lThe journal eClinicalMedicine, part of THE LANCET Discovery Science, has released a phase III clinical trial result on pegmolesatide for anemia patients on dialysis with chronic kidney disease (CKD)1.
lTo further investigate whether pegmolesatide offers additional benefits to CKD patients with anemia on dialysis, researchers conducted a post-hoc analysis of the aforementioned phase III study.
lThe post-hoc analysis results, released at the 2024 ASN annual meeting, confirmed that pegmolesatide injection is capable of achieving the goals of maintaining hemoglobin level more effectively than short-acting erythropoietins (EPOs), and is superior in terms of safety.
The 2024 American Society of Nephrology (ASN) Kidney Week conference was held at the San Diego Convention Center in the United States from October 23 to 27 local time. The post-hoc analysis results of the phase III study of Hansoh Pharma's self-developed Class 1 innovative drug, pegmolesatide (trade name: Saint Luolai) for treating anemia in patients with chronic kidney disease (CKD) on dialysis, were presented as poster form at the conference2.
The ASN Annual Meeting is the premier global nephrology conference, aiming to share and discuss the latest research advancements and cutting-edge topics in the field of kidney diseases. In 2024, the conference attracted more than 12,000 professionals from the renal field around the world3.
Pegmolesatide is a novel long-acting pegylated (PEG) erythropoietin mimetic peptide, approved by the National Medical Products Administration (NMPA) in June 2023 for the treatment of anemia caused by chronic kidney disease (CKD)4, and was included in the National Reimbursement Drug List (NRDL) of China in the same year.
A randomized, multicenter, open-label, non-inferiority phase Ⅲ trial of pegmolesatide for anemia in CKD dialysis patients was previously published in eClinicalMedicine，which confirmed the efficacy and safety of pegmolesatide in treating anemia in CKD dialysis patients，with patients achieving stable hemoglobin targets with just one subcutaneous injection per month.
The Phase III post-hoc analysis results of pegmolesatide treatment for anemia in CKD patients undergoing hemodialysis, released at this ASN annual meeting, further confirm that pegmolesatide is superior in maintaining hemoglobin target level compared to short-acting erythropoietins, with an improved safety profile. The detailed information is as follows:
Study Profile
Pegmolesatide for the Treatment of Anemia in Patients with CKD Undergoing Dialysis: Insights from a Randomized Active-Controlled Phase 3 Study
lOctober 24, 2024 | Location: Exhibit Hall, Convention Center
lAbstract Time: 10:00 AM - 12:00 PM
lCategory: Anemia and Iron Metabolism
l200 Anemia and Iron Metabolism
Authors
lChen, Jianghua, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
lZhou, Linghui, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
lGuo, Minghao, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
lZheng, Hongguang, General Hospital of Northern Theater Command, Shenyang, Liaoning, China
lXie, Deqiong, Second People's Hospital of Yibin, Yibin, Sichuan, China
lHu, Zhizhen, Jiangsu Hansoh Pharmaceutical Co Ltd, Lianyungang, Jiangsu, China
lLuo, Weili, Jiangsu Hansoh Pharmaceutical Co Ltd, Lianyungang, Jiangsu, China
BACKGROUND
Pegmolesatide, a novel long-acting pegylated erythropoietin mimetic peptide, has proved comparable efficacy and safety with epoetin alfa based on a randomized, multicenter, open-label, non-inferiority phase 3 study (NCT03902691). This post-hoc analysis aims to explore further benefits of pegmolesatide for the treatment of anemia patients on dialysis.
METHODS
A total of 372 chronic kidney disease (CKD) patients undergoing dialysis were randomized (2:1) to receive pegmolesatide or epoetin alfa for 52 weeks. Post-hoc analysis was conducted to assess the proportions of patients across various hemoglobin (Hb) ranges during the efficacy evaluation period.
RESULTS
A larger proportion of patients on pegmolesatide achieved mean Hb≥11 g/dL compared to those on epoetin alfa (63.9% vs. 44.7%, P=0.0003). More patients receiving pegmolesatide maintained their Hb levels within the target ranges of 11-12 g/dL (35.2% vs. 22.8%, P=0.0164) and 11-13 g/dL (57.5% vs. 36.8%, P=0.0002) compared to those receiving epoetin alfa. In subgroups of baseline characteristics with age ≤65 yrs., primary hypertension, stage 5 CKD≥12 months, CRP≤11.5 mg/L, serum ferritin between 100-500 ng/mL, and transferrin saturation≥20%, pegmolesatide also showed greater effect in maintaining Hb levels between 11-12 g/dL (Figure). Similar findings were observed in these subgroups for the target range of 11-13 g/dL. The incidences of treatment related adverse events of particular interest, including hypertension (4.5% vs. 6.5%), hepatotoxicity (0.8% vs. 2.4%) and hyperkalaemia (2.4% vs. 4.0%), were numerically lower in the pegmolesatide group.
CONCLUSION
Pegmolesatide demonstrated a stronger likelihood of maintaining Hb levels within guideline-recommended ranges and potentially provided a more favorable safety profile compared to epoetin alfa.
Reference:
【1】Zhang P, et al. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial. EClinicalMedicine. 2023 Oct 28;65:102273.
【2】Chen Jianghua,et al.Pegmolesatide for the Treatment of Anemia in Patients with CKD Undergoing Dialysis: Insights from a Randomized Active-Controlled Phase 3 Study. ASN 2024. ABSTRACT: TH-PO888
【3】American Society of Nephrology （ASN）.
【4】国家药监局批准培莫沙肽注射液上市. https://www.nmpa.gov.cn/yaowen/ypjgyw/ypyw/20230630195113151.html（发布时间：2023-06-30）
