基石藥業-B(02616.HK):洛拉替尼治療ROS1陽性晚期非小細胞肺癌關鍵性臨牀試驗申請在中國獲批
格隆匯1月4日丨基石藥業-B(02616.HK)發佈公吿,洛拉替尼(lorlatinib,曾用名:勞拉替尼)針對c-ros oncogene1(“ROS1”)陽性晚期非小細胞肺癌(“NSCLC”)的臨牀試驗申請(“IND”)已獲中國國家藥品監督管理局(“NMPA”)批准。這是全球首個洛拉替尼用於治療ROS1陽性NSCLC的關鍵性研究。
洛拉替尼是一種具中樞神經系統穿透力的第三代ALK/ROS1酪氨酸激酶抑制劑(“TKI”)。憑藉其在CROWN研究中的數據,洛拉替尼已獲美國食品藥品監督管理局(“FDA”)批准,其適應症範圍擴展至用於一線治療經FDA批准的檢測方法確診的ALK陽性轉移性NSCLC成人患者。
本項關鍵性研究旨在評估洛拉替尼在ROS1陽性晚期NSCLC患者中的抗腫瘤活性和安全性。在先前一項I/II期研究中,洛拉替尼在未經TKI治療或TKI治療失敗的ROS1陽性晚期NSCLC患者中顯現了深入且持久的客觀緩解。
基石藥業首席醫學官楊建新博士表示:“目前ROS1陽性NSCLC患者出現初治耐藥後,缺乏有效的護理標準。我們很高興洛拉替尼獲批在中國開展治療ROS1陽性NSCLC患者的關鍵性研究。該研究將入組經化療和精準治療失敗的ROS1陽性晚期NSCLC患者,研究的首要終點為獨立評審委員會評估的客觀緩解率(“ORR”)。我們將加速推進洛拉替尼的臨牀研究,早日為患者帶來更多治療選擇。”
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