A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.
Newly diagnosed higher-risk MDS.
ECOG score of ≤2.
Expected survival ≥ 3 months.
Adequate organ function.
Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
Have undergone hematopoietic stem cell transplantation.
Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
MDS or other conditions that cannot be administered enterally.
Parallel
Lisaftoclax (APG-2575)
DrugQD, oral administration.
Azacitidine Injection
DrugQD, hypodermic or intravenous injection.
Placebo
Other interventionQD, oral administration.
Overall Survival（OS）
The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.
Safety evaluation based on the adverse event concurrence
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
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