Biosimilar SB8 Is Comparable to Bevacizumab for Non–Small Cell Lung Cancer

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Bevacizumab is a recombinant humanized G1 monoclonal anti-vascular endothelial growth factor antibody that is used in combination with chemotherapy to treat solid tumors.

The efficacy of bevacizumab (Avastin; Genentech, Roche) from the European Union (bevacizumab-EU) is comparable to the biosimilar of bevacizumab, SB8 (Samsung Bioepis), in overall survival (OS) and progressive free survival (PFS) for non­–small cell lung cancer (NSCLC), according to results of a study published in Frontiers in Pharmacology.

3d rendered illustration of lung cancer 3D illustration | Image Credit: appledesign - stock.adobe.com

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Bevacizumab is a recombinant humanized G1 monoclonal anti-vascular endothelial growth factor antibody that is used in combination with chemotherapy to treat solid tumors, according to the study authors. SB8 (Aybintio) was approved for the same cancers as the reference drug in the European Union. In the study, investigators aimed to find the exposure–response relationship for bevacizumab compared to bevacizumab-EU in patients with advanced NSCLC and evaluate the therapeutic efficacy of the 2 drugs based on exposure.

3 Key Takeaways

  1. The study indicates that bevacizumab-EU and its biosimilar SB8 demonstrate comparable overall survival (OS) and progressive free survival (PFS) rates in patients with non-small cell lung cancer (NSCLC), suggesting similar therapeutic efficacy.
  2. Investigators utilized a parametric time-to-event (TTE) model to analyze the relationship between drug exposure and clinical outcomes.
  3. The study underscores the importance of considering patient demographics, clinical covariates, and drug exposure levels in evaluating treatment efficacy.

Investigators used clinical data from 224 individuals in a phase 3 study (SB8-G31-NSCLC; NCT02754882) that compared both drugs in the treatment of metastatic or recurrent non-squamous NSCLC. Individuals randomly received SB8 or the reference product at 15 mg/kg intravenously with paclitaxel at 200 mg/m2 and carboplatin every 3 weeks for 4 to 6 cycles of the induction period. Tumors were assessed with radiographic imaging and patients who had complete or partial responses or stable diseases after the induction period then received maintenance therapy. The dosages for both drugs were 15 mg/kg intravenously every 3 weeks until progressive disease, toxicity, death, or the end of the study. Exposure­–response analysis included OS and PFS, according to the study authors.

According to the study investigators, they developed a parametric time-to-event (TTE) model using NONlinear Mixed Effects Modeling. The model used the effects of treatment, patient demographics, and clinical covariates to determine OS and PFS.

“The exploratory analyses for OS and PFS using the combined data (SB8 + bevacizumab-EU) and separate data by the treatment group show comparable survival curves between SB8 and bevacizumab-EU,” the study authors wrote. A long-rank test showed that there were no differences in both drugs for OS and PFS and the estimated hazard ratios were 1.13 and 1.07, respectively.

The investigators found that treatment was not a predictor of the hazard OS or PFS, according to the results. They noted that the model showed a steep exposure–response curve with a rapid rise before it plateaued, according to the investigator authors. Steady-state trough concentrations values of both drugs were on the plateaued point of the exposure–response curve, according to the study. The concentrations to achieve 50% to 9% were 82.4 and 92.2 μg/mL for OS, respectively, and 79.7 and 89.1 μg/mL for PFS, respectively.

According to the study authors, this was the first study to publish results after a TTE model-based simulation approach. Further, investigators said the clinical factors for patient survival were worth noting. The hazard of OS increased with decreasing body mass index (BMI) and weight, though the increase was not statistically significant. The authors added that this remained consistent with other findings related to BMI and weight.

The authors concluded that their model helped to further the similarities for treatment between SB8 and bevacizumab-EU.

Reference

Park S, Jung JA, Ju S, Lim HS. Exposure-response analysis using time-to-event data for bevacizumab biosimilar SB8 and the reference bevacizumab. Front Pharmacol. 2024;14:1288308. Published 2024 Jan 16. doi:10.3389/fphar.20

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