基石藥業-B(02616.HK)：舒格利單抗兩項重磅三期註冊性臨牀試驗完成受試者入組
格隆匯1月18日丨基石藥業-B(02616.HK)發佈公吿，其自主研發的全人源及全長抗PD-L1單抗舒格利單抗兩項重磅三期註冊性臨牀試驗完成全部受試者入組，分別是舒格利單抗聯合化療一線治療無法手術切除的局部晚期或轉移性胃腺癌/胃食管結合部腺癌(GEJ)的GEMSTONE-303研究以及舒格利單抗聯合化療一線治療無法手術切除的局部晚期，復發或轉移性食管鱗癌(“食管鱗癌”)的 GEMSTONE-304研究。
基石藥業首席醫學官楊建新博士表示：“我們很高興看到舒格利單抗在消化道腫瘤領域的兩項重磅研究，一線聯合化療治療胃癌和食管癌的III期註冊研究順利完成全部受試者入組。這是舒格利單抗繼2021年12月於中國大陸獲批上市、用於一線治療Ⅳ期NSCLC，2021年9月成功向NMPA遞交III期NSCLC的新藥上市申請以及2022年1月用於治療R/RENKTL註冊性臨牀研究達到主要終點後，基石藥業產品研發管線的又一重要進展。我們要感謝所有參與到研究中的研究者，受試者及其家屬。同肺癌一樣，胃癌和食管癌的發病率和死亡率在全球尤其是中國位居前列，廣大患者仍面臨着巨大未被滿足的治療需求。我們期待這兩項研究結果可以早日為患者帶來更好的治療選擇。”
胃癌和食管癌是全球常見的癌症之一，據GLOBOCAN 2020數據，2020年全球新發胃癌病例超過100萬例，死亡病例達76.9萬例，是全球第5位的常見癌症和第4位的癌症死亡原因；新發食管癌的病例超過60萬例，死亡病例達54.4萬例，是全球第8位常見癌症和第6位癌症死亡原因。胃腺癌的發生率佔胃惡性腫瘤的90%以上，胃食管結合部腺癌的發病率近年來也呈上升趨勢。另據統計，中國食管癌患者中約90%為食管鱗癌，且多數食管鱗癌患者在確診時已為局部晚期或轉移性，失去根治性治療的機會。
GEMSTONE-303研究為一項多中心、安慰劑對照的三期註冊性臨牀試驗，旨在評估舒格利單抗聯合CAPOX化療方案(奧沙利鉑+卡培他濱)作為一線治療無法手術的局部晚期或轉移性胃腺癌或胃食管結合部腺癌的療效和安全性。Ib期研究顯示，舒格利單抗聯合CAPOX化療方案做為一線治療胃癌或胃食管交界處癌的客觀緩解率達到62.1%(18/29)，疾病控制率(“DCR”)達到82.8%，且緩解可持續。
GEMSTONE-304研究為一項多中心、安慰劑對照的三期註冊性臨牀試驗，旨在評估舒格利單抗聯合FP化療方案(氟尿嘧啶+順鉑)作為一線治療無法手術切除的局部晚期、復發或轉移性食管鱗癌的療效和安全性。Ib期研究顯示，舒格利單抗聯合FP化療方案作為一線治療晚期食管鱗癌的ORR達到67.6%(25/37)，DCR達到89.2%，且緩解可持續。
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