Shanghai Henlius Biotech presented new clinical data on its anti-PD-1 antibody, serplulimab (HANSIZHUANG), and its anti-HER2 antibody, HLX22, at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco. The data, presented in poster sessions, highlighted the potential of these agents in treating various gastrointestinal cancers.
Serplulimab in Metastatic Colorectal Cancer
Updated efficacy and subgroup analysis were presented from a Phase 2/3 study of first-line serplulimab plus bevacizumab and XELOX (capecitabine and oxaliplatin) versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer. The study, led by Rui-Hua Xu from Sun Yat-sen University Cancer Center, suggests a potential benefit for the serplulimab combination in this setting. The presentation number was 170, and the poster was displayed on January 25, 2025.
Perioperative PD-1 Inhibitor in Gastric Cancer
A single-center retrospective cohort study, led by Yian Du from Zhejiang Cancer Hospital, investigated the safety and efficacy of perioperative chemotherapy combined with a PD-1 inhibitor versus chemotherapy alone with D2 gastrectomy plus para-aortic node dissection (PAND) in gastric cancer patients with para-aortic lymph node (PALD) metastasis. The findings suggest that adding a PD-1 inhibitor to perioperative chemotherapy may improve outcomes in this patient population. The poster presentation number was 368, displayed on January 23, 2025.
HLX22 in HER2-Positive Gastric/Gastroesophageal Junction Cancer
Updated results from a Phase 2 study (HLX22-GC-201) evaluating HLX22 in combination with trastuzumab (HLX02) and XELOX as first-line therapy for HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC) were presented. The data, with additional patients, continue to show that the addition of HLX22 to trastuzumab plus chemotherapy improves efficacy with manageable safety. The study was led by Jin Li from Shanghai GoBroad Cancer Hospital. The poster presentation number was 440, displayed on January 23, 2025. Previous results from this study were presented at the 2024 ASCO GI, 2024 ESMO GI, and published in Med.
HLX22, an innovative anti-HER2 mAb, binds to HER2 subdomain IV, a different site than trastuzumab, allowing simultaneous binding of both antibodies. Pre-clinical studies have shown that this combination inhibits cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1), enhancing antitumor activity. A Phase 1 clinical trial demonstrated that HLX22 is well-tolerated with a good safety profile.
Serplulimab is Henlius’ first self-developed innovative anti-PD-1 mAb and is approved in China and several Southeast Asian countries for various indications, including extensive-stage small cell lung cancer (ES-SCLC), squamous non-small cell lung cancer (sqNSCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). The marketing application for first-line treatment of ES-SCLC is under review by the European Medicines Agency (EMA).
