基石藥業-B(02616.HK)在ESMO年會將以口頭報吿形式公佈NSCLC註冊性臨牀研究數據
格隆匯9月17日丨基石藥業-B(02616.HK)發佈公吿，在2021年歐洲腫瘤內科學會(“ESMO”)年會上，舒格利單抗治療III期非小細胞肺癌(“NSCLC”)的註冊性臨牀研究GEMSTONE-301入選ESMO年會重磅摘要(“LBA”)並將以口頭報吿公佈其詳細數據。
GEMSTONE-301研究主要研究者、廣東省人民醫院吳一龍教授表示：“目前，臨牀上針對經過序貫放化療後未發生疾病進展的III期NSCLC患者缺乏有效治療手段。GEMSTONE-301研究的數據表明舒格利單抗作為鞏固治療，可以顯著延長患者PFS，無論是同步還是序貫放化療後的患者均顯示出臨牀獲益，且安全性良好。GEMSTONE-301研究取得的成功結果表明舒格利單抗必將滿足這部分患者迫切的治療需求。”
基石藥業首席醫學官楊建新博士表示：“我們高興地看到GEMSTONE-301研究入選ESMO的LBA並將進行口頭彙報。優異的數據在國際肺癌學術界引起了廣泛關注和熱烈討論，讓我們感到非常驕傲和自豪。基石藥業一直致力於解決未被滿足的臨牀需求，通過GEMSTONE-301研究，促進了中國III期肺癌的多學科診療(“MDT”)合作，提高了III期肺癌的診療品質。舒格利單抗在局部晚期(III期)和轉移性(IV期)NSCLC的優異數據使其有望成為全球首個同時覆蓋III期和IV期 NSCLC全人羣的PD-(L)1單抗，進一步夯實其同類最優的品質。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。”
目前，中國NMPA已受理舒格利單抗治療不可切除的III期NSCLC的NDA。此外，舒格利單抗治療轉移性(IV期)NSCLC的NDA已於去年獲中國NMPA受理，目前正在審評中。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，基石藥業將繼續和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該III期和IV期NSCLC的兩個適應症展開溝通。
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