ABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC. Retrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site. A total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2. The safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study.

中文翻译：

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贝伐单抗生物仿制药 (ABP 215) 在加拿大转移性结直肠癌患者中的真实安全性和有效性

ABP 215 是参考产品贝伐珠单抗的生物仿制药，是加拿大卫生部批准用于一线治疗转移性结直肠癌 (mCRC) 的首批生物仿制药之一。本研究旨在解决现实世界证据 (RWE) 中的差距，包括加拿大 mCRC 患者一线 ABP 215 治疗的患者特征、治疗安全性（主要目标）和有效性（次要目标）。在每个参与地点 ABP 215 商业上市后至少 1 年（第 1 波）或 2 年（第 2 波）分 2 波收集回顾性数据。总共纳入了第 1 波中的 75 名患者和第 2 波中的 164 名患者，接受了至少 1 个周期的 ABP 215 治疗。34.7% 的第 1 波患者和 42.7% 的第 2 波患者至少记录了一次感兴趣的安全事件 (EOI)。第 1 波和第 2 波患者的中位无进展生存期 (PFS) 分别为 9.47（95% 置信区间 [CI]：6.71, 11.90）和 21.38（95% CI：15.82，不可估计）个月。第 1 波的中位总生存期无法估计，第 2 波的中位总生存期为 26.45 个月。在这项现实世界研究中观察到的 ABP 215 的安全性和有效性与临床试验结果以及当前研究中具有较长 PFS 的其他 RWE 相当。