The treatment shows an acceptable toxicity profile and no new adverse events, according to results of analysis.
The bevacizumab biosimilar is equivalent in efficacy to bevacizumab in patients with advanced and locally advanced non-small-cell lung cancer (NSCLC), according to the results of a study recently published in Frontiers in Oncology.
The bevacizumab biosimilar showed an acceptable toxicity profile and no new adverse events (AEs).
Bevacizumab has played a role in the systemic treatment of patients with advanced NSCLC without gene mutation. Prospective clinical trials have confirmed that the bevacizumab biosimilar in combination with platinum-containing 2-drug chemotherapy has similar efficacy and safety to bevacizumab in patients with untreated advanced NSCLC.
Although the bevacizumab biosimilar has received marketing approval from the China National Medical Products Administration based on the results of phase 2 studies, more clinical data are needed to verify the efficacy and safety of the bevacizumab biosimilar in clinical applications, investigators said.
The study retrospectively analyzed and compared the efficacy and safety of the bevacizumab biosimilar and the reference bevacizumab drug in patients with advanced and locally advanced NSCLC in clinical applications. The study was conducted with the intention of providing a reference for clinical decision-making.
Patients were identified through medical records of patients with advanced and locally advanced non-squamous NSCLC treated at Jiangsu Cancer Hospital between January 1, 2019, and November 30, 2021. All patients included in the study were screened for the bevacizumab biosimilar or bevacizumab treatment and had at least 1 measurable disease.
The study included 946 patients with locally advanced or metastatic NSCLC who were treated with bevacizumab or the bevacizumab biosimilar. Of these patients, 551 received the bevacizumab biosimilar (biosimilar group) and 395 patients received bevacizumab (reference group). Baseline disease and demographic characteristics were balanced between the treatment groups with no statistical differences.
Comparisons and statistical analyses of bevacizumab and the biosimilar were made in terms of efficacy and safety, and efficacy evaluation was performed directly in accordance with RECIST v1.1. Investigators graded AEs following the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. The primary efficacy endpoint was the objective response rate (ORR), and the secondary efficacy endpoint was the progression-free survival (PFS), defined as the time from treatment initiation to clinical or radiographic progression or death.
The ORR was 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]: 0.677–1.138; unstratified ORR risk difference: −0.020, 95% CI: −0.118–0.035). The estimated median PFS was 6.27 (95% CI: 5.53–7.01) and 4.93 (95% CI: 4.24–5.62) months in the biosimilar and reference groups, respectively (P = 0.296).
Factors affecting the ORR and PFS of bevacizumab or the biosimilar included number of treatment lines, combined treatment regimens, and radiotherapy (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).
The AE spectra and incidence rates of both products were similar. The incidences of treatment-emergent AEs were 76.41% and 71.65% in the biosimilar and references group, respectively (P = 0.098). The incidence of grade 3 or higher treatment or higher treatment-emergent AEs was 22.14% in the biosimilar group and 19.49% in the reference group (P = 0.324).
These findings suggest that the bevacizumab biosimilar is equivalent in efficacy to bevacizumab in patients with advanced and locally advanced NSCLC, showing acceptable toxicity profile and no new AEs.
Patients who were excluded by clinical trials can also benefit from the bevacizumab biosimilar, according to the authors.
Patients receiving previous treatment or regimens other than in combination with chemotherapy or those with brain metastases or rare genetic mutations were found able to benefit clinically from both products.
However, the authors suggested that larger prospective studies are needed to confirm the findings, given the limitations of the retrospective study design and reliance on electronic health records.
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. Fron. Oncol. 2023;12. doi:10.3389/fonc.2022.1036906