基石藥業-B(02616.HK)：舒格利單抗可為晚期非小細胞肺癌患者提供新的治療選擇
格隆匯 11 月 23日丨基石藥業-B(02616.HK)發佈公告，2020年歐洲腫瘤內科學會亞洲年會線上年會上以口頭報告形式首次公佈了GEMSTONE-302研究詳細結果。結果顯示舒格利單抗聯合化療較安慰劑聯合化療，作為晚期非小細胞肺癌(“NSCLC”)一線治療，顯著延長了研究者評估的無進展生存期(“PFS”)。結果達到統計學顯著性，且有臨牀意義。舒格利單抗聯合化療的安全性良好，未發現新的安全性信號。
GEMSTONE-302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。該研究主要終點為研究者評估的PFS；次要終點包括總生存期，盲態獨立中心審閲委員會(“BICR”)評估的PFS和安全性等。
截至2020年6月8日，研究共入組479例患者，期中分析資料顯示，舒格利單抗聯合化療對比安慰劑聯合化療，顯著延長患者的PFS，達到了研究的主要終點。
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：“GEMSTONE-302研究創新性的在一個臨牀研究中同時納入肺鱗癌患者和肺腺癌患者，採用免疫聯合化療對比安慰劑聯合化療的研究設計，在一個臨牀研究中同時評估兩種腫瘤組織亞型患者的療效，並最終達到了研究的主要終點，且在肺鱗癌患者和肺腺癌患者中均觀察到了臨牀獲益。肺癌的發病率和致死率在全球均居於首位，相信憑藉本研究的優異資料，舒格利單抗可以為晚期NSCLC患者提供新的治療選擇，並以其低安全風險，高反應率，持久的療效惠及更多的患者。”
基石藥業首席醫學官楊建新博士表示：“GEMSTONE-302研究結果令人鼓舞，舒格利單抗聯合化療降低疾病進展或死亡風險50%，客觀緩解率高達61.4%，且安全耐受。這些優異的結果提示舒格利單抗相比已報過結果的PD-1/PD-L1單抗，具有同類最佳的潛力。目前中國國家藥品監督管理局已正式受理舒格利單抗新藥上市申請。我們期待舒格利單抗能夠早日獲批，惠及更多患者。”
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