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百濟神州(06160.HK):百澤安聯合化療用於一線治療胃或胃食管結合部癌的3期臨牀試驗取得積極結果
格隆匯 01-24 20:34

格隆匯1月24日丨百濟神州(06160.HK)公吿,百澤安聯合化療對比安慰劑聯合化療用於一線治療局部晚期、不可切除或轉移性胃或胃食管結合部(G/GEJ)腺癌患者的全球3期臨牀試驗RATIONALE 305取得積極結果。在期中分析中,百澤安聯合化療在表達PD-L1的患者中達到了總生存期(OS)的主要終點,需進一步隨訪以評估意向治療患者人羣(ITT)的總生存期獲益。百澤安的安全性結果與此前試驗中的觀察一致,與化療聯用未出現新的安全性警示。

百濟神州實體瘤首席醫學官賁勇醫學博士表示:“百澤安聯合化療顯着延長了表達PD-L1的既往未經治療的晚期或轉移性胃或胃食管結合部腺癌患者的總生存期。公司將繼續隨訪以確認其在參與試驗的患者人羣中的總生存期獲益”。

據悉,RATIONALE 305是一項比較百澤安?聯合鉑類藥物和氟尿嘧啶化療與安慰劑聯合鉑類藥物和氟尿嘧啶化療用於一線治療局部晚期、不可切除或轉移性G/GEJ腺癌患者的療效和安全性的隨機、雙盲、安慰劑對照全球3期臨牀試驗(NCT03777657)。本試驗的主要終點為OS,次要終點包括無進展生存期(PFS)、總緩解率(ORR)、緩解持續時間(DoR)和安全性。該臨牀試驗在全球13個國家及地區共入組了997例患者,其中近半數來自中國以外的地區,入組患者以1:1的比例隨機接受百澤安?聯合化療或安慰劑聯合化療的治療。

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