信達生物(01801.HK)治療肺癌藥物III期臨牀研究達主要研究終點
信達生物(01801.HK)公佈,與禮來製藥聯合開發的創新藥物PD-1抑制劑達伯舒(信迪利單抗注射液)聯合達攸同(貝伐珠單抗注射液),及化療用於表皮生長因子受體酪氨酸激(酉每)抑制劑(EGFR-TKI)治療失敗的EGFR突變非鱗狀非小細胞肺癌(nsqNSCLC)的一項隨機、雙盲、多中心III期臨牀研究(研究代號:ORIENT-31),第一次期中分析達到主要研究終點。
在意向治療(ITT)人羣中,基於盲態獨立影像評估委員會(BIRRC)評估,達伯舒(信迪利單抗注射液)聯合達攸同(貝伐珠單抗注射液)及化療,對比化療獲得顯着且具有臨牀意義的無進展生存期(PFS)延長,達到預設的優效性標準。達伯舒(信迪利單抗注射液)聯合化療對比化療數據尚未成熟,顯示PFS獲益趨勢。
此外,在預設的無效性分析中,達伯舒(信迪利單抗注射液)聯合達攸同(貝伐珠單抗注射液)及化療對比達伯舒(信迪利單抗注射液)聯合化療未穿越無效性界值,達伯舒(信迪利單抗注射液)聯合化療基礎上疊加達攸同(貝伐珠單抗注射液)可以觀察到PFS數值上的提升。安全性特徵與既往報道的達伯舒(信迪利單抗注射液)、達攸同(貝伐珠單抗注射液)相關臨牀研究結果一致,無新的安全性信號。具體ORIENT-31研究結果將在未來的國際學術會議上予以公佈。
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