基石藥業-B(02616.HK):《新英格蘭醫學雜誌》重磅發表AGILE III期AML研究數據
格隆匯4月22日丨基石藥業-B(02616.HK)發佈公吿,《新英格蘭醫學雜誌》發表了拓舒沃®(艾伏尼布片)AGILE III期臨牀研究結果。AGILE研究是一項全球III期、多中心、雙盲、隨機、安慰劑對照的臨牀試驗,旨在評估拓舒沃®聯合阿扎胞苷相較於安慰劑聯合阿扎胞苷在先前未經治療的異檸檬酸脱氫酶-1(“IDH1”)突變急性髓系白血病(“AML”)患者中的療效和安全性。 AGILE研究達到了主要研究終點和包括總生存期(“OS”)在內的所有關鍵次要終點。施維雅公司正在積極與包括美國食品藥品監督管理局(“FDA”)在內的多個國家和地區的藥品監督管理部門就拓舒沃®該新適應症上市申請展開溝通。基石藥業計劃在中國遞交拓舒沃®該適應症的新藥上市申請。
AML是一種進展迅速的血液和骨髓癌症,是成人白血病中最常見的類型。在美國,每年約有 20,000例新發病例。在中國,每年約有7.53萬白血病新發病例,其中AML患者的佔比約為 59%。大多數AML患者最終會復發。復發或難治性AML患者的預後通常較差。患者五年生存率約29.5%。在被診斷為急性髓細胞白血病的患者中,約6~10%攜帶IDH1突變。
基石藥業首席醫學官楊建新博士表示:“我們非常高興地看到AGILE III期AML研究優異數據在《新英格蘭醫學雜誌》發表,這充分彰顯了全球權威學術期刊對該研究結果和學術價值的高度認可。IDH1突變AML患者的預後差,尤其是IDH1突變的未經強化化療的初治AML患者。拓舒沃®聯合阿扎胞苷療法將有望為這部分患者帶來新的治療選擇。我們計劃與中國國家藥品監督管理局(“NMPA”)展開溝通,期待儘快將這一創新療法帶給更多中國患者。”
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