恆瑞醫藥(600276.SH):向藥監局藥品審評中心遞交上市前的溝通交流申請
格隆匯6月4日丨恆瑞醫藥(600276.SH)公吿,近日,公司研發的馬來酸吡咯替尼片聯合曲妥珠單抗加多西他賽術前治療早期或局部晚期HER2陽性乳腺癌的隨機、雙盲、平行對照、多中心的III期臨牀研究(HR-BLTN-III-NeoBC研究),主要研究終點-總體病理完全緩解(tpCR)達到方案預設的優效標準。研究結果表明,對於早期或局部晚期HER2陽性乳腺癌,在多西他賽和曲妥珠單抗的基礎上聯用吡咯替尼的新輔助治療能夠顯著提高患者的tpCR率。公司將於近期向國家藥品監督管理局藥品審評中心遞交上市前的溝通交流申請。
此項研究(HR-BLTN-III-NeoBC)是一項評價馬來酸吡咯替尼片聯合曲妥珠單抗加多西他賽對比安慰劑聯合曲妥珠單抗加多西他賽術前治療早期或局部晚期HER2陽性乳腺癌的有效性和安全性的隨機、雙盲、平行對照、多中心的III期臨牀研究(NCT03588091),由復旦大學附屬腫瘤醫院吳炅教授擔任主要研究者,全國17家中心共同參與。主要研究終點是獨立評審委員會(IRC)通過病理學評估的總體病理完全緩解(tpCR),次要研究終點包括參研中心病理科醫生評估的tpCR、無事件生存時間(EFS)、無疾病生存時間(DFS)、無遠處轉移生存時間(DDFS)、客觀緩解率(ORR)和安全性。
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