Ying Cheng, Zhanyu Pan, Lin Wu, Bo Zhu, Yan Yu, Kai Zang, Wu Zhuang, Lianke Liu, Kangsheng Gu, Juanwen Lian, Rixin Chen, Tao Bian, Dang Lin, Shenghua Sun, Wei Li, Xiaosheng Hang, Ou Jiang, Fukuan Zhong, Rui Wang, Hui Luo, Huaqiu Shi, Zonghui Wei, Li Zhao, Shaoshui Chen, Hongmei Sun, Xingya Li, Debin Sun, Tiejun Ren, Kaijian Lei, Miao He, Gaofeng Li, Hailong Liu, Runpu Li, Chunhong Hu, Li Kong, Meili Sun, Liangzhi Xie, Wenlin Gai, Weiqiu Chen, Zhe Huang, Wenwen Ren, Huo Su
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In this study, we aimed to demonstrate the equivalence of SCT510 and bevacizumab in terms of efficacy, safety, immunogenicity and pharmacokinetics (PK) in patients with advanced non-squamous non-small cell lung cancer (NSCLC).</p><h3>Methods</h3><p>Patients with non-squamous NSCLC were randomized equally to the SCT510 group (comprising SCT510, paclitaxel, and carboplatin) and the bevacizumab group (comprising bevacizumab, paclitaxel, and carboplatin) for 4–6 cycles, followed by maintenance monotherapy with SCT510. The primary endpoint was the objective response rate (ORR) at week 12. 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引用次数: 0
摘要
简介SCT510 是贝伐珠单抗（安维汀）的生物类似药，已被批准用于多种转移性癌症。在这项研究中，我们旨在证明 SCT510 和贝伐珠单抗在晚期非鳞状非小细胞肺癌（NSCLC）患者中的疗效、安全性、免疫原性和药代动力学（PK）方面的等效性：将非鳞状NSCLC患者随机平均分为SCT510组（包括SCT510、紫杉醇和卡铂）和贝伐珠单抗组（包括贝伐珠单抗、紫杉醇和卡铂），各治疗4-6个周期，然后用SCT510维持单药治疗。主要终点是第12周的客观反应率（ORR）。次要终点包括18周ORR、疾病控制率（DCR）、反应持续时间（DoR）、无进展生存期（PFS）、总生存期（OS）和1年生存率，以及安全性、免疫原性和多剂量PK分析评估：2019年3月29日至2021年4月27日期间，共筛选出989名患者，567名符合条件的患者被随机分配到SCT510组（285名患者）和贝伐珠单抗组（282名患者）。第12周时，SCT510组的ORR为52.6%[95%置信区间（CI）46.66-58.55%]，贝伐单抗组为52.5%（95% CI 46.47-58.47%）。第18周时，SCT510的ORR为55.4%（95% CI 49.46-61.30%），贝伐珠单抗为55.7%（95% CI 49.68-61.62%）。第12周和第18周的ORR风险比（RR）分别为0.99（90% CI 0.873-1.133）和0.99（90% CI 0.872-1.114），均在预先指定的0.75-1.33等效范围内。两组在其他次要终点，特别是DCR、DOR、PFS、OS和1年生存率方面没有差异。两组治疗的总体安全性结果相似，SCT510和贝伐珠单抗RP都表现出较低的免疫原性：结论：在晚期非鳞癌NSCLC患者中，SCT510与贝伐珠单抗在临床疗效、安全性、免疫原性和PK方面相似。所有证据都支持SCT510与贝伐珠单抗具有临床等效性：试验注册：NCT03792074。
Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study
Introduction
SCT510 is a biosimilar to bevacizumab (Avastin) reference product (RP) that is approved for various metastatic cancers. In this study, we aimed to demonstrate the equivalence of SCT510 and bevacizumab in terms of efficacy, safety, immunogenicity and pharmacokinetics (PK) in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
Methods
Patients with non-squamous NSCLC were randomized equally to the SCT510 group (comprising SCT510, paclitaxel, and carboplatin) and the bevacizumab group (comprising bevacizumab, paclitaxel, and carboplatin) for 4–6 cycles, followed by maintenance monotherapy with SCT510. The primary endpoint was the objective response rate (ORR) at week 12. Secondary endpoints included 18-week ORR, disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and 1-year survival rate, as well as assessments of safety, immunogenicity, and multi-dose PK analysis.
Results
Between March 29, 2019, and April 27, 2021, 989 patients were screened and 567 eligible patients were randomly assigned to the SCT510 group (285 patients) and the bevacizumab group (282 patients). The ORR at week 12 was 52.6% [95% confidence interval (CI) 46.66–58.55%] in the SCT510 group and 52.5% (95% CI 46.47–58.47%) in the bevacizumab group. The ORR at week 18 was 55.4% (95% CI 49.46–61.30%) for SCT510 and 55.7% (95% CI 49.68–61.62%) for bevacizumab. The ORR risk ratio (RR) at weeks 12 and 18 was 0.99 (90% CI 0.873–1.133) and 0.99 (90% CI 0.872–1.114), respectively, both within the pre-specified equivalence margin of 0.75–1.33. There were no differences between the two groups in relation to other secondary endpoints, specifically DCR, DOR, PFS, OS, and 1-year survival rate. The overall safety findings were similar between the two treatment groups, and both SCT510 and bevacizumab RP exhibited low immunogenicity.
Conclusions
SCT510 is similar to bevacizumab in clinical efficacy, safety, immunogenicity, and PK in patients with advanced non-squamous NSCLC. The totality of the evidence supports the clinical equivalence of SCT510 and bevacizumab.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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