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中國生物製藥(01177.HK):TQB2868“PD-1/TGF-β雙功能融合蛋白”II期研究數據在2025年ASCO年會公佈

格隆匯5月29日丨中國生物製藥(01177.HK)公告,集團已在2025年美國臨牀腫瘤學會(ASCO)年會公佈了TQB2868「PD-1/TGF-β雙功能融合蛋白」聯合安羅替尼與化療一線治療轉移性胰腺導管腺癌(mPDAC)的II期臨牀研究初步數據。

TQB2868-ALTN-II-01是一項評估TQB2868聯合安羅替尼與AG化療(吉西他濱+白蛋白結合型紫杉醇)一線治療mPDAC的有效性和安全性的II期臨牀研究。

截至2025年1月,該研究已入組40例IV期mPDAC患者,其中36例可評估,初步數據顯示:TQB2868聯合安羅替尼與AG化療的客觀緩解率(ORR)達63.9%,爲AG化療方案歷史數據(23%-36%)的2-3倍;疾病控制率(DCR)達100%,是AG化療方案(62.3%)的1.6倍;中位無進展生存期(PFS)尚未達到,6個月PFS率達86%,是AG化療方案(43.2%)的2倍;中位總生存期(OS)尚未達到,預期有望超過1年。

在安全性方面,TQB2868聯合方案安全耐受性良好,3級及以上不良反應發生率爲52.5%(AG化療方案爲68.1%-77%)。

集團正在就TQB2868聯合方案的註冊III期臨牀試驗與中國國家藥品監督管理局藥品審評中心(CDE)進行溝通。該方案有望成爲免疫檢查點抑制劑在胰腺癌的首個一線治療方案,爲胰腺癌患者的總生存期、生活質量帶來根本性改善。

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