Bevacizumab biosimilar (Celltrion)

Biosimilars like Vegzelma can significantly enhance access to biologic therapies and reduce healthcare costs, provided that comprehensive stability data is available. This study aimed to provide extended stability data, allowing hospitals and healthcare professionals to effectively manage drug preparation, minimize wastage, and optimize cost-efficiency. The stability assessments employed in this study included ion exchange chromatography, steric exclusion chromatography, dynamic light scattering, and measurements of pH, density, and osmolality. These assessments focused on the physicochemical stability of the bevacizumab biosimilar (Vegzelma) in vials and polyolefin infusion bags when diluted to concentrations of 1.4 and 16.5mg/mL in 0.9% NaCl and stored at temperatures between 2 to 8°C and at 25°C. Results from stability and sterility assays confirm that when diluted in 0.9% NaCl and stored in polyolefin IV bags, Vegzelma remains stable at the commonly used concentrations of 1.4 and 16.5mg/mL for a 96-hour thermal cycle. For opened vials, the study extends the stability period to 60 days at 2-8°C under light-protected conditions. Unopened vials can be safely stored at room temperature, protected from light, for up to 72hours without compromising the product's integrity. All analyses, particle sizing, ion exchange chromatography, spectral analysis, and thermal denaturation, indicated stable molecular and structural integrity of the bevacizumab, with no observed changes in aggregation, ionic distribution, tertiary structure, or thermodynamic properties. These findings demonstrate the biosimilar's resilience against a 72-hour temperature spike. Pharmacies could use this data for flexible treatment scheduling, advanced preparation for weekends, and holidays, resulting in cost-efficiencies with biosimilars.

Data from the CT-P16 3.1 study demonstrated equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) for the primary endpoint of objective response rate (ORR) during induction treatment in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). We now present long-term findings.

In this randomized, double-blind, multicenter phase 3 study, patients with metastatic or recurrent non-squamous NSCLC received CT-P16 or EU-bevacizumab (15 mg/kg every 3 weeks; ≤6 cycles) together with paclitaxel (200 mg/m²) and carboplatin (area under the curve 6.0) for 4-6 cycles during the induction period. Patients with controlled disease entered the maintenance period, continuing with CT-P16 or EU-bevacizumab as monotherapy until disease progression/intolerable toxicity. They were then followed up every 9 weeks until death or end of study. Outcomes were evaluated ≤3 years after the last patient enrollment.

Of 689 patients receiving CT-P16 (N = 342) or EU-bevacizumab (N = 347), 499 (72.4 %) completed the induction period (CT-P16, n = 258 [75.4 %]; EU-bevacizumab, n = 241 [69.5 %]), 466 (67.6 %) initiated the maintenance period (CT-P16, n = 239 [69.9 %]; EU-bevacizumab, n = 227 [65.4 %]), and 389 (56.5 %) entered follow-up (CT-P16, n = 190 [55.6 %]; EU-bevacizumab, n = 199 [57.3 %]). Whole study ORRs were similar for CT-P16 (45.61 % [95 % confidence interval 40.34-50.89]) and EU-bevacizumab (46.11 % [95 % confidence interval 40.86-51.35]). Response duration, time to progression, progression-free survival, and overall survival were similar. No new safety signals were detected.

Long-term results of the CT-P16 3.1 study confirm equivalent efficacy of CT-P16 and EU-bevacizumab in patients with metastatic or recurrent non-squamous NSCLC.

NCT03676192.

Equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) was demonstrated in a phase 3 study of patients with metastatic or recurrent non-squamous NSCLC. Long-term findings in 689 patients confirmed equivalent efficacy of CT-P16 and EU-bevacizumab; objective response rates were 45.6 % and 46.1 %, respectively. Response duration, time to progression, progression-free survival, and overall survival were also similar.