百濟神州(06160.HK)：替雷利珠單抗治療一線不可切除肝細胞癌的全球3期試驗取得積極結果
格隆匯8月9日丨百濟神州(06160.HK)公吿，於2022年8月9日，替雷利珠單抗(中文商品名：百澤安®)全球3期臨牀試驗RATIONALE301研究達到主要終點，在治療一線不可切除的肝細胞癌(HCC)成人患者中，替雷利珠單抗與索拉非尼相比，展示出在總生存期(OS)上的非劣效性，其安全性特徵與既往研究一致，未報吿新的安全性警示。該研究入組了來自美國、歐洲和亞洲的600餘名患者。
HCC是全球第六大常見癌症類型，2020年i新發病例超過900,000例，儘管在篩查、監測方法和影像學方面均已取得進步，仍有超過三分之二的HCC患者在診斷時已處於疾病晚期ii。
"不可切除的肝細胞癌患者預後極為不理想，中位預期生存期僅為一年。如果患者對TKI治療不耐受或病情發生進展，則目前的治療選擇所剩無幾。"百濟神州實體瘤首席醫學官Mark Lanasa醫學博士表示，"RATIONALE301試驗的這一結果讓公司備受鼓舞，公司期待在即將召開的學術會議上分享完整的安全性和有效性數據。"
RATIONALE 301(NCT03412773)是一項隨機、開放性的全球3期臨牀研究，旨在評估替雷利珠單抗對比索拉非尼，作為一線治療不可切除的HCC成人患者的效果。此研究的主要終點是兩個治療組總生存期(OS)的非劣效性比較。關鍵次要終點是盲態獨立審查委員會(BIRC)根據RECIST1.1版評估的總緩解率(ORR)。其他次要終點包括有效性評估(如根據BIRC評估的無進展生存期、緩解持續時間和至疾病進展時間)和健康相關生活品質指標，以及安全性與耐受性。
替雷利珠單抗(中文商品名：百澤安®)是一款人源化IgG4抗程式性死亡受體－1(PD-1)單克隆抗體，其結構經特殊改造，可最大限度減少與巨噬細胞上Fcγ受體的結合，幫助人體免疫細胞識別並殺傷腫瘤。臨牀前研究表明，抗體與巨噬細胞上Fcγ受體結合會啟動抗體依賴細胞介導的吞噬作用，殺傷效應T細胞，從而降低PD-1抗體的抗腫瘤活性。
替雷利珠單抗是百濟神州免疫腫瘤生物藥平台的第一款研發藥物，目前正進行單藥及聯合療法臨牀試驗，以開發一系列針對實體瘤和血液腫瘤的廣泛適應症。
替雷利珠單抗全球臨牀開發項目已在30個國家和地區入組超過11,000例受試者。百濟神州已開展或完成了超過22項替雷利珠單抗的潛在註冊性臨牀試驗。
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