榮昌生物(688331.SH):維迪西妥單抗一線治療HER2表達的尿路上皮癌Ⅲ期臨牀研究達到主要研究終點
格隆匯5月12日丨榮昌生物(688331.SH)公佈,自主研發的抗體偶聯藥物(ADC)維迪西妥單抗(代號:RC48,商品名:愛地希)聯合特瑞普利單抗對比化療治療HER2表達的一線局部晚期或轉移性尿路上皮癌的Ⅲ期臨牀研究(RC48-C016)達到無進展生存期(PFS)和總生存期(OS)兩項主要研究終點。RC48-C016研究是一項隨機對照、多中心Ⅲ期臨牀研究,於2022年6月啓動,全國74家臨牀研究中心參與,共入組484例受試者,在既往未接受過系統治療且存在HER2表達(HER2IHC1+、2+或3+)的局部晚期或轉移性尿路上皮癌患者中,對比維迪西妥單抗聯合特瑞普利單抗和吉西他濱聯合順鉑/卡鉑的療效和安全性。
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