Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in Canada

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2024-03-01 DOI:10.1016/j.clcc.2023.10.007

Winson Y. Cheung , Setareh Samimi , Kim Ma , Gregory John Knight , Shaqil Kassam , Bruce Colwell , Annie Beaudoin , Mark David Vincent , Mateya Trinkaus , Alain Filion , Katerine Marquis , Hatim Karachiwala , Timothy Asmis , Lucas Sideris , Rajvi J. Wani , Elaine Ngan , Naila Inam , Yinhao Du , Leyla Nunez , Maria Eberg , Carlye Cirone Morris

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Abstract

Background

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.

Materials and Methods

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.

Results

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.

Conclusion

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.

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贝伐珠单抗生物类似物（ABP 215）在加拿大转移性结直肠癌患者中的实际安全性和有效性

背景ABP 215是参比产品贝伐珠单抗的生物仿制药，是加拿大卫生部批准用于转移性结直肠癌（mCRC）一线治疗的首批生物仿制药之一。本研究旨在解决加拿大mCRC患者一线ABP 215治疗的患者特征、治疗安全性（首要目标）和有效性（次要目标）等真实世界证据（RWE）方面的差距。材料与方法分2次收集回顾性数据，在每个参与研究的机构ABP 215商业化后至少1年（第1次）或2年（第2次）。34.7%的第1波患者和42.7%的第2波患者至少发生了一次相关安全事件（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 个月（95% 置信区间 [CI]：6.71, 11.90）和 21.38 个月（95% 置信区间：15.82，无法估计）。第1波患者的中位总生存期无法估计，第2波患者的中位总生存期为26.45个月。结论在这项真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PFS更长的其他RWE相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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