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東曜藥業(01875.HK)在ESMO ASIA首次公佈TAB008(貝伐珠單抗注射液)III期研究結果
格隆匯 11-23 14:27

2020年11月22日,東曜藥業(香港聯交所股票代碼:1875)宣佈,其自主研製的貝伐珠單抗生物類似藥TAB008(擬用商品名:樸欣汀®、Pusintin®)的III期臨牀研究結果在2020年歐洲腫瘤內科學會亞洲年會(ESMO ASIA)發表,並以電子壁報(E-Poster)的形式展示。

本研究是一項隨機、雙盲、陽性藥平行對照、多中心的III期臨牀研究,旨在評估相比原研貝伐珠單抗,TAB008聯合紫杉醇和卡鉑一線治療晚期或局部治療後復發的非鱗狀非小細胞肺癌患者的有效性、安全性和免疫原性,主要終點指標為治療6個週期內的最佳客觀緩解率(ORR)。

該研究由上海交通大學附屬胸科醫院腫瘤科陸舜教授和南京金陵醫院腫瘤中心秦叔逵教授團隊牽頭完成。

研究共入組549例患者,TAB008組277例,原研組272例(有1例患者隨機後,未用藥,未納入全分析集),兩組受試者基線特徵無顯著差異。

試驗顯示:

● TAB008組和原研組的ORR分別為55.957%和55.720%,表明兩組主要療效指標具有相似性;● 6週期內的疾病控制率、緩解持續時間、無進展生存期、1年生存率、總生存期等次要有效性終點具有相似性;● TAB008組和原研組治療中出現的不良事件和嚴重不良事件發生率基本類似,組間差異無統計學意義,大部分不良事件臨牀容易控制;TAB008組和原研組中分別有3例(1.08%)受試者和5例(1.85%)受試者出現抗藥抗體陽性;● TAB008和原研藥給藥後的穩態谷濃度具有生物等效性

試驗結論:

本臨牀試驗研究結果表明TAB008與原研貝伐珠單抗在一線治療晚期或局部治療後復發的非鱗狀非小細胞肺癌患者時,有效性、安全性、免疫原性和藥代動力學特徵相似。

東曜藥業首席執行官、首席科學官兼執行董事劉軍博士表示:“TAB008是東曜藥業第一個獲上市申請受理的重量級生物藥,很高興看到III期研究中表現出的可喜結果。在推進研發的同時,東曜藥業已經搭建起了16000L大規模單抗生產能力,讓我們對TAB008未來進入商業化階段充滿信心。除了單抗藥物,公司還佈局了ADC等領域,研究開發了多個系列、多個品種的抗腫瘤藥物,力求以創新科技提升全球癌症患者生命質量。”

來源:東曜藥業

原標題:東曜藥業在ESMO ASIA首次公佈TAB008(貝伐珠單抗注射液)III期研究結果

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