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Zai Lab To Present Analysis Of The Impact Of Timing For ZEJULA Maintenance Treatment In Newly Diagnosed Advanced Ovarian Cancer At The 2022 International Gynecologic Cancer Society Meeting September 29 - October 1, 2022
Zai Lab To Present Analysis Of The Impact Of Timing For ZEJULA Maintenance Treatment In Newly Diagnosed Advanced Ovarian Cancer At The 2022 International Gynecologic Cancer Society Meeting September 29 - October 1, 2022
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, will present a poster featuring initiation timing analysis from the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy at the upcoming 2022 International Gynecologic Cancer Society (ICGS) Annual Meeting.
This post-hoc analysis of the PRIME Phase 3 study evaluated adults with newly diagnosed advanced ovarian cancer who responded to first-line platinum-based chemotherapy, and they were randomized to receive niraparib maintenance treatment or placebo within 12 weeks after chemotherapy completion. The results are as follows:
- For patients who received niraparib treatment less than 9 weeks after chemotherapy completion, the median progression-free survival (PFS) (95% CI) was measured at 29.4 months with niraparib versus 8.3 months with placebo (HR =0.31; 95% CI, 0.20–0.48).
- For patients who received niraparib at 9 – 12 weeks after chemotherapy completion, the median PFS was 24.7 months with niraparib versus 10.8 months with placebo (HR=0.60; 95% CI, 0.41–0.89).
- The initiation timing of niraparib maintenance treatment had no significant impact on its safety profile.
This subgroup analysis provides evidence to support the initiation of niraparib maintenance treatment in patients with newly diagnosed advanced ovarian cancer within 12 weeks after chemotherapy completion.
"We are excited to be presenting at the 2022 International Gynecologic Cancer Society Annual Meeting showing these results improved clinical efficacy when niraparib maintenance treatment is initiated within 12 weeks after chemotherapy in patients with advanced ovarian cancer," said Alan Sandler, M.D., President and Head of Global Development, Oncology, Zai Lab. "This study further supports ZEJULA as an important maintenance treatment therapy after platinum-based chemotherapy in people with advanced ovarian cancer."
"This PRIME study analysis will help support clinical practice in treating advanced ovarian cancer in China, showing niraparib extended progression-free survival when maintenance treatment begins within 12 weeks after chemotherapy," said Jing Wang, M.D., Director of the Early Clinical Research Center, Hunan Cancer Hospital. "Since a majority of women face recurrence of advanced ovarian cancer after chemotherapy, this study supports niraparib maintenance treatment having a significant clinical benefit in extending progression-free survival compared to placebo."
Details regarding the e-poster presentation at IGCS 2022 are as follows:
Abstract number: 876 Title: Impact of initiation timing of niraparib maintenance treatment in newly diagnosed advanced ovarian cancer Speaker: Jing Wang, M.D., Hunan Cancer Hospital Date: September 29-October 1, 2022 |
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, will present a poster featuring initiation timing analysis from the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy at the upcoming 2022 International Gynecologic Cancer Society (ICGS) Annual Meeting.
上海、舊金山和馬薩諸塞州坎布里奇,9月2022年2月20日(環球通訊社)--再鼎醫藥-SB(納斯達克:ZLAB,香港交易所:9688),是一家以患者為中心、創新、商業階段的全球生物製藥公司,該公司將在即將舉行的2022年國際婦科癌症學會年會上展示一張海報,其中包含ZEJULA(尼拉帕利布)作為維持療法的第三階段主要研究的啟動時機分析。
This post-hoc analysis of the PRIME Phase 3 study evaluated adults with newly diagnosed advanced ovarian cancer who responded to first-line platinum-based chemotherapy, and they were randomized to receive niraparib maintenance treatment or placebo within 12 weeks after chemotherapy completion. The results are as follows:
Prime階段3研究的這項特別後分析評估了對一線鉑類化療有反應的新診斷的晚期卵巢癌成年人,他們被隨機分配到化療完成後12周內接受niraparib維持治療或安慰劑治療。結果如下:
- For patients who received niraparib treatment less than 9 weeks after chemotherapy completion, the median progression-free survival (PFS) (95% CI) was measured at 29.4 months with niraparib versus 8.3 months with placebo (HR =0.31; 95% CI, 0.20–0.48).
