百濟神州(06160.HK)：在美國血液學會(ASH)最新突破摘要口頭報吿中展示百悦澤® (澤布替尼)對比億珂®(伊布替尼)在治療慢性淋巴細胞白血病患者中所取得的無進展生存期(PFS)優效性結果
格隆匯12月14日丨百濟神州(06160.HK)發佈公吿，公司於2022年12月13日公佈了其ALPINE 試驗的最終PFS分析結果：在這項針對復發╱難治性(R/R)慢性淋巴細胞白血病 (CLL)╱小淋巴細胞淋巴瘤(SLL)患者的全球3期試驗中，百悦澤®對比億珂®取得了優效性結果，表現出更具優勢的心臟功能相關的安全性特徵。這些數據在新奧爾良舉辦的第64屆美國血液學會(ASH)年會上通過最新突破摘要的口頭報吿(摘要編號LBA-6)進行展示，並同時刊載於《新英格蘭醫學雜誌》。論文的主要作者、美國丹娜法伯(Dana-Farber)癌症研究院血液腫瘤分部CLL中心主任Jennifer Brown 醫學博士在大會上進行口頭報吿。
Brown博士表示：“PFS是在CLL臨牀試驗中衡量有效性的金標準。在包括攜帶 del(17p)/TP53突變的高風險患者的所有主要亞組中，ALPINE試驗數據展示了百悦澤®的優效性和臨牀獲益的一致性，同時表現出更具優勢的心臟功能相關的安全性特徵。試驗數據有力地證明了百悦澤®是一款足以改變CLL患者治療格局的布魯頓氏酪氨酸激酶(BTK)抑制劑。”
百濟神州血液學首席醫學官Mehrdad Mobasher醫學博士及公共衞生碩士表示：“百悦澤®經過特殊的結構設計，能夠最大化對BTK靶點的佔有率、最小化脱靶效應。我們的臨牀研發項目旨在檢測百悦澤®區別於其他藥物的有效性和安全性特徵。我們認為ALPINE試驗中百悦澤®的PFS數據和心臟功能相關的安全性結果(包括未報吿心源性死亡事件)表明百悦澤®對改善CLL患者的治療結果有實質性意義。”
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