科倫藥業(002422.SZ):將快速推動A166開展治療HER2陽性乳腺癌關鍵II期臨牀試驗
格隆匯6月20日丨科倫藥業(002422.SZ)公佈,公司董事會宣布,公司控股子公司四川科倫博泰生物醫藥股份有限公司開發的創新藥物A166(一種抗HER2抗體-藥物偶聯物)治療HER2陽性乳腺癌以單臂試驗支持附條件批准上市的關鍵II期試驗已與國家藥品監督管理局藥品審評中心(“CDE”)進行溝通交流,並將快速推動A166關鍵II期試驗。
2021年2月,公司控股子公司四川科倫博泰生物醫藥股份有限公司向CDE提交A166針對HER2陽性乳腺癌末線患者以單臂試驗支持上市進入關鍵試驗前的溝通交流申請。
乳腺癌是嚴重威脅全世界女性健康的第一大惡性腫瘤,其中HER2陽性患者的比例達到20%-25%。目前晚期HER2陽性乳腺癌患者一線治療主要以曲妥珠單抗為基礎,二線以小分子激酶抑制劑為基礎,三線及以後患者尚無獲批的標準治療藥物,具有較大的未滿足臨牀需求。
A166是第三代靶向HER2的抗體偶聯藥物(ADC),通過蛋白酶可裂解linker將新型毒素分子(Duo-5,微管蛋白抑制劑)定點偶聯至HER2抗體(曲妥珠單抗)。臨牀I期劑量遞增和劑量擴增研究結果顯示,A166抗體與毒素分子在血液中結合穩定,整體耐受性、安全性良好,並在經過多線抗HER2治療後的HER2陽性乳腺癌患者中顯示出具有臨牀意義且較優的抗腫瘤活性。
經溝通交流,公司已與CDE針對關鍵II期試驗相關研究設計達成一致意見,並將按照CDE回覆意見,快速組織實施A166關鍵II期臨牀試驗。
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