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PBI2 Real-World Evaluation of Biosimilar Bevacizumab-awwb versus Reference Bevacizumab in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer in a U.S. Integrated Healthcare Delivery System: 6-Month Interim Analysis

      Objectives

      The objective of this study was to evaluate the real-world effectiveness and safety outcomes of patients with advanced non-squamous non-small cell lung cancer (NSCLC) initiated on bevacizumab-awwb versus bevacizumab in a U.S. integrated healthcare delivery system.

      Methods

      This was an observational cohort study of all patients in Kaiser Permanente California with advanced NSCLC initiated on biosimilar bevacizumab-awwb between July 2019 and March 2020 or reference bevacizumab in 2015 to 2018. Patients with history of bevacizumab use in the 6 months prior to the index treatment date were excluded. The interim analysis data cutoff was at 6 months after treatment initiation, end of membership, or death, whichever occurred first. The primary outcome was all-cause mortality analyzed using Cox proportional-hazards modeling with adjustment for baseline age, sex, race, Charleston Comorbidity Index, concurrent chemotherapy, and history of surgical or radiation treatment. Secondary endpoints included counts of bevacizumab-awwb or bevacizumab doses received and incidence of serious adverse events.

      Results

      A total of 353 patients initiated on bevacizumab-awwb (n=58) and bevacizumab (n=295) were included in the analysis. The overall mean age was 63 ± 10 years and 54% of patients were female. The 6-month survival rate was 72% and 79% for patients receiving bevacizumab-awwb and bevacizumab, respectively (p=0.27). The adjusted hazard ratio for mortality was 1.4 (0.8-2.5, p=0.20). The bevacizumab-awwb and bevacizumab groups received 5.4 ± 3.2 and 5.6 ± 2.9 doses, respectively, during the study period (p=0.62). There were no observed differences in serious adverse events, including hemorrhage, gastrointestinal perforation, thromboembolism, and severe hypertension, between the 2 study groups.

      Conclusions

      Findings from this interim analysis indicate short-term effectiveness and safety of the biosimilar bevacizumab-awwb were comparable to reference bevacizumab for treatment of advanced NSCLC.