A large-scale retrospective analysis has validated the therapeutic equivalence of bevacizumab biosimilars compared to the reference product Avastin in treating locally advanced or metastatic non-small cell lung cancer (NSCLC), offering promising implications for healthcare cost reduction and treatment accessibility.
The study, published in Frontiers of Oncology, examined 1,058 patients between January 2021 and December 2023, with 606 receiving biosimilar treatment and 452 receiving the reference product. All patients received a standard dosing regimen of 15 mg/kg intravenously every 21 days.
Efficacy and Clinical Outcomes
The analysis revealed comparable efficacy between biosimilars and the reference product. The biosimilar group achieved an overall response rate (ORR) of 27.41% (95% CI, 24.1%-31%), while the reference group showed an ORR of 29.79% (95% CI, 26.5%-32%). Notably, no complete responses were observed in either group, with partial responses and stable disease being the predominant outcomes.
Key patient characteristics, including smoking history, performance status, stage at diagnosis, and comorbidities, showed significant associations with survival status (P < .05). However, the choice between biosimilar and reference treatment did not significantly impact survival outcomes.
Safety Profile and Adverse Events
The safety analysis demonstrated a consistent profile between biosimilars and the reference product, with 76.42% of patients experiencing adverse events. Most adverse events were grade 1 or 2, with no statistically significant differences in severe adverse events between groups.
Common treatment-emergent adverse events included:
- Anemia (9.15% in biosimilar group, 15.33% in reference group)
- Fever (8.71% in biosimilar group)
- Other events: fatigue, pneumonia, leukopenia, neutropenia, and thrombocytopenia
A notable finding was an increased risk of hypertension in patients over 70 years receiving high-dose biosimilar treatment (P < .05), though this difference disappeared when excluding patients with pre-existing hypertension.
Market Impact and Accessibility
The FDA has approved five bevacizumab biosimilars to date, including:
- Mvasi (bevacizumab-awwb) by Amgen
- Zirabev (bevacizumab-bvzr) by Pfizer
- Alymsys (bevacizumab-maly) by Amneal Pharmaceuticals
- Vegzelma (bevacizumab-adcd) by Celltrion Healthcare
- Avzivi (bevacizumab-tnjn) by Bio-Thera Solutions
This growing availability of biosimilars presents an opportunity to reduce healthcare costs while maintaining treatment efficacy, particularly important given that lung cancer remains the leading cause of cancer-related deaths globally.
Study Limitations and Future Directions
The researchers acknowledged several limitations, including the retrospective design's inherent biases and the challenge of balancing patient characteristics between groups. Short follow-up periods also limited insights into long-term survival benefits.
The study authors emphasized that "Future research is essential to refine safety assessments, optimize patient benefit, minimize risks, and support evidence-based adoption of biosimilars in oncology." This ongoing research will be crucial for advancing precision medicine and ensuring equitable access to effective cancer treatments.
