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
{"title":"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","authors":"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","doi":"10.1016/j.clcc.2023.10.007","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Materials and Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":3,"journal":{"name":"ACS Applied Electronic Materials","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1533002823000944/pdfft?md5=c5b19261efb6c944060160487270dab5&pid=1-s2.0-S1533002823000944-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in Canada\",\"authors\":\"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\",\"doi\":\"10.1016/j.clcc.2023.10.007\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Materials and Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>\",\"PeriodicalId\":3,\"journal\":{\"name\":\"ACS Applied Electronic Materials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1533002823000944/pdfft?md5=c5b19261efb6c944060160487270dab5&pid=1-s2.0-S1533002823000944-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Electronic Materials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1533002823000944\",\"RegionNum\":3,\"RegionCategory\":\"材料科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENGINEERING, ELECTRICAL & ELECTRONIC\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Electronic Materials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1533002823000944","RegionNum":3,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENGINEERING, ELECTRICAL & ELECTRONIC","Score":null,"Total":0}
Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in Canada
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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