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

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

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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

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.