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Clinical Trial
. 2024 Nov;41(11):4032-4048.
doi: 10.1007/s12325-024-02965-z. Epub 2024 Sep 4.

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

Ying Cheng  1 , Zhanyu Pan  2 , Lin Wu  3 , Bo Zhu  4 , Yan Yu  5 , Kai Zang  6 , Wu Zhuang  7 , Lianke Liu  8 , Kangsheng Gu  9 , Juanwen Lian  10 , Rixin Chen  11 , Tao Bian  12 , Dang Lin  13 , Shenghua Sun  14 , Wei Li  15 , Xiaosheng Hang  16 , Ou Jiang  17 , Fukuan Zhong  18 , Rui Wang  19 , Hui Luo  20 , Huaqiu Shi  21 , Zonghui Wei  22 , Li Zhao  23 , Shaoshui Chen  24 , Hongmei Sun  25 , Xingya Li  26 , Debin Sun  27 , Tiejun Ren  28 , Kaijian Lei  29 , Miao He  30 , Gaofeng Li  31 , Hailong Liu  32 , Runpu Li  33 , Chunhong Hu  34 , Li Kong  35 , Meili Sun  36 , Liangzhi Xie  37 , Wenlin Gai  37 , Weiqiu Chen  37 , Zhe Huang  37 , Wenwen Ren  37 , Huo Su  37
Affiliations
Clinical Trial

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

Ying Cheng et al. Adv Ther. 2024 Nov.

Abstract

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.

Trial registration: NCT03792074.

Keywords: Immunotherapy; Non-small cell lung cancer; Randomized controlled trial; SCT510.

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