China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its ARX788, an anti-HER2 monoclonal antibody conjugate with AS269, in patients with HER2-positive cholangiocarcinoma. This approval marks a significant step in the clinical development of ARX788 for this indication.
ARX788: Clinical Development and Partnerships
ARX788, co-developed by US firm Ambrx Biopharma, Inc., is currently undergoing two Phase II/III clinical studies. These studies are evaluating the drug in HER2-positive locally advanced or metastatic breast cancer and HER2-positive advanced metastatic gastric cancer and gastroesophageal junction adenocarcinoma. Earlier this year, a Phase I study was initiated for ARX788 in combination with the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in advanced solid tumors with HER2 expression or mutation.
Global HER2-Targeted Cancer Therapies Market
The global market for HER2-targeted cancer therapies includes Roche’s trastuzumab and ado-trastuzumab emtansine, AstraZeneca/Daiichi Sankyo’s fam-trastuzumab deruxtecan, and RemeGen’s disitamab vedotin. The first three are already marketed, while the latter is awaiting regulatory decisions in China. Both fam-trastuzumab deruxtecan and disitamab vedotin are undergoing studies in cholangiocarcinoma, an indication that currently has no targeted HER2 therapy on the market. HER2-targeted cancer therapies generated USD 11.07 billion in global sales in 2018, with projections indicating that the market could reach USD 15.6 billion by 2024.-Fineline Info & Tech
