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康方生物:自願公告 - PFS HR 0.51, mPFS 11.14個月依沃西單藥對比帕博利珠1L治療PD-L1表達陽性NSCLC (AK112-303/HARMONI -2) III期數據重磅發表於2024 WCLC

HKEX ·  Sep 8 18:32
Summary by Moomoo AI
康方生物科技(開曼)有限公司宣布,其自主研發的PD-1/VEGF雙特異性腫瘤免疫治療藥物依沃西,在一項針對PD-L1表達陽性非小細胞肺癌(NSCLC)的III期臨床試驗中,顯示出顯著的療效。該試驗結果於2024年世界肺癌大會(WCLC)上發表,顯示依沃西單藥治療相較於帕博利珠單藥治療,在整體人群中的中位無進展生存期(mPFS)延長5.3個月,達到11.14個月。此外,依沃西在安全性方面表現良好,並未觀察到出血風險明顯增加。康方生物的合作夥伴SUMMIT亦計劃開展HARMONi-7研究,進一步評估依沃西在一線治療PD-L1高表達轉移性NSCLC的療效。依沃西已於2024年8月獲得中國國家藥品監督管理局受理其新適應症上市申請並納入優先審評。
康方生物科技(開曼)有限公司宣布,其自主研發的PD-1/VEGF雙特異性腫瘤免疫治療藥物依沃西,在一項針對PD-L1表達陽性非小細胞肺癌(NSCLC)的III期臨床試驗中,顯示出顯著的療效。該試驗結果於2024年世界肺癌大會(WCLC)上發表,顯示依沃西單藥治療相較於帕博利珠單藥治療,在整體人群中的中位無進展生存期(mPFS)延長5.3個月,達到11.14個月。此外,依沃西在安全性方面表現良好,並未觀察到出血風險明顯增加。康方生物的合作夥伴SUMMIT亦計劃開展HARMONi-7研究,進一步評估依沃西在一線治療PD-L1高表達轉移性NSCLC的療效。依沃西已於2024年8月獲得中國國家藥品監督管理局受理其新適應症上市申請並納入優先審評。
Akeso Biopharma (Cayman) Limited announced that its independently developed PD-1/VEGF dual-specificity tumor immune therapy drug, Envosi, has shown significant efficacy in a Phase III clinical trial for PD-L1 positive non-small cell lung cancer (NSCLC). The trial results were presented at the 2024 World Conference on Lung Cancer (WCLC), demonstrating that Envosi monotherapy, compared to pembrolizumab monotherapy, extended the median progression-free survival (mPFS) by 5.3 months in the overall population, reaching 11.14 months. In addition, Envosi showed good safety performance without a significant increase in the risk of bleeding. Akeso Biopharma's partner, SUMMIT, also plans to conduct the HARMONi-7 study to further evaluate the efficacy of Envosi in first-line treatment of PD-L1 high-expressing metastatic NSCLC. Envosi has already received acceptance of its new indication marketing application by the China National Medical Products Administration and has been included in priority review since August 2024.
Akeso Biopharma (Cayman) Limited announced that its independently developed PD-1/VEGF dual-specificity tumor immune therapy drug, Envosi, has shown significant efficacy in a Phase III clinical trial for PD-L1 positive non-small cell lung cancer (NSCLC). The trial results were presented at the 2024 World Conference on Lung Cancer (WCLC), demonstrating that Envosi monotherapy, compared to pembrolizumab monotherapy, extended the median progression-free survival (mPFS) by 5.3 months in the overall population, reaching 11.14 months. In addition, Envosi showed good safety performance without a significant increase in the risk of bleeding. Akeso Biopharma's partner, SUMMIT, also plans to conduct the HARMONi-7 study to further evaluate the efficacy of Envosi in first-line treatment of PD-L1 high-expressing metastatic NSCLC. Envosi has already received acceptance of its new indication marketing application by the China National Medical Products Administration and has been included in priority review since August 2024.
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