BAT1706 是贝伐珠单抗 (Avastin®) 的拟议生物仿制药。我们的目的是比较 BAT1706 与欧盟参比贝伐单抗 (EU-bevacizumab) 在晚期非鳞状非小细胞肺癌 (NSCLC) 患者中的疗效和安全性。患者按 1:1 随机分配至 BAT1706 加紫杉醇和卡铂组（BAT1706 组）或 EU-贝伐单抗加紫杉醇和卡铂（EU-贝伐单抗组）每 3 周一次，持续六个周期，然后用 BAT1706 或 EU-贝伐单抗维持治疗。主要终点是第 18 周的总体缓解率 (ORR18)。如果 BAT1706:EU-贝伐珠单抗 ORR18 风险比的 90% 置信区间 (CI) 包含在 0.75-1.33（中国国家药品监督管理局要求）或 0.73-1.36（美国食品药品监督管理局要求）的预定义等效范围内，则证明临床等效性和药物管理局），或者如果治疗之间 ORR18 风险差异的 95% CI 包含在 -0.12 至 0.15 的预定义等效边界内（EMA 要求）。总共 649 名随机患者（BAT1706，n = 325；EU-贝伐珠单抗，n = 324）接受了至少一个周期的联合治疗。 BAT1706 组和 EU-贝伐单抗组之间的 ORR18 相当（分别为 48.0% 和 44.5%）。 ORR18 风险比为 1.08（90% CI：0.94-1.24），ORR18 风险差为 0.03（95% CI：-0.04 至 0.11），均在预定义的等效范围内，证明了 BAT1706 和 EU-贝伐珠单抗的生物相似性。 BAT1706 的安全性与 EU-贝伐单抗一致，未观察到新的安全信号。在晚期非鳞状 NSCLC 患者中，BAT1706 在疗效、安全性、药代动力学和免疫原性方面与 EU-贝伐单抗具有临床等效性。© 2023作者们。约翰·威利出版的癌症医学

BAT1706 is a proposed biosimilar of bevacizumab (Avastin®). We aimed to compare the efficacy and safety of BAT1706 with that of EU-sourced reference bevacizumab (EU-bevacizumab) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).Patients were randomized 1:1 to BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) or EU-bevacizumab plus paclitaxel and carboplatin (EU-bevacizumab arm) given every 3 weeks for six cycles, followed by maintenance therapy with BAT1706 or EU-bevacizumab. The primary endpoint was overall response rate at week 18 (ORR18 ). Clinical equivalence was demonstrated if the 90% confidence interval (CI) of the BAT1706:EU-bevacizumab ORR18 risk ratio was contained within the predefined equivalence margins of 0.75-1.33 (China National Medical Products Administration requirements), or 0.73-1.36 (US Food and Drug Administration), or if the 95% CI of the ORR18 risk difference between treatments was contained within the predefined equivalence margin of -0.12 to 0.15 (EMA requirements).In total, 649 randomized patients (BAT1706, n = 325; EU-bevacizumab, n = 324) received at least one cycle of combination treatment. The ORR18 was comparable between the BAT1706 and EU-bevacizumab arms (48.0% and 44.5%, respectively). The ORR18 risk ratio of 1.08 (90% CI: 0.94-1.24) and the ORR18 risk difference of 0.03 (95% CI: -0.04 to 0.11) were within the predefined equivalence margins, demonstrating the biosimilarity of BAT1706 and EU-bevacizumab. The safety profile of BAT1706 was consistent with that of EU-bevacizumab and no new safety signals were observed.In patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU-bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.