Fosun International Limited's Henlius recently announced the presentation of updated phase 2 results and the design for a phase 3 clinical trial of their anti-HER2 monoclonal antibody, HLX22, targeting first-line HER2-positive gastric cancer. The announcement was made at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The phase 2 study results highlight the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy, with over two years of follow-up data. The phase 3 trial, HLX22-GC-301, will compare HLX22 with the current standard of care therapy, enrolling approximately 550 patients globally. The trial will evaluate progression-free survival and overall survival as dual primary endpoints. Additionally, HLX22's scope has expanded to include breast cancer, with a phase 2 trial for HER2-low, hormone receptor-positive breast cancer underway in China.
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