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百濟神州(06160.HK):百澤安®食管鱗狀細胞癌全球3期臨牀試驗獲得積極主要結果
格隆匯 01-28 08:06

格隆匯 1 月 28日丨百濟神州(06160.HK)發佈公吿,百濟神州於美國東部時間2021年1月27日宣佈其用於評估抗PD-1抗體百澤安® (替雷利珠單抗)對比研究者選擇的化療用於治療既往接受過全身療法的晚期不可切除或轉移性食管鱗狀細胞癌(ESCC)的 RATIONALE 302全球3期臨牀試驗達到總生存期(OS)這一主要終點。試驗結果表明,針對意向治療人羣(ITT),百澤安®在總生存期中取得了具有統計和臨牀意義的提高。百澤安®的安全性數據與已知風險相符,未出現新的安全警示。

百濟神州腫瘤免疫學首席醫學官賁勇醫學博士評論道:“我們非常興奮在又一項 3期臨牀試驗中觀察到,與標註療法化療相比,百澤安®能為患者帶來總生存期獲益。這是百澤安®公佈的第四項,同時也是首項在包括肝癌、胃癌和食管癌在內的廣泛的胃腸道臨牀項目中獲得積極結果的3期臨牀試驗。百濟神州目前正在多個瘤種中對百澤安®進行評估,也將從中獲得更多臨牀證據,我們期待能為全球患者帶來這款具有潛在差異化的抗PD-1抗體。百濟神州計劃就RATIONALE 302試驗結果與全球範圍內多個監管部門開展溝通,並於接下來的一場醫療會議中公佈數據。

北京大學腫瘤醫院副院長兼該試驗主要研究者沈琳教授表示:“管癌通常疾病進展快、死亡率高,是目前存在高度未被滿足的醫療需求的疾病。近年來,隨着免疫療法逐漸取代化療和放療,針對晚期食管鱗癌的治療也出現了質的變化。 RATIONALE 302試驗取得了陽性結果,也表明百澤安®有望為罹患這一重疾的人羣帶來一項新的療法,為這些患者和家屬帶來希望。

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