GSK Raises Prospects For Withdrawn Blood Cancer Drug Blenrep To Return To US Market - Here's Why
GSK Raises Prospects For Withdrawn Blood Cancer Drug Blenrep To Return To US Market - Here's Why
On Thursday, GSK plc (NYSE:GSK) released headline results from a planned interim analysis of the DREAMM-7 head-to-head phase 3 trial of Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma.
週四，GSK plc (紐交所:GSK)發佈了DREAMm-7頭對頭第3期試驗的計劃中期分析的主要結果，該試驗評估了Blenrep (belantamab mafodotin)與硼替佐米和地塞米松 (BorDex)聯合作爲複發性或難治性多發性骨髓瘤的第二線或更晚治療方案。
The trial met the key secondary endpoint of overall survival (OS), showing that belantamab mafodotin when combined with BorDex significantly reduced the risk of death versus standard of care daratumumab plus BorDex.
該試驗達到了整體生存期(Overall Survival, OS)的關鍵次要終點，顯示belantamab mafodotin與BorDex聯合相比標準護理達拉魯單（daratumumab）加上BorDex顯著降低了死亡風險。
The interim analysis results, including safety data, will be presented at the upcoming American Society of Hematology Annual Meeting and Exposition.
包括安全數據在內的中期分析結果將在即將舉行的美國血液學年會上進行展示。
Also Read: GSK's Q3 Earnings Hit By Lower Than Expected Vaccine Sales, Cautions Lower Revenue For 2024
此外閱讀：GSK第三季度營業收入受到低於預期生物-疫苗銷售的影響，警告2024年營業收入下滑。
A phase 3 study in newly diagnosed transplant-ineligible multiple myeloma is expected to be initiated by the end of 2024 as part of the DREAMM program.
預計在2024年底之前將啓動一項新診斷的無法接受移植的多發性骨髓瘤第3期研究，作爲DREAMm計劃的一部分。
In 2024, belantamab mafodotin combinations have been filed in the U.S., European Union, Japan, United Kingdom, Canada, and Switzerland for relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials.
2024年，基於DREAMm-7和DREAMm-8試驗的結果，belantamab mafodotin聯合療法已在美國、歐盟、日本、英國、加拿大和瑞士提交，用於難治性或複發性多發性骨髓瘤。
In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
2022年，GSK基於先前宣佈的DREAMm-3第3期確證試驗的結果，根據FDA的加速批准規定，接受了FDA的要求，撤銷了Blenrep在美國的市場授權。
In June, GSK released results from an interim analysis of the DREAMM-8 phase 3 head-to-head trial of Blenrep in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex for relapsed or refractory multiple myeloma.
6月，GSK發佈了DREAMm-8頭對頭第3期試驗的中期分析結果，比較了Blenrep與潑替康胺和地塞米松(PomDex)聯合和標準護理硼替佐米加PomDex在複發性或難治性多發性骨髓瘤中的療效。
On the primary endpoint of progression-free survival (PFS), the belantamab mafodotin combination (n=155) showed a statistically significant and clinically meaningful improvement compared to the bortezomib combination (n=147).
在無疾病進展生存期主要終點上，belantamab mafodotin聯合療法(n=155)與bortezomib聯合療法(n=147)相比，顯示出統計學上顯著且臨床上有意義的改善。
Price Action: GSK stock is down 0.01% at $35.11 at the last check on Thursday.
股價走勢：週四最後一次查詢時，GSK股票下跌0.01%，報35.11美元。
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譯文內容由第三人軟體翻譯。
