中國生物製藥(01177.HK)：FS222"CD137/PD-L1"I期陽性臨牀數據在2024ASCO公佈
格隆匯6月5日丨中國生物製藥(01177.HK)公吿，公司全資附屬公司invoX Pharma Limited("invoX")已在2024年美國臨牀腫瘤學會(ASCO)年會上以口頭報吿的形式公佈了FS222"CD137/PD-L1"正在進行的I期臨牀試驗的最新成果，用於晚期實體瘤患者。數據顯示，其在多種腫瘤類型中，均展現出了強大的抗腫瘤活性，且安全性可控。
FS222是一種新型的四價雙特異性抗體，通過利用invoX專有的Fcab®平台技術，來驅動PD-L1依賴的CD137的激動作用。此次公佈的數據來自於正在晚期實體瘤患者中進行的FS222首次人體、劑量遞增的I期臨牀試驗(NCT04740424)，共100例受試者。本研究旨在評估藥物的安全性並確定最大耐受劑量，次要目的包括評估抗腫瘤活性、藥代動力學和藥效學。
作為每4周給藥一次的單藥治療，FS222在廣泛的劑量範圍內增加了T細胞增殖和腫瘤內CD8+T細胞浸潤。治療相關不良事件(TRAE)的發生率普遍呈劑量依賴性。總體而言，TRAE與預期的CD137激動和PD-L1阻斷雙重作用機制一致，並且通常是可控和可逆的。36/100例受試者發生≥3級TRAE，最常見的包括天門冬氨酸氨基轉移酶和丙氨酸氨基轉移酶升高、血小板減少、中性粒細胞減少和發熱性中性粒細胞減少。
在研究中，FS222在多種腫瘤類型中展現出了強大的抗腫瘤活性。在皮膚黑色素瘤(n=9)、卵巢癌(n=2)、非小細胞肺癌(NSCLC)(n=2)以及粘膜黑色素瘤、三陰性乳腺癌(TNBC)、間皮瘤和MSS型結直腸癌(各1例)中觀察到緩解(根據RECIST1.1標準定義)。研究中所有患者的疾病控制率(定義為完全緩解率、部分緩解率和疾病穩定率的總和)為45.0%。
在19例既往接受過PD-1抗體治療的轉移性╱晚期皮膚黑色素瘤患者中，總緩解率(定義為完全緩解和部分緩解比例和)為47.4%，疾病控制率為68.4%。
FS222的I期臨牀試驗正在招募受試者，該研究正在進一步探索FS222的劑量優化。此次數據不僅展示出了FS222在多種腫瘤類型中強大的抗腫瘤活性，也為invoX的抗體平台提供了重要驗證。本集團將加速FS222的臨牀開發，並繼續利用集團專有的抗體平台開發更多的藥物。
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