和鉑醫藥-B(02142.HK)公佈新一代抗CTLA-4抗體HBM4003 I期研究的積極結果與數據摘要
格隆匯9月13日丨和鉑醫藥-B(02142.HK)宣佈，集團在澳大利亞進行的實體瘤HBM4003的I期劑量爬坡臨牀試驗(“I期研究”)取得積極結果。臨牀數據摘要已於2021年歐洲腫瘤內科學會(ESMO)年會上以電子海報形式發佈。
於I期研究獲取的數據乃新一代抗CTLA-4全人源單克隆僅重鏈抗體(HCAb)應用於實體瘤的首例臨牀實證，數據顯示HBM4003療效令人鼓舞，並具有良好的安全特性。於I期研究中的所有療法不良相關事件(TRAEs)均為可控和可逆。HBM4003單一療法的初始抗腫瘤功效令人鼓舞，尤其是兩名經歷多線治療的受試者對HBM4003單藥治療產生了應答，其中一名晚期肝癌患者之前還接受了PD-1治療。
I期研究設計
I期研究是一項在晚期實體瘤受試者中進行的開放標籤、多中心研究，受試者接受HBM4003治療劑量水平分別為0.3mg/kg QW(28天週期)、0.45mg/kg Q3W(21天週期)和0.6mg/kg Q3W(21天週期)。劑量爬坡階段的主要終點為發生劑量限制性毒性的患者比例。
I期研究的主要結果
I期研究的主要結果包括：
(i) 於開展I期研究的四個澳大利亞研究中心，已有20名晚期實體腫瘤患者接受治療，20名患者中有13名(65%)患者曾接受過兩種或兩種以上的先前治療方案。8名(40%)患者接受過PD-1治療。
(ii) HBM4003療法顯示出良好的安全性。並無發現與肺、腎、心臟或內分泌系統相關的毒性。
(iii) 推薦使用0.45 mg/kg Q3W作為II期劑量進行劑量擴增。
(iv) 共有15名患者進行了治療後腫瘤評估。已確認一名肝細胞癌(HCC)患者發生部分緩解(PR)，另有一名前列腺癌患者獲得PSA反應，同時腫瘤在長達24周內保持SD。9名患者病情穩定(SD)，其中3名患者腫瘤縮小。
(v) 對於病情得到部分緩解的肝細胞癌患者，在停止治療後觀察到臨牀獲益延長。目標病灶的腫瘤減少達64.4%，且於末次給藥後16周不再檢測到非目標病灶。
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