A Bevacizumab Biosimilar Shows Promise for Non-Small Cell Lung Cancer

BAT1706 was clinically equivalent to the reference bevacizumab for efficacy, safety, pharmacokinetics, and immunogenicity.

The National Cancer Institute estimated 238,340 new cases of lung and bronchus cancer in the United States in 2023, which accounted for 12.2% of all new cancer cases and 20.8% of all cancer deaths. Furthermore, the Institute noted a 5-year survival rate of 25.4% from 2013 to 2019.¹

3d rendered illustration of lung cancer 3D illustration

Image credit: appledesign | stock.adobe.com

Lung cancer’s 2 main subcategories include non-small cell lung cancer (NSCLC) and small cell lung cancer. Chemotherapy for NSCLC can consist of targeted therapy to treat advanced, metastatic, or recurrent disease and 4 types of targeted therapy are monoclonal antibodies, tyrosine kinase inhibitors, mammalian target of rapamycin inhibitors, and KRAS G12C inhibitors. Vascular endothelial growth factor (VEGF) inhibitor therapy is a specific monoclonal antibody therapy which blocks VEGF and stops new blood vessel formation with resultant cancer cell death.² Patients are frequently given bevacizumab (Avastin), a VEGF inhibitor, in combination with paclitaxel and carboplatin for the first-line treatment of late-stage NSCLC.³

A group of investigators conducted a multicenter, randomized, double-blind, phase 3, parallel, 2-arm study comparing the efficacy and safety of BAT1706, a proposed biosimilar of bevacizumab, with that of European Union (EU)-sourced reference bevacizumab (EU-bevacizumab) in 649 patients with advanced nonsquamous NSCLC. The researchers randomized patients 1:1 to receive either BAT1706 plus paclitaxel and carboplatin (BAT1706 arm, n = 325) or EU-bevacizumab plus paclitaxel and carboplatin (EU-bevacizumab arm, n = 324) given every 3 weeks for 6 cycles, followed by maintenance therapy with BAT1706 or EU-bevacizumab.³

The primary endpoint was overall response rate at week 18 (ORR18). The results noted a comparable ORR18 between the BAT1706 and EU-bevacizumab arms (48.0% and 44.5%, respectively). In addition, the safety assessment for BAT1706 was consistent with that of EU-bevacizumab with no new safety alerts noted.³

This study concluded that BAT1706 was clinically equivalent to EU-bevacizumab for efficacy, safety, pharmacokinetics, and immunogenicity when used in combination with paclitaxel and carboplatin for the treatment of patients with advanced nonsquamous NSCLC.³

About the Author

Bragadeesh R. Iyer, PharmD, BCGP, CSP, is a clinical pharmacist and a student in the University of Connecticut Medical Writing Program.

References

1. SEER Cancer Stat Facts: Lung and Bronchus Cancer. National Cancer Institute. Bethesda, MD. Accessed January 29, 2024. https://seer.cancer.gov/statfacts/html/lungb.html

2. PDQ Adult Treatment Editorial Board. PDQ Non-Small Cell Lung Cancer Treatment. Bethesda, MD: National Cancer Institute. Updated 10/11/2023. Accessed January 29, 2024. https://www.cancer.gov/types/lung/patient/non-small-cell-lung-treatment-pdq.

3. Chen L, Rangel JDG, Cil T, et al. Efficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non-small cell lung cancer: A randomized, double-blind, phase III study. Cancer Med. 2023;12(22):20847-20863.