Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial.

Aflibercept Biosimilar Neovascular age-related macular degeneration QL1207

Journal

Ophthalmology and therapy
ISSN: 2193-8245
Titre abrégé: Ophthalmol Ther
Pays: England
ID NLM: 101634502

Informations de publication

Date de publication:
21 Nov 2023
Historique:
received: 14 06 2023
accepted: 11 10 2023
medline: 21 11 2023
pubmed: 21 11 2023
entrez: 21 11 2023
Statut: aheadofprint

Résumé

This trial aimed to compare the efficacy and safety between biosimilar QL1207 and the reference aflibercept for the treatment of neovascular age-related macular degeneration (nAMD). This randomized, double-blind, phase 3 trial was conducted at 35 centers in China. Patients aged ≥ 50 years old with untreated subfoveal choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) letter score of 73-34 were eligible. Patients were randomly assigned to receive intravitreous injections of QL1207 or aflibercept 2 mg (0.05 ml) in the study eye every 4 weeks for the first 3 months, followed by 2 mg every 8 weeks until week 48, stratified by baseline BCVA ≥ or < 45 letters. The primary endpoint was BCVA change from baseline at week 12. The equivalence margin was ± 5 letters. The safety, immunogenicity, pharmacokinetics (PK), and plasma vascular endothelial growth factor (VEGF) concentration were also evaluated. A total of 366 patients were enrolled (QL1207 group, n = 185; aflibercept group, n = 181) from Aug 2019 to Jan 2022 with comparable baseline characteristics. The least-squares mean difference in BCVA changes was - 1.1 letters (95% confidence interval - 3.0 to 0.7; P = 0.2275) between the two groups, within the equivalence margin. The incidences of treatment-emergent adverse events (TEAE; QL1207: 71.4% [132/185] vs. aflibercept: 71.8% [130/181]) and serious TEAE (QL1207: 14.1% [26] vs. aflibercept: 12.7% [23]) appeared comparable between treatment groups, and no new safety signal was found. Anti-drug antibody, PK profiles, and VEGF concentration were similar between the two groups. QL1207 has equivalent efficacy to aflibercept for nAMD with similar safety profiles. It could be used as an alternative anti-VEGF agent for clinical practice. ClinicalTrials.gov: NCT05345236 (retrospectively registered on April 25, 2022); National Medical Products Administration of China: CTR20190937 (May 20, 2019).

Identifiants

DOI: 10.1007/s40123-023-00836-4 PMID: 37987893
pubmed: 37987893
doi: 10.1007/s40123-023-00836-4
pii: 10.1007/s40123-023-00836-4
doi:

Banques de données

ClinicalTrials.gov
['NCT05345236']

Types de publication

Journal Article

Langues

eng

Informations de copyright

© 2023. The Author(s).

Références

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Auteurs

Bing Li (B)

Ophthalmology Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China.

Ke Fan (K)

Ophthalmology Department, Henan Provincial Eye Hospital, Zhengzhou, China.

Tonghe Zhang (T)

Ophthalmology Department, Jinan Second People's Hospital, Jinan, China.

Zhifeng Wu (Z)

Ophthalmology Department, Wuxi Second People's Hospital, Wuxi, China.

Siming Zeng (S)

Ophthalmology Department, Guangxi Zhuang Autonomous Region People's Hospital, Nanning, China.

Mingwei Zhao (M)

Ophthalmology Department, Peking University People's Hospital, Beijing, China.

Qian Ren (Q)

Ophthalmology Department, Shijiazhuang People's Hospital, Shijiazhuang, China.

Dongping Zheng (D)

Ophthalmology Department, Shanxi Ophthalmic Hospital, Taiyuan, China.

Lifei Wang (L)

Ophthalmology Department, Hebei Eye Hospital, Xingtai, China.

Xiaoling Liu (X)

Ophthalmology Department, Eye Hospital, WMU Zhejiang Eye Hospital, Wenzhou, China.

Mei Han (M)

Ophthalmology Department, Tianjin Eye Hospital, Tianjin, China.

Yanping Song (Y)

Ophthalmology Department, General Hospital of Central Theater Command, Wuhan, China.

Jian Ye (J)

Ophthalmology Department, Army Medical Center of PLA, Chongqing, China.

Cheng Pei (C)

Ophthalmology Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.

Jinglin Yi (J)

Ophthalmology Department, Affiliated Eye Hospital of Nanchang University, Nanchang, China.

Xian Wang (X)

Ophthalmology Department, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.

Hui Peng (H)

Ophthalmology Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

Hong Zhang (H)

Ophthalmology Department, The First Affiliated Hospital of Harbin Medical University, Harbin, China.

Zhanyu Zhou (Z)

Ophthalmology Department, Qingdao Municipal Hospital, Qingdao, China.

Xiaoling Liang (X)

Ophthalmology Department, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.

Fangliang Yu (F)

Ophthalmology Department, The First Hospital of Nanchang, Nanchang, China.

Miaoqin Wu (M)

Ophthalmology Department, Zhejiang Provincial People's Hospital, Hangzhou, China.

Chaopeng Li (C)

Ophthalmology Department, Huai'an First People's Hospital, Huai'an, China.

Chunling Lei (C)

Ophthalmology Department, Xi'an People's Hospital, Xi'an, China.

Jilong Hao (J)

Ophthalmology Department, First Hospital of Jilin University, Changchun, China.

Luosheng Tang (L)

Ophthalmology Department, The Second Xiangya Hospital of Center South University, Changsha, China.

Huiping Yuan (H)

Ophthalmology Department, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.

Shanjun Cai (S)

Ophthalmology Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.

Qiuming Li (Q)

Ophthalmology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.

Jingxiang Zhong (J)

Ophthalmology Department, The First Affiliated Hospital of Jinan University, Guangzhou, China.

Suyan Li (S)

Ophthalmology Department, Xuzhou First People's Hospital, Xuzhou, China.

Lin Liu (L)

Ophthalmology Department, Renji Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China.

Min Ke (M)

Ophthalmology Department, Wuhan University Zhongnan Hospital, Wuhan, China.

Jing Wang (J)

Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.

Hui Wang (H)

Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.

Mengli Zhu (M)

Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.
ORCID: 0009-0007-3840-8799

Zenghua Wang (Z)

Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.

Yang Yan (Y)

Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China.

Feng Wang (F)

Ophthalmology Department, The Second Affiliated Hospital of Xi'an Jiaotong University, No. 157, Xiwu Road, Xincheng District, Xi'an, 710004, China. wfoculist@126.com.

Youxin Chen (Y)

Ophthalmology Department, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 100730, China. chenyx@pumch.cn.

Classifications MeSH