Abstract: FR-PO0199
Efficacy and Cardiovascular Safety of Pegmolesatide in Renal Anemia: Post Hoc Analysis of Two Phase 3 Trials
Session Information
- Anemia and Iron Metabolism
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Chen, Jianghua, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
- Yu, Xueqing, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
- Hu, Zhizhen, Hansoh Pharmaceutical Group Co Ltd, Lianyungang, Jiangsu, China
- Luo, Weili, Hansoh Pharmaceutical Group Co Ltd, Lianyungang, Jiangsu, China
- Cheng, Xue, Hansoh Pharmaceutical Group Co Ltd, Lianyungang, Jiangsu, China
- Li, Ping, Hansoh Pharmaceutical Group Co Ltd, Lianyungang, Jiangsu, China
- Xiao, Yongzhen, Hansoh Pharmaceutical Group Co Ltd, Lianyungang, Jiangsu, China
Background
Pegmolesatide selectively binds erythropoietin receptor with higher affinity than erythropoietin, suggesting cardiovascular (CV) benefits. Here we further evaluated its efficacy and CV safety in dialysis-dependent (DD) and non-dialysis-dependent (NDD) chronic kidney disease (CKD) patients.
Methods
Post hoc analysis was conducted on data from two multicenter, open-label, phase 3 non-inferiority trials (NCT03902691, NCT03903809). 547 patients (372 DD-CKD; 175 NDD-CKD) were randomized 2:1 to receive pegmolesatide (every four weeks) or epoetin alfa for 52 weeks. Hemoglobin (Hb) response rates (mean Hb ≥ 10 g/dL during the efficacy evaluation period) were analyzed. CV safety included 5-point major adverse CV events (5P MACE; CV death, myocardial infarction, stroke, unstable angina and heart failure requiring hospitalization) and expanded CV events.
Results
In the per-protocol set population, pegmolesatide showed numerically higher Hb response rates (≥ 10 g/dL) versus epoetin alfa in both DD-CKD (91.8% vs. 88.6%) and NDD-CKD (87.0% vs. 85.4%) patients. The incidences of 5P MACE (DD-CKD: 2.0% vs. 5.6%, HR 0.35, 95%CI 0.11-1.10; NDD-CKD: 0.9% vs. 6.9%, HR 0.14, 95%CI 0.02-1.28; Table; Figure) and expanded CV events (DD-CKD: 6.9% vs. 10.5%, HR 0.64, 95%CI 0.31-1.32; NDD-CKD: 5.2% vs. 10.3%, HR 0.57, 95%CI 0.18-1.75) were consistently lower in the pegmolesatide group across both patient populations.
Conclusion
Pegmolesatide demonstrates effectiveness in Hb management for both NDD-CKD and DD-CKD populations, with potential benefits in reducing the risk of CV events compared to epoetin alfa.
Funding
- Commercial Support – Hansoh Pharmaceutical Group Co, Ltd