A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results
European Journal of Cancer Apr 05, 2018
Pivot X, et al. - In view of a previous report suggesting equivalent efficacy between SB3 (a proposed trastuzumab biosimilar) and the trastuzumab reference product (TRZ) in terms of the breast pathologic complete response rate after neoadjuvant therapy in patients with early or locally advanced human epidermal growth factor receptor 2-positive breast cancer, researchers report the final safety, immunogenicity and survival results after neoadjuvant-adjuvant treatment. The biosimilarity established between SB3 and TRZ was further supported by the final safety, immunogenicity and survival results of this study. Between both treatment groups (SB3 vs TRZ), a comparable incidence of treatment-emergent adverse events was reported, with low overall incidence of antidrug antibody seen in both groups.
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