Akeso’s Ligufalimab Shows Survival Gains in Phase II AML Trial

The study tracked patients ineligible for intensive chemotherapy, comparing the ligufalimab regimen against a control group. Data revealed a median event-free survival of 9.1 months for those receiving the antibody, compared to 6.9 months in the control arm, yielding a hazard ratio of 0.46. While the median overall survival for the ligufalimab group had not been reached at the time of reporting, the control group recorded a median of 8.3 months.

Beyond survival metrics, the drug showed efficacy in achieving deep tumor responses. The objective response rate reached 80% in the experimental arm, with 46.7% of patients achieving minimal residual disease negativity—a key marker of treatment depth. The clinical team noted that the duration of composite complete responses was 10.4 months with ligufalimab, nearly doubling the 5.6-month duration observed in the control group.

Safety data indicated that the addition of ligufalimab did not introduce new adverse signals. The incidence of serious treatment-emergent events remained comparable between the two arms, with anemia rates aligning with expectations for current azacitidine and venetoclax protocols. Given these results, the U.S. FDA has already granted ligufalimab Orphan Drug Designation, bolstering Akeso’s strategy to position the candidate as a front-line intervention for hematologic malignancies.