Akeso's Ligufalimab Combination Therapy Shows Survival Benefit in Frontline AML
Event summary
- Akeso's Phase II trial of ligufalimab in combination with azacitidine and venetoclax showed a median event-free survival of 9.1 months vs. 6.9 months in the control group.
- Median overall survival was not reached in the ligufalimab group vs. 8.3 months in the control group.
- Objective response rate was 80.0% in the ligufalimab group vs. 66.7% in the control group.
- Ligufalimab has received Orphan Drug Designation from the U.S. FDA for AML treatment.
- Akeso is advancing ligufalimab's clinical development across hematologic malignancies and solid tumors.
The big picture
Akeso's positive Phase II results for ligufalimab in frontline AML position the company competitively in the hematologic malignancies space. The survival benefits observed could make ligufalimab a key player in treating AML patients ineligible for intensive chemotherapy. Akeso's rapid advancement of ligufalimab into solid tumor trials also highlights its ambition to become a leader in both hematologic and solid tumor therapies.
What we're watching
- Regulatory Pathway
- Whether the Phase II results will accelerate ligufalimab's path to regulatory approval in AML.
- Clinical Development
- The pace at which Akeso advances ligufalimab into Phase III trials for solid tumors.
- Competitive Positioning
- How Akeso differentiates ligufalimab in the crowded anti-CD47 space.
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