百濟神州(688235.SH)：百悦澤®在復發或難治性慢性淋巴細胞白血病/小淋巴細胞淋巴瘤成人患者中展示了優於伊布替尼的總緩解率
格隆匯4月11日丨百濟神州(688235.SH)公佈，公司公佈自主研發產品BTK抑制劑百悦澤®(澤布替尼膠囊)全球性3期臨牀試驗ALPINE研究的最終緩解評估結果。獨立審查委員會確認百悦澤®在復發或難治性慢性淋巴細胞白血病/小淋巴細胞淋巴瘤成人患者中展示了優於伊布替尼的總緩解率。
ALPINE研究是一項隨機、全球性3期臨牀試驗(NCT03734016)，旨在評估百悦澤®對比伊布替尼，用於治療既往經治的復發或難治性(R/R)慢性淋巴細胞白血病(CLL)/小淋巴細胞淋巴瘤(SLL)患者的效果。在此前公佈的ALPINE研究的期中分析中，百悦澤®已在試驗主要終點(即由研究者評估的總緩解率)顯示了優效性。此次最終緩解評估中，百悦澤®也達到了主要終點，在由獨立審查委員會(IRC)評估的總緩解率(ORR)方面展現了相比伊布替尼的優效性。百悦澤®對比伊布替尼，ORR結果分別為80.4%和72.9%(雙側p值=0.0264)。其中，ORR的定義為完全緩解(CR)和部分緩解(PR)數據的總和。ALPINE試驗在全球共入組652例患者，覆蓋歐洲(60%)、美國(17%)、中國(14%)、新西蘭和澳大利亞(9%)等多個國家和地區。試驗的中位隨訪時間為24.2個月。下一步計劃對ALPINE數據進行的分析為無進展生存(PFS)的最終分析。
ALPINE試驗數據顯示，百悦澤®總體耐受性良好，安全性結果與既往研究中的觀察一致。預先指定的安全性分析表明，百悦澤®組的房顫或房撲發生率始終較低。在中位隨訪時間為24.2個月時，百悦澤®組和伊布替尼組的房顫或房撲發生率分別為4.6%(n=15)和12.0%(n=39)。兩個治療組中各有324例患者，其中，百悦澤®組有13.0%(n=42)患者因不良事件終止治療，而這一數值在伊布替尼治療組則為17.6%(n=57)。百悦澤®與伊布替尼組中最常報吿的3級及以上級別不良事件分別為中性粒細胞減少症(14.2% vs. 13.9%)、高血壓(12.7% vs. 10.2%)、感染性肺炎(4% vs. 7.4%)、中性粒細胞計數降低(4.3% vs. 4.0%)、COVID-19 肺炎(4.3% vs. 3.1%)。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
