康寧傑瑞製藥-B(09966.HK)「KN046」抗體三期臨床完成首次期中分析 達預設PFS終點
康寧傑瑞製藥-B(09966.HK)公布,KN046的III期臨床試驗已完成第一次期中分析,並達到預設PFS終點。KN046-301是一項多中心、隨機、雙盲、安慰劑對照的III期臨床試驗,旨在評估KN046聯合含鉑化療治療晚期不可切除或轉移性鱗狀NSCLC患者的療效及安全性。
集團指,由獨立數據監察委員會(iDMC)審查的KN046-301的第一次期中分析結果顯示,該試驗達到基於盲態獨立影像評估委員會(BIRC)評估的PFS共同主要終點。期中分析結果表明,與單純化療相比,KN046聯合含鉑化療在晚期鱗狀NSCLC患者中,獲得了統計學顯著且具有臨床意義的PFS改善,達到預設的優效性標準。
KN046是集團自主研發的全球性首創PD-L1/CTLA-4雙特異性抗體,同時靶向具有明顯結構差異的PD-L1及CTLA-4,可改變腫瘤微環境的定位及減少脫靶毒性。目前,KN046在中國、美利堅合眾國和澳大利亞已開展覆蓋NSCLC、三陰乳腺癌、食管鱗狀細胞癌、肝細胞癌、PDAC、胸腺癌等10餘種腫瘤的近20個不同階段臨床試驗。
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