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

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer 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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引用次数: 0

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.

查看原文本刊更多论文

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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来源期刊

Clinical colorectal cancer 医学-肿瘤学

CiteScore

5.50

自引率

2.90%

发文量

审稿时长

27 days

期刊介绍： Clinical Colorectal Cancer is a peer-reviewed, quarterly journal that publishes original articles describing various aspects of clinical and translational research of gastrointestinal cancers. Clinical Colorectal Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of colorectal, pancreatic, liver, and other gastrointestinal cancers. The main emphasis is on recent scientific developments in all areas related to gastrointestinal cancers. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.