Abstract
Background: Trastuzumab (TZB) is a fully-humanised monoclonal antibody biologic and antagonist of the human epidermal growth factor receptor-type 2 (HER2) receptor. It has significantly prolonged time to progression and survival of patients with HER2 positive metastatic breast cancer, as both a monotherapy or in combination with other agents. HLX02, the first China (CN)-manufactured TRZ biosimilar being investigated in a global setting, was developed to provide more cost-effective and readily available alternatives to TRZ. The clinical program followed the biosimilar guideline of China National Medical Products Administration (NMPA) and European Medicines Agency (EMA), which aims to increase global patient accessibility. We have reported the establishment of clinical PK bioequivalence between HLX02 and reference TZBs, later released Week 24 efficacy data. Here, we announce 1-year efficacy result and updated safety profile of the Phase 3 trial comparing HLX02 and European Union (EU)-sourced TRZ in metastatic breast cancer patients.
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