基石藥業(02616.HK)發布舒格利單抗治療III期非小細胞肺癌註冊性臨床研究數據
基石藥業-B(02616.HK)公布,在2021年歐洲腫瘤內科學會年會上,舒格利單抗治療III期非小細胞肺癌(NSCLC)的註冊性臨床研究GEMSTONE-301入選ESMO年會重磅摘要並將以口頭報告公布其詳細數據。
試驗結果顯示,舒格利單抗顯著改善盲態獨立中心審閱(「BICR」)評估的PFS,患者疾病進展或死亡風險降低36%,並顯示出總生存期(「OS」)明顯的獲益趨勢,死亡風險降低56%。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床獲益。
國家藥品監督管理局已受理舒格利單抗治療不可切除的III期NSCLC的新藥上市申請。
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