Bevacizumab Biosimilar Demonstrates Efficacy, Acceptable Toxicity Compared to Reference Bevacizumab for Patients With Locally Advanced and Advanced NSCLC

According to findings from a retrospective study published in Frontiers in Oncology, bevacizumab biosimilar demonstrated efficacy comparable to bevacizumab among patients with locally advanced and advanced non-small-cell lung cancer (NSCLC), with an acceptable toxicity profile and no new adverse events.

Reference bevacizumab, a recombinant humanized monoclonal antibody, is used for the systemic treatment of patients with advanced NSCLC without gene mutations. Its biosimilar, if proven to be safe and effective, can potentially reduce financial strain on both patients and healthcare systems while providing effective clinical treatment.

“In recent years, bevacizumab biosimilar has received marketing approval based on the results of phase [3] clinical studies,” wrote Zhiting Zhao, MD, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China, and colleagues. “However, more clinical data are needed to verify the efficacy and safety of bevacizumab biosimilar in clinical application.”

This retrospective study focused on 946 patients with locally advanced or metastatic NSCLC who were treated with bevacizumab biosimilar or bevacizumab from the time period of January 2019 to November 2021. The researchers made comparisons and statistical analyses of bevacizumab biosimilar and bevacizumab in terms of efficacy and safety. They based their efficacy evaluation on RECIST v1.1, while they graded adverse events following the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.

Objective response rate (ORR) was found to be 28.9% in the biosimilar group (n=551) and 30.9% in the reference group (n=395; unstratified ORR risk ratio: 0.934, 95% confidence interval [CI], 0.677 to 1.138; unstratified ORR risk difference: −0.020, 95% CI, −0.118 to 0.035). The estimated median progression-free survival (PFS) was 6.27 (95% CI, 5.53 to 7.01) and 4.93 (95% CI, 4.24–5.62) months in the biosimilar and reference groups, respectively (P=0.296). The number of treatment lines, combined treatment regimens and with or without radiotherapy were significant factors affecting the PFS of both groups (P<0.001, P=0.001, P=0.039). Different genetic mutations and dose intensity were not the main factors affecting PFS (P=0.627, P=0.946). Overall, incidences of treatment-emergent adverse events were 76.41% in the biosimilar group and 71.65% in the reference group (P=0.098). The incidences of grade 3 or higher treatment-emergent adverse events were 22.14% and 19.49% in the biosimilar and reference groups, respectively (P=0.324).

“Bevacizumab biosimilar is equivalent in efficacy to bevacizumab in patients with locally advanced and advanced NSCLC,” Zhao and coauthors concluded. “It showed acceptable toxicity profile and no new adverse events.” They added, “Patients who were excluded by clinical trials can also benefit from bevacizumab biosimilar."

Source:

Zhao Z, Zhao L, Xia G, et al. Efficacy and safety of bevacizumab biosimilar compared with reference bevacizumab in locally advanced and advanced non-small cell lung cancer patients: A retrospective study. Front Oncol. Published online Jan 29, 2023. doi:10.3389/fonc.2022.1036906