基石藥業-B(02616.HK)在IASLC 2021 WCLC以口頭報吿形式公佈舒格利單抗治療IV期非小細胞肺癌註冊性臨牀研究更新數據
格隆匯9月14日丨基石藥業-B(02616.HK)發佈公吿，基石藥業在由國際肺癌研究協會舉辦的2021年世界肺癌大會(“IASLC 2021 WCLC”)上，以口頭報吿形式(Late-breaking abstract, LBA)公佈了舒格利單抗用於一線治療IV期非小細胞肺癌(“NSCLC”)的註冊性臨牀研究(GEMSTONE-302研究)的PFS最終分析結果。
GEMSTONE-302研究是全球首個抗PD-L1單抗聯合化療作為一線治療在IV期鱗狀和非鱗狀NSCLC患者中的隨機雙盲III期臨牀試驗。該研究旨在評估舒格利單抗聯合化療對比安慰劑聯合化療，在未經一線治療的、IV期NSCLC患者中的有效性和安全性。
GEMSTONE-302研究主要研究者、上海市肺科醫院腫瘤科主任周彩存教授表示：“全球範圍內，肺癌的死亡率位居所有惡性腫瘤之首。本次GEMSTONE-302研究的PFS最終分析結果顯示，在包含鱗狀和非鱗狀NSCLC的所有患者中，相比安慰劑聯合化療，舒格利單抗聯合化療進一步顯著延長了IV期NSCLC患者的PFS，OS數據已顯示出獲益趨勢，2年的總生存率接近50%，我們期待舒格利單抗聯合化療為患者帶來更長的生存獲益。”
基石藥業首席醫學官楊建新博士表示：“隨着隨訪時間的延長，我們高興地看到舒格利單抗聯合化療進一步增加了PFS獲益，並且在不同細胞組織亞型(鱗狀和非鱗狀)和不同PD-L1表達亞組中PFS均有獲益，同時總生存期顯示出了明顯獲益趨勢。舒格利單抗聯合化療的安全性良好，相比化療沒有明顯增加3級及以上的TEAE和irAE。舒格利單抗在局部晚期(III期)和轉移性(IV期)NSCLC的優異數據讓我們堅信舒格利單抗在所有PD-1和PD-L1單抗中具備成為同類最優的潛質。同時我們將繼續推進舒格利單抗在食管鱗癌、胃癌、復發/難治性自然殺傷T細胞淋巴瘤的註冊性臨牀研究，惠及更多腫瘤患者。”
2020年11月，中國國家藥品監督管理局(“NMPA”)已受理舒格利單抗的新藥上市申請，用於聯合化療一線治療晚期鱗狀和非鱗狀NSCLC患者。此外，2021年9月，中國NMPA受理了舒格利單抗的新藥上市申請，用於治療同步或序貫放化療後未發生疾病進展的不可切除的III期非小細胞肺癌患者。
在中國大陸，基石藥業正與獲得該藥物商業授權的合作伙伴輝瑞緊密合作，加速推進舒格利單抗的商業化進程。在大中華地區以外，基石藥業將和EQRx公司緊密合作，與多個國家和地區的藥品監督管理部門就舒格利單抗的各適應症展開溝通。
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