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百濟神州(688235.SH):將公佈百澤安®3期臨牀試驗RATIONALE-309的更新數據分析

格隆匯4月19日丨百濟神州(688235.SH)公佈,公司將在美國臨牀腫瘤學會(ASCO)全體大會系列會議上公佈3期臨牀試驗RATIONALE-309的更新數據分析。該項試驗旨在研究百澤安®聯合化療對比安慰劑聯合化療作為復發或轉移性鼻咽癌患者的一線治療效果。

百澤安®是一款人源化IgG4抗程序性死亡受體-1(PD-1)單克隆抗體,設計目的是為最大限度地減少與巨噬細胞中的Fcγ受體結合。臨牀前數據表明,巨噬細胞中的Fcγ受體結合之後會激活抗體依賴細胞介導殺傷T細胞,從而降低了PD-1抗體的抗腫瘤活性。百澤安®是第一款由公司的免疫腫瘤生物平台研發的藥物,目前正進行單藥及聯合療法臨牀試驗,以開發一系列針對實體瘤和血液腫瘤的廣泛適應症。

RATIONALE-309是一項多中心、隨機、雙盲、安慰劑對照的3期臨牀試驗(NCT03924986),旨在評估百澤安®聯合吉西他濱和順鉑(A組)對比安慰劑聯合吉西他濱和順鉑(B組)作為復發或轉移性鼻咽癌(RM-NPC)患者一線治療的有效性和安全性。此次更新後的有效性分析表明,在中位隨訪時間為15.5個月時,百澤安®聯合化療相比於單獨化療在RM-NPC患者中仍顯示出具有臨牀意義的無進展生存期(PFS)獲益。百澤安®和化療聯合用藥的安全性特徵總體可控,且與每種治療藥物的已知風險一致。

針對探索性終點還進行了生物標誌物分析(包括PD-L1和基因表達譜[GEP])。百澤安®聯合化療組患者(無論PD-L1狀態)的PFS均有改善。GEP分析鑑定了一組具有“熱”腫瘤免疫特徵的患者,其特徵是最高水平表達免疫細胞,包括T細胞、自然殺傷細胞、樹突狀細胞和抗原呈遞機制。在這組“熱”腫瘤微環境特徵的患者中觀察到百澤安®聯合化療的最大PFS獲益。

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