百濟神州(06160.HK)於ASH年會上公佈百悦澤®在SEQUOIA試驗中作為慢性淋巴細胞白血病一線治療的研究結果
格隆匯12月13日丨百濟神州(06160.HK)於2021年12月12日(美國東部時間)公佈SEQUOIA試驗的期中分析結果,這是一項在初治(TN)慢性淋巴細胞白血病(CLL)患者中進行的3期試驗,此次納入分析的數據來自對比百悦澤®和苯達莫司汀聯合利妥昔單抗(B+R治療方案)的隨機佇列1,以及評價百悦澤®聯合維奈克拉治療伴17p染色體缺失(del[17p])和 ╱ 或致病性TP53變異基因的患者的佇列3(D組)。這些數據在第63屆美國血液學會(ASH)年會上進行了兩次口頭報吿。
百濟神州血液學首席醫學官黃蔚娟醫學博士評論道:“在SEQUOIA這項具有積極意義的試驗中,百悦澤®在對比化學免疫療法用於CLL患者一線治療時所呈現出的優效性,印證了高選擇性BTK抑制劑的治療前景。這些強有力的數據以及既往報吿的3期ALPINE試驗的結果都進一步鞏固了我們的信念-百悦澤®能夠成為CLL患者重要的治療新選擇。”
該試驗的主要研究者、澳大利亞Peter MacCallum癌症中心的Constantine Tam教授(內外全科學士、醫學博士)表示:“與化學免疫治療相比,百悦澤®作為一線治療方案,能為CLL患者,包括攜帶未突變的IGHV基因或del(11q)等具有高風險特徵的患者,帶來更優的PFS獲益。SEQUOIA試驗的安全性結果與其他百悦澤®臨牀試驗中報吿的結果相似,房顫的發生率始終較低。基於這些結果,證實百悦澤®這款高選擇性的BTK抑制劑,有望幫助CLL患者帶來無需化療的治療選擇。”
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