百濟神州(06160.HK):百澤安®治療非小細胞肺癌的RATIONALE 303臨試在中期分析中達到總生存期主要終點
格隆匯 11 月 18日丨百濟神州(06160.HK)發佈公告,公司於2020年11月17日宣佈經獨立數據監查委員會(DMC)判斷,在其用於評估抗PD-1抗體百澤安®對比多西他賽針對接受鉑類化療後出現疾病進展的二線或三線局部晚期或轉移性非小細胞肺癌(NSCLC)患者的RATIONALE 303臨牀試驗的事先計劃的中期分析中,在意向治療患者人羣中達到了總生存期(OS)這一主要終點。百澤安®的安全性數據與已知風險相符,未出現新的安全警示。
百濟神州腫瘤免疫學首席醫學官賁勇醫學博士評論道:“RATIONALE 303是第三項針對非小細胞肺癌在中期分析中達到主要終點的百澤安®3期臨牀試驗,也是百澤安®臨牀項目中第一項取得積極結果的全球關鍵性臨牀試驗,有力地證明了百濟神州不斷擴展的全球臨牀開發能力。我們期待在接下來的一場醫學會議上公佈該項試驗的完整數據,也希望在未來能夠繼續向大家帶來百澤安®肺癌項目的進展。”賁勇醫學博士補充道:“隨着百澤安®針對一系列高發癌症的廣泛臨牀項目在全球範圍內不斷推進,我們期待能夠不斷充實這款潛在差異化檢查點抑制劑的相關臨牀證據,對其進行更加深入的評估並支援其在中國和全球各地的藥政註冊。”
根據披露,RATIONALE 303是一項隨機、開放性、多中心的全球3期臨牀試驗(NCT03358875),旨在評估百澤安®對比多西他賽用於治療接受鉑類化療後出現疾病進展的二線或三線局部晚期或轉移性NSCLC患者的有效性和安全性。該試驗的主要終點為在全部患者(意向治療患者人羣)中以及在PD-L1高表達患者中的OS;關鍵次要終點包括客觀緩解率(ORR)、緩解持續時間(DoR)、無進展生存期(PFS)及安全性。該試驗共在10個國家入組了805例患者,以2:1的比例隨機至百澤安®試驗臂或多西他賽試驗臂。
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