基石藥業(02616.HK)洛拉替尼治療ROS1陽性晚期非小細胞肺癌的關鍵性臨牀試驗申請在中國獲批
1月4日，港股創新藥企基石藥業(02616.HK)宣佈，洛拉替尼(lorlatinib，曾用名：勞拉替尼)針對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治療ROS1陽性NSCLC的關鍵性研究。
據瞭解，該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，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)。
統計數據顯示，中國每年確診NSCLC病例超過67萬，其中大約2%-3%患者是由ROS1基因重排致病，規模在2萬人左右，多見於年輕、不吸煙或輕度吸煙肺腺癌患者中。作為第三代ALK/ROS1酪氨酸激酶抑制劑，洛拉替尼可以為ROS1陽性晚期非小細胞肺癌患者提供新的治療選擇。
洛拉替尼是一種具有強效和選擇性抑制活性的第三代ALK/ROS1酪氨酸激酶抑制劑(TKI)，並能夠穿透血腦屏障。憑藉其優異的臨牀數據，洛拉替尼已在全球50多個國家獲批用於治療成人ALK陽性轉移性NSCLC患者。而在之前一項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，其ORR與顱內ORR均有改善。針對腦轉移陽性的患者，洛拉替尼獲得了較高的緩解率以及持久的緩解時間。
對此，基石藥業首席醫學官楊建新博士表示，目前ROS1陽性NSCLC患者出現耐藥後，缺乏有效治療手段。“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。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。”
值得注意的是，該研究是基石藥業與輝瑞戰略合作的進一步深化。2020年9月，基石藥業與輝瑞達成戰略合作，其中包括雙方將更多腫瘤產品引入大中華地區的合作框架。2021年6月，基石藥業與輝瑞共同宣佈，雙方將在大中華地區共同開發洛拉替尼，開展針對ROS1陽性NSCLC的研究，在癌症領域為廣大患者帶來更多的治療選擇。
此次洛拉替尼獲批進行關鍵性臨牀研究，也是基石藥業近期獲得的又一個好消息。就在上月末，潛在同類最佳藥物PD-L1抗體藥物擇捷美®(舒格利單抗注射液)獲得NMPA批准上市，潛在全球同類最佳藥物CS5001(ROR1 ADC)臨牀試驗申請獲FDA批准開展臨牀研究。基石藥業在精準治療與免疫治療領域的優勢進一步凸顯。
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