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百濟神州(688235.SH):將在2022ASH年會上展示ALPINE試驗終期分析結果最新突破摘要

格隆匯11月23日丨百濟神州(688235.SH)公佈,公司將在美國新奧爾良舉行的第64屆美國血液學會(ASH)年會上,就ALPINE試驗的無進展生存期(PFS)終期分析結果進行最新突破摘要的口頭報吿。ALPINE是一項全球3期臨牀試驗,旨在評估百悦澤®(澤布替尼)對比億珂®(伊布替尼)用於治療復發/難治性(R/R)慢性淋巴細胞白血病(CLL)/小淋巴細胞淋巴瘤(SLL)的效果。該結果將於北京時間2022年12月14日凌晨00:15(美國中部時間12月13日上午10:15時)在新奧爾良Ernest N. Morial會議中心E廳進行的最新突破摘要環節上展示。

百悦澤®(澤布替尼膠囊)是一款由公司科學家自主研發的布魯頓氏酪氨酸激酶(BTK)小分子抑制劑,目前正在全球進行廣泛的臨牀試驗項目,作為單藥和與其他療法進行聯合用藥治療多種B細胞惡性腫瘤。百悦澤®的設計通過優化生物利用度、半衰期和選擇性,實現對BTK蛋白靶向、持續的抑制。憑藉與其他獲批BTK抑制劑存在差異化的藥代動力學特徵,百悦澤®已被證明能在多個疾病相關組織中抑制惡性B細胞增殖。

在該試驗最終PFS分析中,經獨立評審委員會(IRC)和研究者評估,百悦澤®對比億珂®取得了優效性結果(分層風險比(HR):0.65[95%置信區間(CI),0.49-0.86],p值=0.0024)。根據IRC和研究者的評估結果,在主要的預定義亞組中,包括在不同IGHV狀態和攜帶del(17p)/TP53突變的患者亞組中,百悦澤®均顯示出一致的PFS優效性。

ALPINE試驗中位隨訪29.6個月時的預設的結果分析顯示,百悦澤®總體耐受性良好,其安全性特徵與既往報吿一致。與伊布替尼(41.2%)相比,百悦澤®組的終止治療總髮生率(26.3%),以及因不良事件(16.2 vs. 22.8%)或疾病進展(7.3 vs. 12.9%)而終止治療的發生率均更低。

與伊布替尼相比,百悦澤®在該分析中的心臟功能相關的安全性指標也展現了優勢:與伊布替尼組(13.3%)相比,百悦澤®組(5.2%)的房顫/房撲發生率較低。伊布替尼組報吿了6例因心臟疾病引起的5級不良事件,而百悦澤®組未有此類不良事件的報吿。

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