复宏汉霖抗HER2单抗HLX22国际多中心III期的新药临床试验申请已获得美国FDA许可
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2024年5月6日,复宏汉霖(2696.HK)宣布,公司创新型抗HER2单抗HLX22的国际多中心III期的新药临床试验(IND)申请已经获得美国食品药品监督管理局(FDA)许可,拟用于联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌。目前,全球尚无同类用于治疗H♈ER2阳性胃癌的HER2双靶向疗法获批准𓂃上市。
迄今为止,胃癌/胃食管连接部(G/GEJ)癌依旧构成了一大全球健康问题。据GLOBOCAN数据显示,2022年全球约有100万新发病例[1]。多数G/GEJ癌患者确诊时已处于疾病晚期,总体预后不良,5年生存率仅为6%[2,3],这其中HER2 阳性患者占比约为12%-23%,且其预后较HER2阴性患者更差[2,4]。目前,对于HER2阳性的局部晚期/转移性G/GEJ患者,其标准一线疗法为曲妥珠单抗联用化疗,针对PD-L1 阳性(PD-L1 CPS≥1)的患者,一些指南亦推荐进一步叠加联用免疫治疗,但持续疗效和预后仍有待进一步改善[5]。
HLX22为复宏汉霖自AbClon, Inc.许可引进、并后续自主研发的靶向HER2的创新型单克隆抗体。与曲妥珠单抗类似,HLX22可结合在HER2的亚结构域IV,但结合表位与曲妥珠单抗有所不同,使得HLX22和曲妥珠单抗能够同时与HER2结合,从而产生更强的HER2受体阻断效果。临床前研究表明,HLX22与曲妥珠单抗联合治疗可抑制表皮生长因子(EGF)和HRG1(Histidine-Rich Glycoprotein 1)诱导的细胞增殖,增强体外和体内的抗肿瘤活性。此前,HLX22针对HER2过表达的晚期实体瘤的I期临床研究数据显示,HLX22在HER2过表达的晚期实体瘤患者中具有良好的安全性和耐受性[6]。2024年1月,HLX22联合汉曲优®(曲妥珠单抗,欧洲商品名:Zercepac®)治疗HER2阳性胃癌II期临床研究数据首次发布于2024年美国临床肿瘤学会胃肠道肿瘤研讨会(ASCO GI),该研究结果显示,在HLX02(曲妥珠单抗)联用化疗的基础上加入HLX22可提高HER2阳性G/GEJ癌患者一线治疗的生存期和抗肿瘤反应,且安全性可控[7]。
未来,公司也将继续秉持以♎患者为中心,聚焦未满足的临床需求,积极探索优化HER2阳性肿瘤联合疗法并推进HLX22的更多国际临床注册,为全球更多患者带去福音。
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Henlius Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA
Shanghai, China, May 6, 2024-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved by the United States Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positiv🤪e gastric cancer has received approval for commercialization globally.
Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022 [1]. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6% [2,3]. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease used to be even worse than those with HER2-negative disease -2. Currently, for patients with HER2-positive locally advanced/metastatic G/GEJ cancer, the current standard first-line treatment is trastuzumab plus chemotherapy. Immunotherapies are recommended to be added for tumours with PD-L1 expression levels by CPS (Combined Positive Score) of greater than 1. However, the effectiveness and prognosis for these treatments need to be further improved [5].
HLX22 is an innovative anti-HER2 mAb that was introduced from AbClon, Inc. and further researched and developed by Henlius. HLX22 can bind to HER2 subdomain IV at a different binding site from trastuzumab, which allows the simultaneous binding of HLX22 and trastuzumab to HER2. Pre-clinical studies have showed that the combination therapy of HLX22 and trastuzumab inhibits the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The phase 1 clinical trial of HLX22 demonstrates that HLX22 is well tolerated and has good safety profiles. In January 2024, results from the phase 2 study of HLX22 combined with HANQUYOU (trastuzumab for injection, HLX02, trade name in Europe: Zercepac®) and chemotherapy for the first-line treatment of HER2-positive G/GEJ cancer was first released at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI), which showed that adding HLX22 to HLX02 (trastuzumab for injection) + XELOX improved survival and antitumor response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile [7].
Moving forward, the company will continue to uphold a patient-centric approach, focus on unmet medical needs, and actively explore the optimization of combination therapies for HER2-posit𒊎ive cancer. This includes advancing clinical trials and registrations worldwide for HLX22 to bring hope to more patients around the world.
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