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Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in
Winson Y Cheung1, Setareh Samimi2, Kim Ma3
1Tom Baker Cancer Centre, Calgary, AB, 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.
Insights
Real-world evidence shows ABP 215, a biosimilar for metastatic colorectal cancer, has comparable safety and effectiveness to bevacizumab. This study provides valuable insights into patient characteristics and treatment outcomes in Canada.
Area of Science:
- Oncology
- Pharmacology
- Clinical Research
Background:
- ABP 215 is a biosimilar to bevacizumab, approved for first-line metastatic colorectal cancer (mCRC) treatment in Canada.
- Real-world evidence (RWE) gaps existed regarding patient characteristics, safety, and effectiveness of ABP 215 in Canadian mCRC patients.
Purpose of the Study:
- To evaluate patient characteristics, treatment safety, and effectiveness of first-line ABP 215 therapy in Canadian mCRC patients.
- To address existing gaps in real-world evidence for ABP 215 in mCRC.
Main Methods:
- Retrospective data collection in two waves, at least one or two years post-commercial availability of ABP 215.
- Inclusion of 75 patients (Wave 1) and 164 patients (Wave 2) who received at least one cycle of ABP 215.
Main Results:
- Safety events of interest occurred in 34.7% (Wave 1) and 42.7% (Wave 2) of patients.
- Median progression-free survival (PFS) was 9.47 months (Wave 1) and 21.38 months (Wave 2).
- Median overall survival was not estimable (Wave 1) and 26.45 months (Wave 2).
Conclusions:
- Real-world safety and effectiveness of ABP 215 were comparable to clinical trial findings.
- Observed outcomes align with other RWE, demonstrating longer PFS in this study.
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