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百濟神州(06160.HK):百悦澤®(澤布替尼)在對比伊布替尼針對慢性淋巴細胞白血病頭對頭臨牀試驗中期分析中經研究者評估達到客觀緩解率優效性並降低心房顫動或撲動發生概率
格隆匯 04-28 22:41

格隆匯 4 月 28日丨百濟神州(納斯達克代碼:BGNE;香港聯交所代碼:06160)宣佈百悦澤®(澤布替尼)對比伊布替尼用於治療復發或難治性(R/R)慢性淋巴細胞白血病(CLL)或小淋巴細胞淋巴瘤(SLL)患者的ALPINE3期頭對頭臨牀試驗在中期分析中獲得積極結果。

百悦澤®達到上述試驗主要終點,即經研究者和獨立評審委員會(IRC)評估的非劣效客觀緩解率(ORR;p值<0.0001)。經研究者評估,與伊布替尼相比,百悦澤®達到ORR優效性,差異具有統計意義(p值=0.0006);經IRC評估,百悦澤®取得了更高的ORR(p值=0.0121,但對比中期分析預設的嚴格雙邊統計邊界p值<0.0099,未能達到統計意義)。ALPINE3期臨牀試驗已完成全部652例患者入組且正在進行中,該中期分析是在接受至少12個月隨訪的415例患者中開展的。

截至中期分析數據截點,652例患者中的次要終點無進展生存期(PFS)相關數據尚未成熟。然而,PFS的描述性總結數據顯示了有利於百悦澤®的早期趨勢。

同時,該臨牀試驗達到了安全性相關的預先設定次要終點。與伊布替尼相比,百悦澤®在患者中引起心房顫動或撲動事件的風險降低,差異具有統計意義。心房顫動或撲動是一種心律失常的表現,可導致血栓、中風、心力衰竭等其他心血管併發症。總體而言,百悦澤®安全性與先前在其臨牀開發項目中觀察到的數據相符。

ALPINE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。百濟神州血液學首席醫學官黃蔚娟醫學博士表示:"該項頭對頭臨牀試驗中期分析結果表明,與伊布替尼相比,百悦澤®作為一款設計旨在持續、不間斷抑制BTK的高選擇性抑制劑,能為CLL患者在疾病緩解上帶來改善,且降低出現心房顫動或撲動事件的概率。百悦澤®廣泛綜合的臨牀開發項目及該中期分析結果所得數據,均為其效益風險評估提供了有力支援。"

百濟神州計劃與全球藥品監管部門開展溝通交流,並在未來的一場主要醫學會議上公佈試驗數據。ORR將在計劃的最終分析中由IRC再次進行評估,患者隨訪也將繼續開展,用於關鍵次要終點的分析,其中包括PFS。

據悉,慢性淋巴細胞白血病(CLL)是成年人中最常見的一種白血病,在2017年,全球範圍內約有114,000起新增病例。CLL導致患者骨髓中的白細胞及淋巴細胞持續增多,而腫瘤細胞在骨髓中不斷增殖將削弱患者抵抗感染的能力,並能夠進入患者血液,從而浸潤至淋巴結、肝臟、脾臟及身體其它器官。BTK通路是惡性B細胞傳導信號的重要介質,能夠促進CLL發病。小淋巴細胞淋巴瘤(SLL)是一種非霍奇金氏淋巴瘤,主要影響免疫系統中的B淋巴細胞。SLL與CLL相似,但腫瘤細胞主要蓄積於淋巴結中。

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