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百濟神州公佈百澤安®(替雷利珠單抗注射液)聯合化療治療一線非鱗狀非小細胞肺癌患者的3期臨牀試驗中期分析達到無進展生存期的主要終點
格隆匯 04-14 10:38

百濟神州(06160.HK/BGNE.O)是一家處於商業階段的生物科技公司,專注於用於癌症治療的創新型分子靶向和腫瘤免疫藥物的開發和商業化。公司於2020年4月14日宣佈,其抗PD-1抗體百澤安®(替雷利珠單抗注射液)聯合培美曲塞及鉑類化療藥物用於治療一線非鱗狀非小細胞肺癌(NSCLC)患者的3期臨牀試驗在計劃的中期分析中,經獨立評審委員會(IRC)評估達到主要終點,即與僅用培美曲塞和鉑類藥物相比,無進展生存期(PFS)取得了統計顯著性的提高。百澤安®與培美曲塞以及鉑類藥物聯合用藥的安全性數據與每項試驗用藥的已知風險相符,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:“我們非常高興繼今年初公佈的百澤安®在一線鱗狀非小細胞肺癌3期臨牀試驗中期分析的陽性結果後,在此公佈此項百澤安®用於治療一線非鱗狀非小細胞肺癌患者的3期臨牀試驗的中期分析中取得的陽性結果。這些結果進一步證實百澤安®在治療晚期癌症中所展示的有效性和安全性。我們將繼續在包括15項潛在註冊性試驗在內的25項臨牀試驗中對百澤安®進行評估。”

百濟神州計劃於近期啟動與國家藥品監督管理局(NMPA)藥品審評中心(CDE)有關遞交百澤安®用於治療一線非鱗狀NSCLC患者新適應症上市申請(sNDA)的討論,並在未來的學術會議上分享具體的試驗數據。

這是一項開放性、多中心的隨機3期臨牀試驗(clinicaltrials.gov登記號:NCT03663205;又稱BGB-A317-304),用於評估百澤安®(每三週一次、每次劑量為200mg的給藥)聯合培美曲塞及由研究者決定選用的鉑類化療藥物(卡鉑或順鉑),對比僅用培美曲塞與鉑類化療藥物,治療未經系統治療的且不攜帶EGFR突變或ALK易位的IIIB期或IV期非鱗狀NSCLC患者。本項試驗的主要終點為IRC評估的PFS,關鍵次要終點包括總生存期以及安全性。該試驗於2018年7月開始進行患者入組,共有334例患者按2:1的隨機比例接受了百澤安®聯合化療或是僅用化療的治療。

上海交通大學附屬胸科醫院腫瘤科主任兼該項試驗主要研究者陸舜教授表示:“非小細胞肺癌是一種非常惡性的腫瘤,約佔全世界所有肺癌病例的85%。據估計,約有60%肺癌患者在確診時已處於疾病晚期,患者需要更多的治療選擇。百澤安®在這項試驗以及在其他臨牀試驗包括針對一線鱗狀非小細胞肺癌的試驗中,都展示了其有望成為晚期癌症患者的非常有前景的治療方案。”

來源:百濟神州

原標題:百濟神州公佈百澤安®(替雷利珠單抗注射液)聯合化療治療一線非鱗狀非小細胞肺癌患者的3期臨牀試驗中期分析達到無進展生存期的主要終點

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