基石藥業-B(02616.HK)：舒格利單抗一線治療轉移性NSCLC的GEMSTONE-302研究達到總生存期研究終點
格隆匯1月19日丨基石藥業-B(02616.HK)發佈公吿，舒格利單抗一線治療轉移性(IV期)非小細胞肺癌(“NSCLC”)的註冊性臨牀研究GEMSTONE-302達到總生存期(“OS”)的研究終點。研究顯示：舒格利單抗聯合化療可顯著延長患者的OS並具有臨牀意義。基於此前GEMSTONE-302研究報道的優異的無進展生存期(“PFS”)數據，中國國家藥品監督管理局(“NMPA”)已於2021年12月批准舒格利單抗的新藥上市申請，用於聯合化療一線治療轉移性鱗狀和非鱗狀NSCLC患者。OS等詳細的研究數據將在近期召開的國際學術會議中公佈。
舒格利單抗註冊性臨牀研究GEMSTONE-302研究的主要研究者、同濟大學附屬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。晚期肺癌一線治療的目標是最大限度地提高患者的長期生存獲益，延緩疾病進展。研究預設的OS分析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。舒格利單抗有望改變晚期NSCLC一線治療格局，成為晚期NSCLC的首選腫瘤免疫治療藥物。”
基石藥業首席醫學官楊建新博士表示：“舒格利單抗喜訊連連，繼上個月在國內獲批上市，近日開出首批處方後，GEMSTONE-302在此次的OS分析中證明，舒格利單抗聯合化療顯著改善患者的OS，即使化療對照組中較高比例的患者在疾病進展後接受了後續的PD-1/PD-L1抑制劑治療，包括基於方案設計的交叉治療。在腫瘤治療中，OS是評價療效的金標準。此次OS研究終點的達成，進一步證明了舒格利單抗在一線NSCLC治療中的重要價值。作為一款可以使III期和IV期NSCLC患者均獲益的PD-(L)1抗體，舒格利單抗治療III期NSCLC的新藥上市申請目前在審評中，針對治療復發或難治性結外自然殺傷細胞/T細胞淋巴瘤的關鍵性II期研究也在近日達到了主要終點。另外，我們在全力推進舒格利單抗在胃癌、食管鱗癌以及淋巴瘤的註冊研究，希望舒格利單抗可以造福更多腫瘤患者。”
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