Jilin Cancer Hospital, 1066 Jinhu Road, High-Tech Zone, Changchun, Changchun, 130000, China.
Tianjin Cancer Hospital, Tianjin, China.
Adv Ther. 2024 Nov;41(11):4032-4048. doi: 10.1007/s12325-024-02965-z. Epub 2024 Sep 4.
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).
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.
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.
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.
NCT03792074.
SCT510 是一种与贝伐珠单抗（阿瓦斯汀）参比制剂（RP）相似的生物类似药，已获批准用于多种转移性癌症。在这项研究中，我们旨在证明 SCT510 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）方面与贝伐珠单抗相当。
非鳞状 NSCLC 患者被随机均等分配至 SCT510 组（包含 SCT510、紫杉醇和卡铂）和贝伐珠单抗组（包含贝伐珠单抗、紫杉醇和卡铂），接受 4-6 个周期的治疗，随后使用 SCT510 进行维持单药治疗。主要终点是第 12 周的客观缓解率（ORR）。次要终点包括 18 周 ORR、疾病控制率（DCR）、缓解持续时间（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 分析的评估。
在 2019 年 3 月 29 日至 2021 年 4 月 27 日期间，共筛选了 989 例患者，其中 567 例符合条件的患者被随机分配至 SCT510 组（285 例）和贝伐珠单抗组（282 例）。SCT510 组第 12 周的 ORR 为 52.6%（95%CI 46.66-58.55%），贝伐珠单抗组为 52.5%（95%CI 46.47-58.47%）。SCT510 组第 18 周的 ORR 为 55.4%（95%CI 49.46-61.30%），贝伐珠单抗组为 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 的等效性范围内。两组在其他次要终点方面没有差异，具体包括 DCR、DoR、PFS、OS 和 1 年生存率。两组的总体安全性发现相似，SCT510 和贝伐珠单抗 RP 均表现出较低的免疫原性。
SCT510 在晚期非鳞状 NSCLC 患者中的临床疗效、安全性、免疫原性和 PK 方面与贝伐珠单抗相当。所有证据均支持 SCT510 与贝伐珠单抗的临床等效性。
NCT03792074。
