基石藥業-B(02616.HK)：GEMSTONE-302最終分析結果證實期中分析舒格利單抗聯合化療對轉移性NSCLC的顯著療效和良好安全性，生存獲益進一步增強
格隆匯7月12日丨基石藥業-B(02616.HK)發佈公吿，基石藥業宣佈舒格利單抗用於一線治療IV期非小細胞肺癌(“NSCLC”)的註冊性臨牀研究(GEMSTONE-302)無進展生存期(“PFS”)最終分析結果。更新的數據顯示：繼去年在PFS期中分析時達到了主要療效終點後,在近期的PFS最終分析中，舒格利單抗聯合化療進一步延長了患者的PFS。同時，這一延長隨訪時間的數據進一步證實了舒格利單抗聯合化療可為患者帶來持久的生存獲益。憑藉獨特的作用機理和在多個腫瘤中取得的積極臨牀數據，舒格利單抗顯示出了成為同類最佳的巨大潛力。繼舒格利單抗在肺癌III和IV期臨牀研究、普吉華?(普拉替尼膠囊)一線治療NSCLC研究取得成功，以及攜手輝瑞共同開發ROS1抑制劑勞拉替尼後，基石藥業在肺癌精準治療與免疫治療領域佔據絕對優勢。
GEMSTONE-302研究主要研究者、上海市肺科醫院腫瘤科主任周彩存教授表示：“在全球範圍內，肺癌的死亡率位居所有惡性腫瘤之首。肺癌治療的最終目標是延長患者的總生存期。相比去年期中分析的優秀數據，在本次PFS最終分析中，舒格利單抗聯合化療顯示出更長的PFS和持久的生存獲益。同時進一步證實了，舒格利單抗聯合化療一線治療轉移性NSCLC的安全性和有效性，再次突出了舒格利單抗對改善患者長期治療結局的臨牀優勢。”
基石藥業首席醫學官楊建新博士表示：“GEMSTONE-302研究採用了創新性設計，同時涵蓋鱗狀和非鱗狀NSCLC兩種亞型，優異的期中分析結果使其有望成為全球首個聯合化療同時獲批鱗狀和非鱗狀NSCLC一線治療的抗PD-L1單抗。本次最終分析結果更加令人驚喜，不僅PFS延續了期中分析的獲益優勢，我們還激動的看到關鍵次要研究終點總生存期(“OS”)的獲益也進一步增強，這一系列令人振奮的結果證明了舒格利單抗作為同類最優藥物的巨大治療價值。同時我們也在全力推進舒格利單抗在血液腫瘤、晚期胃癌和食管癌患者中的註冊性臨牀試驗。”
2020年11月，中國NMPA已受理舒格利單抗的NDA，用於聯合化療一線治療轉移性鱗狀和非鱗狀NSCLC患者，這是基石藥業在全球範圍內遞交的舒格利單抗的首個NDA。此次PFS最終分析詳細研究數據將於近期召開的國際學術會議中公佈。
在中國大陸，基石藥業正與合作伙伴輝瑞緊密合作，儘快推進舒格利單抗的商業化進程。在大中華地區之外，基石藥業將和EQRx公司緊密合作，與多個國家和地區的藥品監督管理部門就舒格利單抗各適應證展開溝通。
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