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6-K: Gsk Announces First Trial Met Its Primary Endpoint of Progression Free Survival in First Line Advanced Ovarian Cancer

6-K: Gsk Announces First Trial Met Its Primary Endpoint of Progression Free Survival in First Line Advanced Ovarian Cancer

6-K:Gsk宣佈首項臨牀試驗達到一線晚期卵巢癌無進展生存期的主要終點
美股SEC公告 ·  12/20 23:30

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GSK announced positive results from the FIRST-ENGOT-OV44 phase III trial evaluating Zejula and Jemperli in first-line advanced ovarian cancer. The trial met its primary endpoint, demonstrating statistically significant progression-free survival (PFS) improvement with dostarlimab added to standard chemotherapy and niraparib maintenance, with or without bevacizumab.The key secondary endpoint of overall survival did not reach statistical significance. Safety profiles were consistent with known profiles of individual agents. Full results will be shared with health authorities and presented at an upcoming scientific meeting.The FIRST trial, an international phase III study led by GINECO, investigated dostarlimab's addition to standard platinum-based chemotherapy and niraparib maintenance in stage III or IV nonmucinous epithelial ovarian cancer. This study aligns with GSK's focus on gynaecological cancers and its commitment to advancing oncology treatments.
GSK announced positive results from the FIRST-ENGOT-OV44 phase III trial evaluating Zejula and Jemperli in first-line advanced ovarian cancer. The trial met its primary endpoint, demonstrating statistically significant progression-free survival (PFS) improvement with dostarlimab added to standard chemotherapy and niraparib maintenance, with or without bevacizumab.The key secondary endpoint of overall survival did not reach statistical significance. Safety profiles were consistent with known profiles of individual agents. Full results will be shared with health authorities and presented at an upcoming scientific meeting.The FIRST trial, an international phase III study led by GINECO, investigated dostarlimab's addition to standard platinum-based chemotherapy and niraparib maintenance in stage III or IV nonmucinous epithelial ovarian cancer. This study aligns with GSK's focus on gynaecological cancers and its commitment to advancing oncology treatments.
GSk宣佈了FIRSt-ENGOt-OV44的第三階段試驗的積極結果,該試驗評估了Zejula和Jemperli在一線晚期卵巢癌中的應用。該試驗達到了其主要終點,顯示出在標準化療和niraparib維持治療中加入dostarlimab的統計學顯著生存無進展期(PFS)改善,伴或不伴有貝伐珠單抗。整體生存的關鍵二級終點未達到統計學顯著性。安全性特徵與已知的單獨藥物特徵一致。完整結果將與衛生當局分享,並在即將舉行的科學會議上進行報告。FIRSt試驗是由GINECO領導的國際第三階段研究,調查了dostarlimab加入標準鉑類化療和niraparib維持治療在III期或IV期非粘液性上皮卵巢癌中的應用。該研究與GSK對婦科癌症的關注以及推進腫瘤學治療的承諾相一致。
GSk宣佈了FIRSt-ENGOt-OV44的第三階段試驗的積極結果,該試驗評估了Zejula和Jemperli在一線晚期卵巢癌中的應用。該試驗達到了其主要終點,顯示出在標準化療和niraparib維持治療中加入dostarlimab的統計學顯著生存無進展期(PFS)改善,伴或不伴有貝伐珠單抗。整體生存的關鍵二級終點未達到統計學顯著性。安全性特徵與已知的單獨藥物特徵一致。完整結果將與衛生當局分享,並在即將舉行的科學會議上進行報告。FIRSt試驗是由GINECO領導的國際第三階段研究,調查了dostarlimab加入標準鉑類化療和niraparib維持治療在III期或IV期非粘液性上皮卵巢癌中的應用。該研究與GSK對婦科癌症的關注以及推進腫瘤學治療的承諾相一致。
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