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復宏漢霖創新型抗EGFR單抗pimurutamab晚期皮膚鱗狀細胞癌II期钻研結果發表於Therapeutic Advances in Medical Oncology Henlius

2026-09-11

近日  ,復宏漢霖自主研發的沉組抗EGFR單克隆抗體pimurutamab (HLX07)  ,針對部门晚期及轉移性皮膚鱗狀細胞癌(CSCC)的II期臨床钻研第一部门結果發表於國際腫瘤專業期刊Therapeutic Advances in Medical Oncology。钻研結果顯示  ,HLX07單藥治療晚期CSCC展現出積極的療效與优良的安全性特徵  ,為在更大的患者人群中進一步索求抗EGFR靶向治療提供了新的循證依據。

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ORR達60.0%  ,展現積極抗腫瘤活性

皮膚鱗狀細胞癌(CSCC)是常見的皮膚惡性腫瘤之一  ,約佔全数皮膚癌的20%  ,且全球發病率持續上升1-2。儘管早期患者可通過手術或放療獲得較好預後  ,但對於無法手術或放療的部门晚期或轉移性患者  ,其10年生计不及20%  ,仍存在進一步優化治療规划的臨床需要1  ,3。


目前  ,晚期CSCC的系統治療重要蕴含免疫治療、化療及抗EGFR靶向治療1  ,4  ,5。儘管免疫治療已成為沉要治療選擇  ,但仍有多數患者無法獲得應答;化療的療效證據則較為有限  ,迄今尚無系統性化療藥物獲批用於晚期CSCC。由於CSCC中EGFR表達廣泛且RAS突變率較低  ,使得EGFR成為潛在的治療靶點6  ,7。然而  ,既往抗EGFR抗體療效有限  ,因而  ,開發療效和安全性更優的抗EGFR靶向療法拥有沉要臨床價值。


HLX07是一款新型全人源抗EGFR單克隆抗體;都韧R床前及早期臨床钻研結果  ,HLX07表現出优良的抗腫瘤活性和安全性  ,並拥有較長的半衰期  ,支持每3週一次給藥。本次發表的II期钻研進一步索求了HLX07單藥治療部门晚期及轉移性CSCC的療效與安全性。


該钻研是一項評估HLX07單藥在晚期CSCC患者中療效與安全性的開放、多中心、兩部门II期臨床試驗。本次報路第一部门的結果。钻研入組了伴有淋巴結轉移或遠端轉移的晚期CSCC或無法進行手術/無法進行根治性放療的部门晚期CSCC患者。截至2024年4月30日  ,共入組31例患者  ,絕大多數患咏―移性CSCC  ,其中1500 mg組(A組)21例、1000 mg組(B組)10例。B組中60%的患者既往接受過系統性抗腫瘤治療。钻研重要終點為盲態獨立中心審查委員會(BICR)評估的客觀緩解率(ORR)  ,次要終點蕴含無進展生计期(PFS)、總生计期(OS)、緩解持續時間(DOR)、疾病节造率(DCR)、至緩解時間以及安全性、藥代動力學、免疫原性和生涯質量等  ,並索求療效與腫瘤EGFR及PD-L1表達水平之間的相關性。


長期隨訪數據展現出優異的抗腫瘤活性與生计獲益:基於BICR評估  ,A組中  ,經確認的ORR為19.0%  ,均為部门緩解(PR);B組中經確認的ORR達到60.0%  ,其中蕴含1例齐全緩解(CR)。DCR分別為61.9%和100%。A組和B組的PFS分別為4.9個月和7.9個月  ,DOR分別為5.0個月和7.4個月  ,OS分別為11.8個月和未達到。

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优良耐受性與安全性  ,索求最佳給藥劑量

HLX07單藥安全性可控  ,未發現新的安全性信號。钻研支持1000 mg作為HLX07進一步臨床評價的劑量水平  ,後續钻研也將進一步驗證其在晚期CSCC患者中的臨床獲益  ,並索求EGFR蛋白表達與治療獲益之間的關係。

PG国际-创造和传布娱乐领域的美好履历游戏平台


聚焦未滿足臨床需要  ,索求更多腫瘤治療可能

EGFR在多種實體瘤中普遍高表達  ,蕴含非鱗狀和鱗狀非幼細胞肺癌  ,被認為是腫瘤發生、進展及耐藥的沉要驅動成分8。值妥贴心的是  ,EGFR高表達與EGFR敏感突變並不等同  ,二者之間的相關性較低9。尤其在sqNSCLC人群中  ,經典敏感性EGFR突變更為罕見10。這意味著  ,多數EGFR高表達的鱗癌患者並不攜帶敏感性EGFR突變  ,因而難以從EGFR-TKI類靶向藥中獲益10。儘管近年來  ,抗EGFR單抗聯合化療在肺鱗癌等疾病的治療中展現出肯定的臨床獲益基礎11  ,12  ,以PD-1/PD-L1抑造劑為基礎的免疫聯合化療也顯著改善了晚期肺鱗癌的一線治療結局  ,但整體療效仍有提升空間  ,臨床上仍亟需新的聯合治療战术13-23。


從單藥治療到聯合免疫治療、化療及ADC  ,HLX07正通過多元聯合战术進一步索求其在EGFR高表達實體瘤中的治療潛力。 目前  ,HLX07聯合抗PD-1單抗H藥 漢斯狀?(斯魯利單抗  ,歐洲商品名:Hetronifly?)及化療一線治療晚期鱗狀非幼細胞肺癌(sqNSCLC)患者的II/III期臨床钻研已在中國实现首例患者給藥  ,並在澳大利亞实现臨床試驗備案(CTN)。此表  ,公司自主研發的創新型法式性殒命配體1(PD-L1)抗體偶聯藥物(ADC)HLX43聯合HLX07治療晚期/轉移性實體瘤的Ib/II期臨床钻研已獲中國國家藥品監督治理局(NMPA)核准。


未來  ,復宏漢霖將繼續秉持「以患者為中心」的初心和理想  ,通過不斷挖掘患者未滿足的臨床需要  ,持續夯實更多創新分子的差異化佈局  ,為更多腫瘤患者帶來高質量、可負擔的新型治療规划。



参考文件

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