李氏大藥廠(00950.HK)：PD-L1抗體用於骨肉瘤維持治療的III期臨牀試驗已成功開展患者招募工作並已完成首例患者給藥
格隆匯 8 月 21日丨李氏大藥廠(00950.HK)宣佈，集團的附屬公司中國腫瘤醫療有限公司("COF")於一項使用ZKAB001(抗PD-L1單克隆抗體)的骨肉瘤維持治療III期臨牀試驗已成功開展患者招募工作並已於2020年8月21日完成首例患者給藥。
骨肉瘤是兒童和青少年最常見的惡性骨腫瘤。一般而言，由外科手術配合至少三種化藥的化學療法治療可將局部疾病患者的長期生存率提高約70％。但是，有一大部分經過上述治療而得到疾病完全緩解的患者仍會復發，而復發後的存活機率要低很多(約20％)。
ZKAB001是針對腫瘤PD-L1蛋白的完全人類抗PD-L1單克隆抗體。它可以釋放由腫瘤細胞引起的免疫系統"剎車"。公司今年初已完成了一項使用ZKAB001治療接受過前期治療的骨肉瘤患者的I期臨牀試驗，評估ZKAB001是否能預防腫瘤復發，該試驗取得令人鼓舞的結果促成了開展這一項命名為"高級別骨肉瘤患者輔助化療後以ZKAB001進行維持治療的研究"的III期臨牀實驗。該試驗共有34家研究中心參與，預計包括安慰劑組在內一共入組362名患者。患者會接受每三週一次的ZKAB001治療，最多16個週期或一年的治療，以先到者為準。這臨牀試驗的主要終點為一年無疾病生存期。
據悉，COF於2015年創立，為李氏大藥廠的附屬公司，負責進行以免疫腫瘤學為重點的腫瘤學臨牀開發程式。COF現正開發多項資產，包括Pexa-vec(一種溶瘤病毒，處於腎細胞癌全球第Ib期臨牀試驗)；ZKAB001(一種PD-L1抑制劑，在中國處於實體瘤(是一項高度未獲滿足的醫療需求)第I期臨牀試驗劑量擴展階段)；Zotiraciclib(一種口服多靶點激酶抑制劑，初步治療對象為膠質母細胞瘤及肝細胞癌)；及吉馬替康(一種拓撲異構酶I抑制劑，在中國處於卵巢癌第I期臨牀試驗及小細胞肺癌第Ib/II期臨牀試驗)。COF已通過內部研發及從外引進的方式建立涵蓋10項資產的強大管道。COF的產品多樣化，讓集團獨佔鰲頭，以免疫腫瘤治療為骨幹，結合自行研發的產品，開發改進的癌症療法。
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