DISCUSSION
nonsquamous NSCLC, TEAEs
EMA
This Phase III biosimilar clinical study was conducted to compare efficacy, safety, PK, and immunogenicity of BAT1706 and EU‐bevacizumab in patients diagnosed with advanced nonsquamous NSCLC. Demographic and baseline characteristics were well‐balanced between the two treatment arms. Based upon equivalence margin criteria for biosimilarity stipulated by three international regulatory agencies (FDA, NMPA, and EMA), this study demonstrated the biosimilarity of BAT1706 and EU‐bevacizumab. The equivalence between BAT1706 and EU‐bevacizumab in terms of ORRThere were no notable differences between the two treatment arms regarding the incidence and severity of TEAEs and serious TEAEs, as well as changes in other safety parameters (laboratory, vital signs, and electrocardiogram). There were similar rates of BAT1706‐ and EU‐bevacizumab‐related TEAEs, along with comparable carboplatin‐ and paclitaxel‐related TEAEs, in the two treatment arms. Incidence rates of serious, Grade ≥3, and Grade ≥4 drug‐related TEAEs were also similar between treatment groups. PK and immunogenicity were also similar in the two treatment arms, with serum concentrations and exposure parameters comparable between BAT1706 and EU‐bevacizumab. Overall, the safety profile of BAT1706 was consistent with the known safety profile of reference bevacizumab published in the literature,It is worth mentioning that the use of bevacizumab plus platinum‐based chemotherapy (paclitaxel and carboplatin) is recommended in clinical practice as a standard treatment option for advanced or metastatic NSCLC.The goal of clinical trials on biosimilars is to demonstrate the totality of evidence on clinical equivalence,This study does have some potential limitations. Firstly, OS and PFS were not assessed as primary endpoints; however, it is important to note that this was a pivotal biosimilar clinical study designed to evaluate the clinical equivalence of BAT1706 and reference EU‐bevacizumab, and these endpoints are not sensitive for such an evaluation. Instead, the ORR