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基石藥業(02616.HK)舒格利單抗治療III期非小細胞肺癌臨床試驗達到主要終點 將遞新藥上市申請
阿思達克 05-28 08:34
基石藥業-B(02616.HK)公布,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、局部晚期/不可切除(III期)的非小細胞肺癌(「NSCLC」)患者的註冊性臨床試驗(GEMSTONE-301研究)在計劃的期中分析中,經獨立資料監查委員會(「iDMC」)評估達到了預設的主要研究終點。

試驗結果顯示,舒格利單抗顯著改善盲態獨立中心審閱(「BICR」)評估的無進展生存期(「PFS」),差異具有統計學顯著性與臨床意義。研究者評估的PFS結果與主要研究終點一致。舒格利單抗的安全性良好,未發現新的安全性信號。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。

集團計劃近期將向中國國家藥品監督管理局遞交III期NSCLC的新藥上市申請(「NDA」),並將和EQRx公司緊密合作,與包括美國食品藥品監督管理局(「FDA」)在內的多個國家和地區的藥品監督管理部門就III期和IV期NSCLC兩個適應症的新藥上市申請展開溝通。

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