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復宏漢霖-B(02696.HK):HLX02與原研曲妥珠單抗在HER2陽性轉移性乳腺癌患者上的療效、安全性和藥代動力學相當
格隆匯 09-17 18:13

格隆匯 9 月 17日丨復宏漢霖-B(02696.HK)宣佈,今日,公司自主開發的HLX02注射用曲妥珠單抗(中國境內商品名:漢曲優;歐盟商品名:Zercepa)("HLX02")的最新臨牀研究數據以電子海報形式於2020年歐洲腫瘤內科學會("ESMO")大會線上平台發佈,該等臨牀研究數據亦將於近期召開的2020年第十二屆歐洲乳腺癌大會("EBCC")上發表。

一項比較曲妥珠單抗生物類似藥候選藥HLX02與曲妥珠單抗在轉移性乳腺癌中的療效、安全性及藥代動力學特性的全球3期臨牀試驗

(A) 試驗設計

在多中心、隨機、雙盲、平行對照的 3 期 臨 牀 試 驗( 臨 牀 試 驗 號 :NCT03084237;歐洲臨牀試驗號:2016-000206-10)HLX02-BC01中,未經系統治療的HER2陽性復發或轉移性乳腺癌患者按1:1隨機分為兩組,分別接受每三週一次,最長一年的HLX02或歐盟市售曲妥珠單抗聯合多西他賽治療。本試驗主要療效終點為8個治療週期後即24周的總緩解率(ORRwk24)。羣體藥代動力學(PopPK)數據(HLX02組:356例;原研曲妥珠單抗組:398例;血清樣本5,882份)來源於HLX02-BC01試驗和HLX02-HV01(臨牀試驗號:NCT02581748)試驗,採用非線性混合效應模型(NONMEM?)中考慮到交互作用的一級擬合方法(FOCEI)進行建立。為評估藥代動力學(PK)與藥效學(PD)的相關性,重要協變量(如人口統計、病理生理╱疾病狀況等)被納入模型分析。基於篩選後的協變量,我們進行了1000次模擬檢驗。

(B) 試驗結果

1) 有效性

a) 主要終點

本試驗入組了649例病患(HLX02,N=324;EU-TZB,N=325)。在意向性分析集中,HLX02組的ORRwk24為71.3%,原研組為71.4%,組間差異為-0.1%(95%置信區間:-7.0%,6.9%)。在符合方案集中,HLX02組的ORRwk24為74.2%,原研組為73.2%,組間差異為1%(95%置信區間:-6.0%,7.9%)。ORRwk24組間差異在預設等效區間內(±13.5%)。此外,亞組(亞洲vs.非亞洲,中國vs.非中國)分析顯示,HLX02組與原研組ORRwk24在不同人羣中無統計學差異(p>0.05),驗證了HLX02與原研曲妥珠單抗的療效相似性。

b) 次要終點

兩治療組的次要療效終點如臨牀獲益率(CBR)、疾病控制率(DCR)、緩解持續時間(DoR)、無進展生存期(PFS)、總生存期(OS)等,均無統計學差異(p>0.05)。

2) 安全性

HLX02和原研曲妥珠單抗安全性(包括藥物相關的心臟疾病的發生率)相似

3) 羣體藥代動力學

此PopPK模型為具有一級消除速率的二室模型。結果顯示,HLX02與不同來源曲妥珠單抗的穩態暴露量沒有顯着差異(AUCss和Cmax,ss差別均小於等於13%)。協變量(例如體重)對於HLX02與不同來源曲妥珠單抗的藥代動力學暴露量的影響也具有相似性。

(C) 結論

3期臨牀試驗及PopPK模型結果顯示,HLX02與原研曲妥珠單抗在HER2陽性轉移性乳腺癌患者上的療效、安全性和藥代動力學相當。HLX02作為首個獲批的中國製造的曲妥珠單抗生物類似藥,將為全球患者提供替代治療的選擇。

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