基石藥業-B(02616.HK)向歐洲藥品管理局遞交舒格利單抗治療III期非小細胞肺癌的新適應症申請
格隆匯3月24日丨基石藥業-B(02616.HK)發佈公告，公司已向歐洲藥品管理局(EMA)提交舒格利單抗的新適應症申請，用於治療同步或序貫放化療(CRT)後未出現疾病進展的、不可切除的III期非小細胞肺癌(NSCLC)患者。這是繼2024年該藥物首次獲EMA批準用於轉移性鱗狀和非鱗狀NSCLC一線治療後，基石藥業在歐洲市場推進的第二項適應症。若順利獲批，舒格利單抗將填補III期非小細胞肺癌這一疾病領域的關鍵需求，成爲歐洲第二款治療該適應症的PD-(L)1抗體，同時，舒格利單抗在III期和IV期非小細胞肺癌中的雙重應用，將進一步鞏固其作爲肺癌核心免疫療法的地位。
此次申請是基於一項名爲GEMSTONE-301的多中心、隨機、雙盲的III期臨牀研究，研究旨在評估舒格利單抗作爲鞏固治療用於CRT後不可切除的III期NSCLC患者的有效性和安全性。 GEMSTONE-301研究結果已全文發表於《柳葉刀·腫瘤學》，其結果表明：舒格利單抗可顯着延長患者的無進展生存期(PFS)，降低36%的疾病進展或死亡風險；明顯的總生存期(OS)獲益趨勢，死亡風險降低56%；無論患者是接受同步或是序貫放化療，均觀察到一致的臨牀獲益；安全性良好，未發現新的風險信號。
基石藥業首席執行官、研發總裁及執行董事楊建新博士表示：“繼舒格利單抗在歐洲成功獲批治療IV期NSCLC後，我們與EMA開展了密切協作，積極推進其在肺癌早期階段及其他瘤種的適應症拓展。基於突出的療效與良好的安全性，舒格利單抗有望解決III期NSCLC患者亟待滿足的臨牀需求。此外，我們將繼續深化國際戰略合作，並與監管機構緊密協作，以提高舒格利單抗在全球範圍內的可及性，確保這一創新療法早日惠及全球患者。”
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