中國生物製藥(01177.HK)：貝莫蘇拜單抗聯合或不聯合安羅替尼鞏固治療放化療後未進展的非小細胞肺癌III期研究數據在2025年ASCO年會公佈
格隆匯6月5日丨中國生物製藥(01177.HK)宣佈，集團已在2025年美國臨牀腫瘤學會(ASCO)年會公佈了貝莫蘇拜單抗注射液聯合或不聯合鹽酸安羅替尼膠囊鞏固治療放化療後未進展的III期非小細胞肺癌(NSCLC)的III期臨牀最新研究成果：貝莫蘇拜單抗聯合安羅替尼組較安慰劑組顯著延長中位無進展生存期(PFS)(15.1個月vs. 4.2個月)，疾病進展或死亡風險降低51%。
該研究(R-ALPS)納入經病理確診、同步╱序貫放化療後未進展的、局部晚期╱不可切除的III期NSCLC患者。截至2023年5月12日，共完成553例患者隨機入組，試驗組1 (209例)為貝莫蘇拜單抗聯合安羅替尼治療、試驗組2 (212例)為貝莫蘇拜單抗聯合安慰劑治療、對照組(132例)為安慰劑治療，中位隨訪時間為19.4個月。
初步結果顯示，試驗組1較對照組顯着延長中位PFS 10.9個月(15.1個月vs. 4.2個月；HR=0.49, 95%CI0.36-0.66，P<0.001)，疾病進展或死亡風險降低51%。試驗組2較對照組顯着延長中位PFS 5.5個月(9.7個月vs. 4.2個月；HR=0.53，95% CI 0.39-0.72，P<0.0001)，疾病進展或死亡風險降低47%。安全性特徵與藥物已知風險譜相符，未出現新的安全性信號，≥3級治療相關不良事件發生率分別為48.8%、29.4%、19.7%。
全球癌症數據統計顯示，肺癌在全球和中國的發病率及死亡率居所有惡性腫瘤的第一位，2022年全球肺癌發病人數高達248萬，其中，中國發病人數達106.1萬。NSCLC約佔所有肺癌的80%-85%。目前，局部晚期╱不可切除的III期NSCLC治療手段有限，主要為同步╱序貫放化療後繼續使用免疫單藥進行鞏固治療。
作為全球首個在同步╱序貫放化療後未進展III期NSCLC領域的聯合用藥研究，R-ALPS研究驗證了靶向免疫聯合鞏固治療的有效性和安全性，刷新了該領域的PFS獲益紀錄。基於該研究結果，貝莫蘇拜單抗聯合或不聯合安羅替尼的新適應症上市申請已於2025年4月由中國國家藥品監督管理局藥品審評中心(CDE)受理。該研究的突破性成果，或將重塑臨牀實踐指南，造福更多NSCLC患者。
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