- For patients who received niraparib at 9 – 12 weeks after chemotherapy completion, the median PFS was 24.7 months with niraparib versus 10.8 months with placebo (HR=0.60; 95% CI, 0.41–0.89).
- The initiation timing of niraparib maintenance treatment had no significant impact on its safety profile.
- 化療結束後9周內接受尼拉帕利布治療的患者,其中位無進展生存期(PFS)(95%CI)為29.4個月,安慰劑組為8.3個月(HR=0.31;95%CI為0.20~0.48)。
- 在化療結束後9-12周接受尼拉帕利布治療的患者,中位PFS為24.7個月,安慰劑組為10.8個月(HR=0.60;95%CI,0.41-0.89)。
- 尼拉帕利維持治療的開始時間對其安全性沒有顯著影響。
This subgroup analysis provides evidence to support the initiation of niraparib maintenance treatment in patients with newly diagnosed advanced ovarian cancer within 12 weeks after chemotherapy completion.
這一亞組分析提供了證據,支持在化療完成後12周內開始對新診斷的晚期卵巢癌患者進行尼拉帕利維持治療。
"We are excited to be presenting at the 2022 International Gynecologic Cancer Society Annual Meeting showing these results improved clinical efficacy when niraparib maintenance treatment is initiated within 12 weeks after chemotherapy in patients with advanced ovarian cancer," said Alan Sandler, M.D., President and Head of Global Development, Oncology, Zai Lab. "This study further supports ZEJULA as an important maintenance treatment therapy after platinum-based chemotherapy in people with advanced ovarian cancer."
“我們很高興能在2022年國際婦科癌症學會年會上展示這些結果,表明當晚期卵巢癌患者在化療後12周內開始尼拉帕利維持治療時,這些結果提高了臨牀療效,”醫學博士艾倫·桑德勒、總裁和腫瘤學全球發展負責人再鼎醫藥-SB説。這項研究進一步支持ZEJULA作為晚期卵巢癌患者鉑類藥物化療後的一種重要的維持治療方法。“
"This PRIME study analysis will help support clinical practice in treating advanced ovarian cancer in China, showing niraparib extended progression-free survival when maintenance treatment begins within 12 weeks after chemotherapy," said Jing Wang, M.D., Director of the Early Clinical Research Center, Hunan Cancer Hospital. "Since a majority of women face recurrence of advanced ovarian cancer after chemotherapy, this study supports niraparib maintenance treatment having a significant clinical benefit in extending progression-free survival compared to placebo."
湖南腫瘤醫院早期臨牀研究中心董事醫學博士王靜説:“這項優質研究分析將有助於支持中國治療晚期卵巢癌的臨牀實踐,表明當化療後12周內開始維持治療時,尼拉帕利延長了無進展生存期。”由於大多數婦女在化療後面臨晚期卵巢癌的復發,這項研究支持尼拉帕利維持治療與安慰劑相比,在延長無進展存活期方面具有顯著的臨牀益處。“
Details regarding the e-poster presentation at IGCS 2022 are as follows:
關於2022年國際政府間氣候變化大會電子海報介紹的詳情如下:
Abstract number: 876 Title: Impact of initiation timing of niraparib maintenance treatment in newly diagnosed advanced ovarian cancer Speaker: Jing Wang, M.D., Hunan Cancer Hospital Date: September 29-October 1, 2022 |
抽象數: 876 標題尼拉帕利維持治療開始時機對新診斷晚期卵巢癌的影響 揚聲器:王靜,醫學博士,湖南省腫瘤醫院 日期:2022年9月29日-10月1日 |
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.,Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
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