What's Happening?
Antengene Corporation Limited presented the latest clinical data for its ATG-022 antibody-drug conjugate (ADC) at the European Society for Medical Oncology Congress 2025. The Phase I/II CLINCH study demonstrated
the efficacy of ATG-022 across all levels of CLDN18.2 expression in patients with advanced gastric and gastroesophageal junction cancer. The study reported an objective response rate of 40% and a disease control rate of 90% in patients with moderate to high CLDN18.2 expression. ATG-022 has been granted Orphan Drug designations by the U.S. FDA for gastric and pancreatic cancer and received Breakthrough Therapy Designation in China.
Why It's Important?
The promising results of ATG-022 highlight its potential as a new treatment option for patients with gastric and gastroesophageal junction cancer, particularly those with CLDN18.2-positive tumors. The drug's efficacy across different expression levels suggests it could benefit a broader patient population. The favorable safety profile supports its use in combination with chemotherapy and immune checkpoint inhibitors, potentially expanding its clinical reach and commercial potential. As cancer remains a leading cause of death worldwide, advancements in targeted therapies like ATG-022 are crucial for improving patient outcomes.
What's Next?
Antengene plans to continue the Phase II dose expansion study of ATG-022 in China and Australia, while preparing for combination therapy studies to further advance its clinical development. The company aims to expand the drug's application to other non-gastrointestinal tumor types, with preliminary efficacy observed in these areas. As the clinical trials progress, Antengene will seek regulatory approvals to bring ATG-022 to market, potentially transforming the treatment landscape for CLDN18.2-positive cancers.
