中國生物製藥(01177.HK)：貝莫蘇拜單抗聯合安羅替尼一線治療PD-L1陽性非小細胞肺癌III期研究數據在2025年ASCO年會公佈
格隆匯6月3日丨中國生物製藥(01177.HK)發佈公告，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鹽酸安羅替尼膠囊對比帕博利珠單抗注射液一線治療PD-L1陽性晚期非小細胞肺癌(NSCLC)的III期臨牀最新研究成果：達到無進展生存期(PFS)的主要研究終點，其中在TPS≥50%的人羣中，中位PFS較帕博利珠單抗組延長超過6個月，疾病進展╱死亡風險降低40%。
CAMPASS研究是一項隨機、對照III期臨牀研究，共納入531例PD-L1表達陽性（TPS≥1%）的局部晚期（IIIB/C期）或復發╱轉移性NSCLC受試者。受試者以2︰1比例隨機分組，分別接受貝莫蘇拜單抗聯合安羅替尼或帕博利珠單抗聯合安慰劑治療，主要終點爲獨立評審委員會(IRC)根據RECIST 1.1評估的PFS。
本次公佈的結果爲主要終點PFS的最終分析數據，貝莫蘇拜單抗聯合安羅替尼組和帕博利珠單抗組的中位隨訪時間分別爲11.4個月和10.6個月，數據成熟度較高。
在全人羣中，貝莫蘇拜單抗聯合安羅替尼組的中位PFS達到11.0個月，較帕博利珠單抗組（7.1個月）提升3.9個月，疾病進展╱死亡風險降低30%(HR=0.70)。貝莫蘇拜單抗聯合安羅替尼組經確認的腫瘤客觀緩解率(ORR)和疾病控制率(DCR)分別爲57.3%和85.9%，均較帕博利珠單抗組的39.5%和79.1%有顯著提升。
亞組分析顯示，幾乎所有亞組均可從貝莫蘇拜單抗聯合安羅替尼治療方案中獲益。特別值得關注的是，在TPS≥50%的人羣中，貝莫蘇拜單抗聯合安羅替尼組較帕博利珠單抗組，中位PFS延長6.1個月，疾病進展╱死亡風險降低40%(HR=0.60)。目前，臨牀實踐更傾向對TPS≥50%患者採用無化療方案，進一步凸顯了該研究的重大臨牀價值。
在安全性方面，貝莫蘇拜單抗聯合安羅替尼組的常見治療相關不良事件均爲多靶點抗血管生成酪氨酸激酶抑制劑(TKI)或免疫治療的常見不良事件，未觀察到新的安全性信號。值得注意的是，儘管貝莫蘇拜單抗聯合安羅替尼組因療效優勢而顯著延長了中位治療時間，但耐受性並未受到明顯影響，其治療相關不良事件導致任意藥物永久終止治療的發生率(7.1%)和治療相關不良事件導致死亡的發生率(1.4%)均略低於帕博利珠單抗組（分別爲8.0%和2.3%）。
CAMPASS研究是全球首個抗PD-L1單抗聯合多靶點抗血管生成TKI用於PD-L1陽性晚期NSCLC一線治療的III期臨牀研究，該研究達到了PFS主要終點，尤其是對於TPS≥50%人羣，中位PFS提升超過6個月，具有顯著的臨牀價值，有望爲中國PD-L1陽性晚期NSCLC患者提供更優的一線治療選擇。
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