基石藥業-B(02616.HK):Nature子刊發表舒格利單抗一線治療IV期非小細胞肺癌總生存期研究成果
格隆匯6月16日丨基石藥業-B(02616.HK)發佈公吿,國際知名期刊Nature子刊Nature Cancer線上發表了舒格利單抗一線治療IV期非小細胞肺癌(NSCLC)的註冊性臨牀研究GEMSTONE-302的總生存期(OS)期中分析結果。這是繼在美國臨牀腫瘤學會(ASCO)年會、世界肺癌大會(WCLC)以及《柳葉刀·腫瘤學》(The Lancet Oncology)公佈數據之後,GEMSTONE-302 再次榮登國際頂尖學術舞台,這也充分顯示了舒格利單抗巨大的學術價值和臨牀意義。
基石藥業首席執行官兼執行董事楊建新博士表示:“我們非常高興能看到GEMSTONE-302的研究成果再次發表於國際知名期刊。該研究兩次預設期中分析結果之所以被The Lancet Oncology和Nature Cancer先後選中,創新的研究設計以及舒格利單抗的優異臨牀表現無疑是兩大重要因素。目前,舒格利單抗一線治療IV期NSCLC的適應症已在國內獲批上市,該適應症在英國和歐盟的上市許可申請也已獲受理並正在審評中。此外,舒格利單抗治療淋巴瘤、胃癌以及食管癌的適應症上市申請正在中國國家藥品監督管理局(NMPA)審評中。我們將與監管機構密切協作,包括美國食品藥品監督管理局(FDA),期待舒格利單抗能夠造福全球患者。”
GEMSTONE-302研究的主要研究者、文章通訊作者、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:“延長OS是腫瘤治療的最終目標和療效評估的金標準。此次發表在Nature Cancer上的研究結果顯示,舒格利單抗聯合化療無論在鱗癌或非鱗癌亞型的晚期肺癌患者中均展示出了持久的臨牀獲益,顯著改善了患者的OS,並具有良好的安全性。基於GEMSTONE302的數據,我們有理由相信舒格利單抗能夠助力更多肺癌患者實現長期生存。”
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