Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the dosing of the first patient in a global, multi-center Phase III study for its drug candidate HLX22. The study will compare the combination of HLX22 with trastuzumab and chemotherapy against the same regimen with or without pembrolizumab in the first-line treatment of locally advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC).
HLX22: A Humanized Monoclonal Antibody Targeting HER2
HLX22 is a humanized IgG1 monoclonal antibody (mAb) injection that targets human epidermal growth factor receptor 2 (HER2). Henlius obtained the rights to develop and commercialize HLX22 from South Korea-based AbClon Inc. in an agreement signed in October 2016. The drug is being developed to treat gastric cancer, breast cancer, and other solid tumors, having already completed a Phase I study in HER2 over-expressing advanced solid tumors.
Primary Endpoints and Study Design
The Phase III study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for first-line HER2 positive GC/GEJC. The primary endpoints of the trial include progression-free survival (PFS) and overall survival (OS), which will be assessed by the Independent Radiology Review Committee (IRRC) based on RECIST v1.1 criteria.-Fineline Info & Tech
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