中國生物製藥(01177.HK)：貝莫蘇拜單抗聯合安羅替尼一線治療鱗狀非小細胞肺癌III期研究數據在2025年ASCO年會公佈
格隆匯5月23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化療後序貫聯合鹽酸安羅替尼膠囊對比替雷利珠單抗注射液聯合化療用於晚期鱗狀非小細胞肺癌(sq-NSCLC)一線治療的III期臨牀最新研究成果：試驗組中位無進展生存期(mPFS)爲10.12個月，與對照組相比疾病進展風險降低36%。
全球首個對比免疫檢查點抑制劑聯合化療一線治療sq-NSCLC取得陽性結果的Ⅲ期臨牀研究
「貝莫蘇拜單抗聯合化療後序貫聯合安羅替尼」方案爲全球首個頭對頭PD-1單抗聯合化療一線治療sqNSCLC獲得顯著陽性結果的Ⅲ期臨牀研究。該方案的上市申請已於今年4月獲得中國國家藥品監督管理局藥品審評中心(CDE)受理。
截至2024年3月1日，565名患者按1:1隨機分配至試驗組和對照組，兩組受試者基線特徵基本均衡。研究數據表明，「貝莫蘇拜單抗聯合化療後序貫聯合安羅替尼」方案與「替雷利珠單抗聯合化療」方案相比，顯著延長mPFS (10.12個月vs. 7.79個月，HR=0.64，P=0.0038)，試驗組疾病進展╱死亡風險降低36%。試驗組和對照組客觀緩解率(ORR)分別爲71.9%和65.1%。試驗組的中位緩解持續時間(DoR)顯著長於對照組(9.69個月vs. 8.34個月，HR=0.58，P=0.0091)。亞組分析顯示，幾乎所有亞組均可從「貝莫蘇拜單抗聯合化療後序貫聯合安羅替尼」治療中獲益，其中PD-L1表達1-49%人羣，HR=0.47(95%CI：0.30-0.73)。
試驗組總體安全性良好，試驗組與對照組導致死亡的治療期間不良事件的發生率沒有明顯差異，安全性可控。
解決未滿足臨牀需求，爲sq-NSCLC患者帶來顯著生存獲益
2022年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，其中非小細胞肺癌(NSCLC)佔全部肺癌的80%-85%。sq-NSCLC是NSCLC的主要亞型之一，約佔全部NSCLC的30%。sq-NSCLC患者可接受靶向治療的靶點突變率不足10%，多數患者難以從靶向治療中獲益。
作爲全球首個頭對頭PD-1單抗聯合化療取得陽性結果的隨機雙盲、安慰劑對照的III期臨牀研究，「貝莫蘇拜單抗聯合化療後序貫聯合安羅替尼」方案或將改變現有治療模式，爲臨牀上治療選擇有限的晚期鱗狀非小細胞肺癌患者提供一個創新的一線治療模式。
未來，集團將憑藉自身的創新與商業化能力，推動創新產品加速走向全球市場，造福更多患者，讓「健康科技，溫暖更多生命。」
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
