ASCO GI 2026 | 复宏汉霖抗HER2单抗HLX22一线治疗HER2阳性胃癌的III期国际多中心头对头研究加速推进

HLX22为靶向HER2的创新型单克隆抗体，可结合在HER2的胞外亚结构域IV，但结合表位与曲妥珠单抗有所不同，使得该产品能够与曲妥珠单抗同时结合至HER2，有效促进HER2二聚体（HER2同源二聚体及HER2/EGFR异源二聚体）的内吞和降解，将HER2的内吞效率提高了40%-80%，进而产生更强的HER2受体阻断效果。

此前，复宏汉霖已开展一项HLX22联合汉曲优^®（曲妥珠单抗，美国商品名：HERCESSI^™️，欧洲商品名：Zercepac^®）治疗HER2阳性胃癌的II期临床研究（HLX22-GC-201）并公布阶段性结果。研究显示，经过长期随访（中位随访周期超2年），HLX22联合方案在HER2阳性胃癌治疗中依然展现出稳定的疗效获益，明显延长OS（中位总生存期 [mOS]：未达到 [95% CI: 16.2, NE] vs. 16.4个月 [95% CI: 10.7, NE]；HR=0.6 [95% CI:0.28,1.21]）和PFS（中位无进展生存期 [mPFS]：未达到 [95% CI: 16.2, NE] vs. 8.3个月 [95% CI: 5.7, 21.4]；HR=0.2 [95% CI:0.09,0.54])，疾病进展和死亡风险降低80%，远超历史数据，为 HLX22-GC-301头对头研究的设计与实施提供了重要依据。

本次发布的HLX22-GC-301为一项随机、双盲、国际多中心 III 期临床研究，旨在头对头比较HLX22联合曲妥珠单抗及化疗与当前一线标准疗法（曲妥珠单抗+化疗±帕博利珠单抗）在HER2阳性局部晚期或转移性GC/GEJC患者中的疗效与安全性。HLX22-GC-301关键入选标准包括经组织学或细胞学确诊、既往未接受治疗的局部晚期不可切除或转移性、HER2阳性G/GEJ腺癌；关键排除标准包括既往接受过任何HER2靶向治疗。研究计划从全球多个地区入组约550例患者，按1:1随机分配接受以下治疗：HLX22（15 mg/kg）联合曲妥珠单抗及XELOX±帕博利珠单抗安慰剂，或HLX22安慰剂联合曲妥珠单抗及XELOX±帕博利珠单抗。HLX22的给药在每个21天的治疗周期的第1天通过静脉输注进行，持续给药至失去临床获益、死亡、出现不可耐受毒性、撤回知情同意或其他原因终止。分层因素包括HER2免疫组化评分（3+相比2+）、地理区域（亚洲相比欧洲/北美相比其他地区）、肿瘤原发部位（胃相比胃食管结合部）及肿瘤PD-L1表达（CPS <1或不可评估相比1≤CPS<10相比CPS≥10）。共同主要终点为独立影像评估委员会基于实体瘤疗效评价标准（RECIST v1.1）评估的无进展生存期（PFS），以及总生存期（OS）；次要终点包括研究者评估的PFS、客观缓解率、后续治疗线的PFS、持续缓解时间、安全性、药代动力学、免疫原性及生活质量。

基于其在胃癌领域的临床开发潜力，HLX22于2025年先后获得美国食品药品监督管理局（FDA）和欧盟委员会（EC）授予的孤儿药资格认定（ODD），用于胃癌的治疗。继HER2阳性胃癌之后，HLX22的临床研究布局已进一步拓展至乳腺癌领域。2025 年，HLX22联合德曲妥珠单抗治疗HER2表达乳腺癌的II期临床研究在中国完成首例患者给药，相关临床前及早期研究结果显示，该联合方案具备协同抗肿瘤作用和良好的安全性特征，有望为更多 HER2 驱动型肿瘤患者带来新的治疗选择。

未来，复宏汉霖将持续推进 HLX22 的全球临床开发进程，系统探索新型抗 HER2 靶向治疗在多瘤种中的应用潜力，为全球患者提供更多可负担、可及性更高的创新治疗方案。

ASCO GI 2026 | Henlius Accelerates Global Phase 3 Head-to-Head Development of HLX22 as First-Line Treatment for HER2-Positive Gastric Cancer

At the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026), Henlius announced the presentation of the trial design for HLX22-GC-301, a international, randomised, double-blind, multicentre phase 3 head-to-head study evaluating HLX22, a novel epitope-targeting anti-HER2 monoclonal antibody, as a first-line treatment for patients with HER2-positive advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC). The trial design was presented in a poster session at the meeting.

