復宏漢霖(02696.HK)：HLX22聯合德曲妥珠單抗治療局部晚期或轉移性乳腺癌的2期臨牀研究於中國大陸完成首例患者給藥
格隆匯4月17日丨復宏漢霖(02696.HK)宣佈，近日，一項HLX22(重組人源化抗HER2單克隆抗體注射液)("HLX22")聯合德曲妥珠單抗治療HER2低表達HR陽性的局部晚期或轉移性乳腺癌的2期臨牀研究於中國大陸完成首例患者給藥。
臨牀試驗設計及目的
本研究是一項多中心的2期臨牀研究，旨在評估HLX22聯合德曲妥珠單抗治療經標準治療後疾病進展或不可耐受毒性反應的，HER2低表達HR陽性的局部晚期或轉移性乳腺癌患者的療效和安全性。符合條件的受試者將接受HLX22(15mg/kg，靜脈注射)聯合德曲妥珠單抗(5.4mg/kg，靜脈注射)治療。該研究的主要終點爲獨立影像評估委員會(IRRC)基於RECIST v1.1評估的客觀緩解率(ORR)和無進展生存期(PFS)；次要終點包括研究者評估的客觀緩解率(ORR)和無進展生存期(PFS)、總生存期(OS)、獨立影像評估委員會(IRRC)及研究者評估的緩解持續時間(DOR)、安全性、藥代動力學、免疫原性和生物標誌物。
HLX22爲公司許可引進並後續自主研發的新型靶向HER2的單克隆抗體，潛在適應症包括胃癌和乳腺癌等實體瘤。2025年3月，HLX22用於治療胃癌(GC)獲美國食品藥品監督管理局(FDA)孤兒藥資格認定(Orphan-drugDesignation)。
德曲妥珠單抗(T-DXd)是一種靶向HER2的抗體偶聯藥物("ADC")，已在中、美、歐等國家和地區上市。HLX22聯合德曲妥珠單抗的臨牀前動物試驗顯示，該治療策略具有協同抗腫瘤作用和良好的安全性。因此，HLX22聯合德曲妥珠單抗是另一值得探索的HER2靶向治療新策略，有望爲HER2表達腫瘤患者帶來更多獲益。
根據IQVIA CHPA的數據(IQVIA是全球醫藥健康產業專業信息和戰略諮詢服務提供商)，2024年度，靶向HER2的單抗產品於中國大陸的銷售金額約爲人民幣97.86億元。目前，於全球範圍內尚無「抗HER2單抗+靶向HER2的ADC」的聯合治療方案獲批上市。
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