[Translation] Efficacy and safety of QL1207 and Eylea in patients with wet age-related macular degeneration: a randomized, double-blind, parallel, positive-controlled phase III clinical study

主要目的：在湿性年龄相关性黄斑变性（wAMD)患者中，评价玻璃体腔内注射（IVT）QL1207 和艾力雅临床有效性的相似性。次要目的：在 wAMD 患者中,评价 IVTQL1207 和艾力雅临床安全性的相似性;在 60 例受试者中，评价 QL1207 和艾力雅的药代动力学特征。

[Translation]

Primary objective: To evaluate the similarity of clinical efficacy of intravitreal (IVT) QL1207 and Eylea in patients with wet age-related macular degeneration (wAMD). Secondary objective: To evaluate the similarity of clinical safety of IVT QL1207 and Eylea in patients with wAMD; to evaluate the pharmacokinetic characteristics of QL1207 and Eylea in 60 subjects.

Start Date06 Aug 2019

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20182304 / CompletedPhase 1

QL1207和艾力雅在糖尿病性黄斑水肿患者中的安全性、有效性和药代动力学随机双盲阳性药平行对照I期研究

[Translation] A randomized, double-blind, positive-drug, parallel-controlled phase I study of the safety, efficacy, and pharmacokinetics of QL1207 and Eylea in patients with diabetic macular edema

主要目的：在糖尿病性黄斑水肿受试者中，评价玻璃体腔内注射（IVT）QL1207和艾力雅®的安全性。次要目的：在糖尿病性黄斑水肿受试者中，评价IVT QL1207和艾力雅®后的有效性和药代动力学特征。

[Translation]

Primary objective: To evaluate the safety of intravitreal injection (IVT) of QL1207 and Eylea® in subjects with diabetic macular edema. Secondary objective: To evaluate the efficacy and pharmacokinetic characteristics of QL1207 and Eylea® after IVT in subjects with diabetic macular edema.

Start Date14 Feb 2019

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Aflibercept biosimilar(Qilu Pharmaceutical)

100 Translational Medicine associated with Aflibercept biosimilar(Qilu Pharmaceutical)

100 Patents (Medical) associated with Aflibercept biosimilar(Qilu Pharmaceutical)

Literatures (Medical) associated with Aflibercept biosimilar(Qilu Pharmaceutical)

01 Jan 2024·Ophthalmology and Therapy

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

Article

Author: Li, Chaopeng ; Peng, Hui ; Hao, Jilong ; Liang, Xiaoling ; Wu, Miaoqin ; Wu, Zhifeng ; Ke, Min ; Chen, Youxin ; Zhu, Mengli ; Yan, Yang ; Wang, Feng ; Ye, Jian ; Zhao, Mingwei ; Zeng, Siming ; Yu, Fangliang ; Cai, Shanjun ; Li, Suyan ; Pei, Cheng ; Li, Qiuming ; Tang, Luosheng ; Wang, Hui ; Yi, Jinglin ; Zhang, Hong ; Wang, Xian ; Zhou, Zhanyu ; Liu, Lin ; Zhang, Tonghe ; Zheng, Dongping ; Lei, Chunling ; Wang, Jing ; Li, Bing ; Fan, Ke ; Han, Mei ; Wang, Lifei ; Yuan, Huiping ; Song, Yanping ; Wang, Zenghua ; Liu, Xiaoling ; Ren, Qian ; Zhong, Jingxiang

INTRODUCTIONThis 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).METHODSThis 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.RESULTSA 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.CONCLUSIONSQL1207 has equivalent efficacy to aflibercept for nAMD with similar safety profiles. It could be used as an alternative anti-VEGF agent for clinical practice.TRIAL REGISTRATIONClinicalTrials.gov: NCT05345236 (retrospectively registered on April 25, 2022); National Medical Products Administration of China: CTR20190937 (May 20, 2019).

100 Deals associated with Aflibercept biosimilar(Qilu Pharmaceutical)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	DB08885

R&D Status

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Indication	Country/Location	Organization	Date
Diabetic macular oedema	CN	Qilu Pharmaceutical Co., Ltd.	13 Dec 2023
Wet age-related macular degeneration	CN	Qilu Pharmaceutical Co., Ltd.	13 Dec 2023

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