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微芯生物(688321.SH):西達本胺一線治療瀰漫大B細胞淋巴瘤的III期臨牀試驗獲得頂線分析數據
格隆匯 07-09 16:01

格隆匯7月9日丨微芯生物(688321.SH)公佈,自主研發的西達本胺針對一線治療瀰漫大B細胞淋巴瘤(DLBCL)關鍵性III期臨牀試驗(DEB研究)已於近日獲得最終結果的頂線分析數據,試驗組無事件生存期(EFS)顯著優於對照組,達成研究主要終點。

西達本胺聯合R-CHOP(CR-CHOP)是全球首個在III期臨牀中完全緩解(CR)率顯著優於R-CHOP的一線DLBCL治療方案。此次頂線分析中,試驗組無事件生存期(EFS)較對照組展現具統計學顯著意義的差異,進一步驗證了西達本胺聯合方案可為初治MYC和BCL2雙表達DLBCL患者帶來顯著且可持續的療效,且安全性良好。公司正在準備該適應症常規批准的申報。同時,該研究最終結果的全面分析也將於後續學術會議或期刊中呈現。

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