基石藥業-B(02616.HK)：擇捷美®治療復發難治淋巴瘤註冊性臨牀研究達到主要終點，擬遞交新適應症上市申請
格隆匯1月13日丨基石藥業-B(02616.HK)發佈公吿，擇捷美®治療復發或難治性結外自然殺傷細胞/T細胞淋巴瘤(“R/R ENKTL”)的註冊性臨牀研究(GEMSTONE-201)達到主要研究終點。經獨立影像評估委員會(“IRRC”)評估，相較於歷史對照，擇捷美®顯著提高了客觀緩解率(“ORR”)；研究者評估的ORR與IRRC評估結果一致；並且擇捷美®在R/R ENKTL患者中安全性良好，未發現新的安全性信號。基石藥業計劃近期向中國國家藥品監督管理局(“NMPA”)遞交擇捷美®針對R/R ENKTL適應症的新藥上市申請，具體研究數據將於近期召開的國際學術會議中公佈。
GEMSTONE-201主要研究者、中山大學附屬腫瘤醫院黃慧強教授表示：“R/R ENKTL惡性程度高、侵襲性強。臨牀上一直缺乏有效治療藥物，導致該疾病治癒率低、預後差。此次GEMSTONE-201研究取得成功，表明擇捷美®能夠成為R/R ENKTL患者新的治療選擇，滿足該羣體非常迫切的治療需求。”
基石藥業首席醫學官楊建新博士表示：“我們高興的看到擇捷美®治療R/R ENKTL的註冊研究達到主要研究終點，這是繼III期和Ⅳ期非小細胞肺癌(“NSCLC”)註冊研究之後，擇捷美®取得成功的第三項關鍵臨牀研究。目前尚無PD-1或PD-L1抗體被批准用於治療R/R ENKTL，因此我們非常期待擇捷美®造福更多患者。”
近日，NMPA已批准潛在同類最優藥物擇捷美®的新藥上市申請，用於聯合化療一線治療鱗狀或非鱗狀IV期NSCLC患者。此外，針對III期NSCLC的新藥上市申請也正在審評中。擇捷美®將有望為III期和IV期NSCLC全人羣患者提供新的治療選擇。擇捷美®獨特的作用機理和在肺癌、淋巴瘤等腫瘤中取得的優異的臨牀數據顯示出擇捷美®的巨大潛力。
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