The trial is 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). The trial has already been approved and initiated in China, the U.S., Japan, Australia, Argentina, and other countries and regions. Importantly, the trial does not restrict enrolment based on PD-L1 expression status, and is aimed to support the continued evolution of global first-line treatment strategies for HER2-positive gastric cancer. 

HLX22, an innovative anti-HER2 mAb, 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.

Prior to the initiation of the phase 3 trial, Henlius conducted a phase 2 clinical study (HLX22-GC-201) evaluating HLX22 in combination with HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) in patients with HER2-positive gastric cancer, with interim results previously reported. With long-term follow-up exceeding two years, the study showed that the HLX22-based combination demonstrated sustained clinical benefit in patients with HER2-positive gastric cancer, with favourable trends observed in both overall survival (OS) and progression-free survival (PFS).

Median OS was not reached (95% CI: 16.2, NE) compared with 16.4 months (95% CI: 10.7, NE) in the control group (HR = 0.60; 95% CI: 0.28–1.21). Median PFS was not reached (95% CI: 16.2, NE) versus 8.3 months (95% CI: 5.7–21.4), respectively (HR=0.20; 95% CI: 0.09–0.54). These results indicate an 80% reduction in the risk of disease progression or death, substantially exceeding historical trials, and provided important support for the design and implementation of the phase 3 head-to-head HLX22-GC-301 study.

HLX22-GC-301 is a randomized, double-blinded, two-arm international phase 3 clinical study aims to compare the efficacy and safety of HLX22 in combination with trastuzumab and XELOX versus trastuzumab and XELOX with or without (±) pembrolizumab in patients with HER2-positive, advanced G/GEJ cancer and no prior antitumor therapy in the advanced setting. The study’s key inclusion criteria include histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive G/GEJ adenocarcinoma. Key exclusion criteria include prior use of any HER2-target therapy. Approximately 550 eligible patients will be enrolled from multiple regions across the globe and randomly assigned in a 1:1 ratio to receive HLX22 (15 mg/kg) + trastuzumab + XELOX ± placebo (for pembrolizumab) or placebo (for HLX22) + trastuzumab + XELOX ± pembrolizumab. HLX22 will be administered intravenously on Day 1 of each 21-day treatment cycle until loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons. The stratification factors include HER2 immunohistochemistry (3+ vs 2+), geographic region (Asia vs Europe/North America vs rest of the world), primary tumour site (gastric vs gastroesophageal junction), and tumour PD-L1 expression (CPS < 1 or not evaluable vs 1 ≤ CPS < 10 vs CPS ≥ 10). The dual primary endpoints are PFS assessed by independent radiology review committee per RECIST v1.1 and overall survival. Secondary endpoints include investigator-assessed PFS, objective response rate, PFS on the subsequent line of therapy, duration of response, safety, pharmacokinetics, immunogenicity, and quality of life.

In recognition of its potential, HLX22 has been granted Orphan Drug Designation (ODD) for gastric cancer by both the U.S. FDA and the European Commission in 2025, highlighting its global development prospects and clinical value. Beyond gastric cancer, Henlius has also recently initiated a phase 2 clinical trial (HLX22-BC201) of HLX22 in combination with trastuzumab deruxtecan (T-DXd) as second-line therapy for HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer and has dosed the first patient in China. Moving forward, Henlius will continue to explore the therapeutic potential of novel HER2-targeted therapies in tumours, accelerating HLX22’s global development to deliver more affordable and effective treatment options for patients worldwide.

媒体：PR@Henlius.com

投资者：IR@Henlius.com