trial

Akeso (HKEX: 9926) announced interim Phase II results for its PD-1 antibody, Ligufalimab, combined with venetoclax and azacitidine, demonstrating significant efficacy in newly diagnosed Acute Myeloid Leukemia (AML) patients ineligible for intensive chemotherapy. The combination achieved an overall response rate (ORR) of 93.3% (14/15 patients) and a complete remission (CR) rate of 80% (12/15 patients). Median overall survival (OS) has not yet been reached, with a 12-month OS rate of 72.7%. The single-arm, open-label study also reported a safety profile consistent with known risks of the individual agents. Grade 3 or higher adverse events occurred in 80% of patients, primarily neutropenia (60%), thrombocytopenia (40%), and anemia (33.3%). No new safety signals emerged from the trial data. This data suggests Ligufalimab, which previously showed activity as monotherapy in relapsed/refractory AML, could offer a significant treatment advancement for frontline AML patients, where the current standard of care is venetoclax plus azacitidine.