Abstract
BACKGROUND: The bevacizumab biosimilar (Encoda), which was approved by the National Medical Products Administration (NMPA) in China in 2019, is a biosimilar of bevacizumab. Approval of bevacizumab biosimilar (Encoda) for metastatic colorectal cancer (mCRC) was based on the extrapolation principle of biosimilar. However, there is currently no available data regarding the efficacy and safety of both bevacizumab biosimilar (Encoda) and bevacizumab in patients with mCRC. METHODS: The present real-world study included patients with mCRC who received first-line therapy with either bevacizumab biosimilar (Encoda) or bevacizumab combined with backbone chemotherapy between April 2021 and December 2022. The overall response rate (ORR) was the primary endpoint of the study. Bevacizumab biosimilar (Encoda) would be considered equivalent to bevacizumab if it met any of the following criteria: the 90% CI for ORR risk ratio of bevacizumab biosimilar (Encoda): bevacizumab was included within the predefined equivalence range (0.75 to 1.33) as specified by the NMPA or within the predefined equivalence range (0.73 to 1.36) as specified by US Food and Drug Administration (FDA); the 95% CI for the ORR risk difference of 2 groups was included within the predefined equivalence range (-0.12 to 0.15) as specified by the European Medicines Agency (EMA). RESULTS: The study included a total of 436 patients, with 234 receiving bevacizumab biosimilar (Encoda) and 202 receiving bevacizumab. The ORR was 42.3% (95% CI: 35.9% to 48.9%) in the bevacizumab biosimilar (Encoda) group and 42.1% (95% CI: 35.2% to 49.2%) in the bevacizumab group. The ORR risk ratio and risk difference were 1.005 (90% CI: 0.836 to 1.210) and 0.002 (95% CI: -0.091 to 0.095), respectively, both included within the prespecified equivalence range. The overall safety profile was comparable between the 2 groups. CONCLUSIONS: This real-world study is the first to demonstrate the efficacy equivalence of bevacizumab biosimilar (Encoda) and bevacizumab in first-line treatment of mCRC.