基石藥業-B(02616.HK)宣佈有關CS1003-305研究最新進展
格隆匯7月4日丨基石藥業-B(02616.HK)公告,基石藥業今日宣佈有關CS1003-305研究的最新進展。
CS1003-305研究是一項國際多中心、雙盲、隨機對照的III期註冊研究,在全球範圍內設有74家研究中心,旨在評估PD-1單抗nofazinlimab(CS1003)聯合侖伐替尼對比安慰劑聯合侖伐替尼一綫治療不可切除或轉移性肝細胞癌(HCC)患者的有效性和安全性。該研究的主要終點爲總生存期(OS)。關鍵次要終點包括盲態獨立中心審閲(BICR)評估的無進展生存期(PFS)和客觀緩解率(ORR)。
最終分析結果顯示nofazinlimab聯合侖伐替尼對比安慰劑聯合侖伐替尼,OS呈現出明顯的臨牀獲益趨勢,儘管未達到統計學顯著性,但仍顯示出切實的患者獲益。此外,該聯合療法在PFS和ORR方面也取得有臨牀意義的改善,其數據與目前標準療法治療數據可比。並且,nofazinlimab安全性良好,與既往研究結果以及已上市的抗PD-(L)1抗體安全性特徵一致,未觀察到新的安全性信號。公司將與監管機構溝通,尋求該聯合療法的註冊路徑。
Nofazinlimab是一種靶向人程序性細胞死亡蛋白1(PD-1)的人源化重組IgG4單克隆抗體,正在開發用於腫瘤的免疫治療。Nofazinlimab與人類、食蟹猴和小鼠PD-1均具有高親和力,可阻斷PD-1與PD-L1和PD-L2配體的相互作用。
Nofazinlimab已於2020年7月獲美國食品藥品監督管理局(FDA)授予孤兒藥資格(Orphan Drug Designation,ODD),用於治療肝細胞癌。
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