頭對頭獲勝!澤布替尼CLL/SLL頭對頭3期研究達到主要終點
2021年4月28日,百濟神州(06160.HK)宣佈BTK抑制劑百悦澤®(澤布替尼)對比伊布替尼用於治療成年復發或難治性(R/R)慢性淋巴細胞白血病(CLL)/小淋巴細胞淋巴瘤(SLL)患者的頭對頭全球3期臨牀試驗在中期分析中取得積極結果,達到療效主要終點及安全性相關的次要終點,再次證明了澤布替尼作為一款新型的高選擇性BTK抑制劑,為患者帶來了更高的療效與安全性。
經研究者評估,與伊布替尼相比,百悦澤®在客觀緩解率(ORR)上取得了優效性,同時,該臨牀試驗達到了安全性相關的預先設定次要終點,在患者中引起房顫的風險更低,差異具有統計意義。對於CLL/SLL這類在老年人中多發的淋巴瘤而言,房顫可引發血栓、中風、心衰,以及其他心臟相關的併發症。這項頭對頭研究的數據表明,百悦澤®相比伊布替尼,在療效和和安全性方面都取得了改善。
百悦澤®是目前全球唯一一款在針對兩項血液惡性腫瘤的治療中,開展頭對頭臨牀試驗以評估療效和安全性的BTK抑制劑,也是我國首個與外資藥企進口藥物開展頭對頭3期優效性試驗的本土研發抗癌新藥。通過頭對頭試驗的直接對比,能夠為醫生和患者在疾病治療方面提供清淅直接的證據。
ALPINE研究是百濟神州開展的第二項百悦澤®對比伊布替尼的3期頭對頭臨牀試驗,目前已完成652例患者入組並正在進行中,這項中期分析是在接受至少12個月隨訪的415例患者中開展的。該試驗的ORR將在計劃的最終分析中由IRC再次進行評估,並繼續開展患者隨訪,用於無進展生存期(PFS)等關鍵次要終點的分析。雖然截至中期分析數據位點,652例患者中的次要終點PFS相關數據尚未成熟,但PFS的描述性總結數據已經顯示了有利於百悦澤®的早期趨勢。
同時,百濟神州將與全球藥品監管部門開展溝通,並在未來的一場主要醫學會議上公佈試驗數據。
作為我國首個出海的本土新藥,百悦澤®當前已經在美國、中國、阿聯酋、加拿大獲批,並同時被納入美國NCCN指南與中國CSCO臨牀指南,作為治療套細胞淋巴瘤(MCL)、CLL/SLL的優先推薦方案之一。除中美以外,百悦澤®已在全球遞交超過30項相關上市申請,覆蓋超過40個國家或地區,進一步拓展全球化步伐。
在中國,百悦澤®在2020年6月獲批上市,用於治療既往至少接受過一種治療的MCL、CLL/SLL患者。在上市當年,這兩項適應症即被快速納入新版國家醫保目錄,以更可負擔的惠民價格,讓這款具備國際品質的治療方案惠及我國廣大患者。
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