The 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) is scheduled from June 26 to June 29 in Munich, Germany. Henlius will present the latest clinical data from its phase 2 study (HLX22-GC-201) of HLX22, a novel anti-HER2 monoclonal antibody, combined with HANQUYOU (trastuzumab, HLX02) and chemotherapy for the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer. Professor Jin Li of Shanghai East Hospital, School of Medicine, Tongji University, is the leading principal investigator of this study.
Initial results from HLX22-GC-201, first released at the 2024 ASCO Gastrointestinal Cancers Symposium, indicated that adding HLX22 to HLX02 and chemotherapy extended progression-free survival and improved antitumour response in patients with HER2-positive G/GEJ cancer, with a manageable safety profile.
At the 2024 ESMO GI, Henlius will present updated results from the HLX22-GC-201 study under the title "HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: updated results from a randomized, double-blind phase 2 study" (Abstract Number: 422P). The poster display session is scheduled for June 27, 2024, from 3:35 PM to 4:30 PM GMT+2.
G/GEJ cancer remains a significant global health challenge, with approximately 1 million new cases reported in 2022. The disease often carries a poor prognosis due to late-stage diagnosis, with a 5-year relative survival rate of only 6%. HER2 positivity in gastric cancer patients ranges from 12% to 23%, and the prognosis for HER2-positive disease is worse than for HER2-negative disease. Current standard first-line treatment for HER2-positive locally advanced/metastatic G/GEJ cancer involves trastuzumab plus chemotherapy, with immunotherapies recommended for tumors with PD-L1 expression levels by combined positive score greater than 1. However, the sustained efficacy and prognosis of these treatments require further improvement.
HLX22, an innovative anti-HER2 monoclonal antibody developed by Henlius, binds to HER2 subdomain IV at a different site from trastuzumab, allowing simultaneous binding of both antibodies to HER2. Pre-clinical studies have demonstrated that the combination of HLX22 and trastuzumab inhibits cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1), enhancing antitumour activity both in vitro and in vivo. The phase 1 clinical trial of HLX22 confirmed its good tolerability and safety profiles. The United States Food and Drug Administration (FDA) has recently approved the investigational new drug application (IND) for a phase 3 international multicenter clinical study of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer.
Henlius remains committed to addressing patient needs and developing innovative, high-quality solutions and services for patients worldwide.
