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基石藥業-B(02616.HK):舒格利單抗III期非小細胞肺癌註冊性研究最終無進展生存期分析確認期中分析的顯著療效,獲益進一步增強
格隆匯 05-17 08:08

格隆匯5月17日丨基石藥業-B(02616.HK)發佈公吿,舒格利單抗作為鞏固治療在同步或序貫放化療後未發生疾病進展的、不可切除的III期非小細胞肺癌(“NSCLC”)患者的註冊性臨牀試驗 (GEMSTONE-301研究)無進展生存期(“PFS”)預設最終分析結果。舒格利單抗進一步改善盲態獨立中心審閲(“BICR”)評估的PFS,差異具有統計學顯著性與臨牀意義。亞組分析顯示,無論同步還是序貫放化療後的患者均顯示出臨牀獲益。舒格利單抗的安全性良好,未發現新的安全性信號。詳細研究數據將於近期召開的國際學術會議中公佈。

GEMSTONE-301研究主要研究者、廣東省人民醫院終身主任吳一龍教授表示:“相比去年PFS 期中分析的優異數據,在本次PFS最終分析中,舒格利單抗作為鞏固治療,在既往接受了同步或序貫放化療的III期NSCLC患者中均顯示了更持久的PFS和總生存期,舒格利單抗作為放化療後III期NSCLC患者的鞏固治療已被納入《2022版CSCO非小細胞肺癌診療指南》,此次數據的更新為舒格利單抗成為該人羣的標準治療選擇提供了進一步的數據支援。

基石藥業首席醫學官楊建新博士表示:“很高興看到GEMSTONE-301研究在PFS最終分析中再次顯示出了顯著的延長,且無論同步還是序貫放化療後的患者均有臨牀獲益。基於此前優異的期中分析結果,舒格利單抗治療III期NSCLC的新藥上市申請正在審評中,有望成為全球首個獲批用於治療同步或序貫放化療III期NSCLC患者的PD-(L)1抗體。同時我們也欣喜地觀察到持續的總生存期獲益趨勢,我們期待舒格利單抗在全球範圍內獲批,以優異的療效和安全性數據造福廣大的肺癌患者。

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