Recently, Henlius successfully hosted an in-person clinical investigator meeting for the HLX22-GC-301 study in Rio de Janeiro, Brazil. The meeting focused on the international phase 3 clinical trial (HLX22-GC-301) of HLX22, our innovative anti-HER2 monoclonal antibody (mAb), in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer. The meeting brought together over 65 leading oncologists and clinical researchers from more than 35 clinical sites in Brazil, Argentina, Chile, Peru and other countries and regions. Together, they explored the clinical advantages of HLX22 as a potential Best-in-Class candidate and discussed strategies for its development in LATAM. The HLX22-GC-301 study, co-led by Dr. Lin Shen of Peking University Cancer Hospital and Dr. Jaffer A. Ajani (MD Anderson Cancer Centre; Chair of the NCCN Guidelines Panel for Gastric and Esophageal Cancers), has already been approved and initiated in China, the U.S., Japan, Australia, Argentina and other countries and regions.
Gastric cancer is a highly prevalent malignancy in Latin America. According to the latest GLOBOCAN data, gastric cancer mortality ranked 6th among all cancer types in Latin America[1].Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6% [2,3]. Despite the advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1/PD-L1 mAbs) for gastric cancer treatment in recent years [4], the disease's high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes [5]. Immunotherapy remains limited to PD-L1 positive populations with only modest efficacy improvements. This underscores the urgent unmet clinical needs in the overall management of HER2 positive gastric cancer.
HLX22 is a differentiated HER2-targeting monoclonal antibody that binds to a novel epitope on the HER2 extracellular domain. It can bind HER2 simultaneously with trastuzumab, effectively promoting internalization and degradation of HER2 homodimers and HER2/EGFR heterodimers. Preclinical studies demonstrated HLX22 increases HER2 internalization efficiency by 40–80%, leading to stronger HER2 blockade. Importantly, HLX22-GC-301 does not limit enrolment by PD-L1 status, aiming to overcome clinical limitations of current first-line treatment for HER2-positive gastric cancer.HLX22-GC-301 is a randomized, double-blind, international Phase 3 trial directly comparing HLX22 in combination with trastuzumab and chemotherapy versus the current first-line standard of care (trastuzumab + chemotherapy ± pembrolizumab) for HER2-positive advanced gastric cancer,aiming to compare the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive, locally advanced or metastatic gastroesophageal junction cancer and gastric cancer.
Professor Lin Shen, principal investigator of the study from Peking University Cancer Hospital, said:" Henlius' HLX22 is a highly promising HER2-targeted therapy distinguished by both its mechanism of action and clinical performance. Its differentiated molecular design enables simultaneous binding to HER2 alongside trastuzumab, demonstrating exceptional antitumor efficacy. The initiation of this study in Latin America holds substantial importance in addressing the region's high incidence of gastric cancer. We will collaborate closely with all participating research centers to advance the clinical development of this therapy."
Dr. Juan Pablo Miranda Olivares of the RedSalud Cancer Institute in Chile stated: "During this investigator meeting, the interpretation of the HLX22-GC-301 study protocol and clarification of the regulatory requirements were particularly insightful, which lays a solid foundation for high-quality implementation in the following phases. We look forward to continuing our close collaboration with the Henlius team to jointly advance the progress of this study."
Dr. Manuel Philco of the Peruvian Institute of Oncology and Radiotherapy in Peru remarked: "As a key research center in the region, we have a deep understanding of the urgent needs of local gastric cancer patients. This investigator meeting has helped us clarify the critical details of the study protocol, and we are committed to promoting the smooth conduct of the clinical trial in Peru, enabling innovative therapies to benefit patients as soon as possible."
Dr. Susana Kahl of the Pergamino Research Center in Argentina noted: "The professionalism and enthusiasm demonstrated by all participating researchers were truly impressive. Through in-depth communication with the Henlius team, we gained a better understanding of the clinical value of the innovative therapy in this trial. We look forward to providing new treatment options for gastric cancer patients in Argentina and across Latin America through rigorous clinical research."
Gary Yu, Deputy General Manager of Clinical Operations at Henlius, shared the company’s broader expectations for the study: " HLX22 is a key global innovative drug project that the company is focusing on. Previously, the first patient in Latin America was administered the drug in Argentina, marking a new stage in the global clinical development of Henlius. We look forward to accelerating clinical research through close cooperation with local research institutions and bringing new treatment hope to more patients as soon as possible."
The investigator meeting facilitated in-depth discussions that further clarified patient management practices, diagnostic and treatment standards, as well as clinical trial protocol in Latin America, laying a solid foundation for the high-quality execution of the study. Looking forward, Henlius will remain committed to our mission of " To improve patients' lives by timely providing them with quality and affordable protein therapeutics through technical innovation and operational excellence. " The company will accelerate the global clinical development of innovative therapeutics, including HLX22, to provide new treatment options for patients with gastric cancer globally.
【Reference】
[1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35.
[2] Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92.
[3] Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70.
[4] Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022).
[5] Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023).
[6] Jin Li et al. HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients.. JCO 43, 440-440(2025). DOI:10.1200/JCO.2025.43.4_suppl.440
About HLX22
HLX22, a monoclonal antibody targeting a novel epitope of HER2, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, resulting in a 40%–80% increase in HER2 internalisation. Updated results from a phase 2 study (HLX22-GC-201) of HLX22 in combination with HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer were presented at ASCO 2025 [6]. The data demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with extended follow-up (median follow-up exceeding two years), outperforming previous data.