Henlius Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA

May 8, 2024  Source: drugdu 80

"/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-positive 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. 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%. 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. 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.

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.

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-positive cancer. This includes advancing clinical trials and registrations worldwide for HLX22 to bring hope to more patients around the world.

https://mp.weixin.qq.com/s?__biz=MzI0Mzc1ODA3OA==&mid=2247510573&idx=1&sn=a53c4071ee794ba185b652bbe65fe3e1&chksm=e96accbcde1d45aae7cfc7a98512a7b64b7609d5b33c96f6ccb18156128b14a01a59719e64b1&mpshare=1&scene=1&srcid=05076z6hQNRNpTSqqrNbvrTC&sharer_shareinfo=44dfc007c513217ac3ba9ea8e93bc471&sharer_shareinfo_first=44dfc007c513217ac3ba9ea8e93bc471#rd

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