Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer

• Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy Vol. 37; no. 6; pp. 891 - 899
• Main Authors: Pham, Catherine, Niu, Fang, Delate, Thomas, Buchschacher, Gary L., Li, Yan, Ekinci, Ekim, Le, Kim, Hui, Rita L.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.11.2023; Springer Nature B.V
• Subjects: Adult; Aged; Antibodies; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab; Bevacizumab - therapeutic use; Biological products; Biomedical and Life Sciences; Biomedicine; Biosimilar Pharmaceuticals - therapeutic use; Cancer Research; Cancer therapies; Clinical outcomes; Cohort analysis; Cohort Studies; Colorectal cancer; Colorectal carcinoma; Colorectal Neoplasms - drug therapy; Cost control; Data collection; Drug dosages; Emergency medical care; FDA approval; Female; Health care delivery; Humans; Longitudinal Studies; Male; Market entry; Metastases; Metastasis; Middle Aged; Molecular Medicine; Mortality; Original Research Article; Patients; Pharmacotherapy; Pharmacy; Statistical analysis; United States > US
• ISSN: 1173-8804; 1179-190X
• DOI: 10.1007/s40259-023-00624-3

Background Bevacizumab-awwb was the first biosimilar approved for cancer treatment in the USA. Limited information is available on the real-world comparative safety and effectiveness of bevacizumab biosimilars, especially for indications granted approval through extrapolation. Objective To evaluate the real-world outcomes of patients with metastatic colorectal cancer (mCRC) initiated on bevacizumab-awwb versus bevacizumab reference product. Patients and Methods This was an observational, longitudinal cohort study of US adult patients with mCRC from four integrated care delivery systems who were newly initiated on bevacizumab-awwb between 1 July 2019 and 30 March 2020 or bevacizumab reference product between 1 July 2015 and 30 June 2018. Patients were followed until 1 year after treatment initiation, end of plan membership, or death, whichever occurred first. The primary outcome of overall survival (OS) was analyzed using a binary non-inferiority test with lower margin of 10% and adjusted Cox proportional hazards regression analysis to assess all-cause mortality if non-inferiority was met. Secondary outcomes included counts of doses received, treatment duration, all-cause hospitalizations, and incidence of serious adverse events. Results A total of 1445 patients initiated on either bevacizumab-awwb ( n = 239) or bevacizumab reference product ( n = 1206) were included in the analysis. The mean overall age was 60 ± 13 years, 46% of patients were female, and 51% were white. The OS rate was 72.8% and 73.1% for patients receiving bevacizumab-awwb and bevacizumab reference product, respectively ( p < 0.01 for non-inferiority). The adjusted hazard ratio for mortality was 1.01 (0.77–1.33, p = 0.93). There were no statistically significant differences in secondary outcomes between the study groups. Conclusions These findings suggest that bevacizumab-awwb is as effective and safe as bevacizumab reference product for the real-world treatment of mCRC.