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基石藥業-B(02616.HK):ivosidenib橋接註冊性I期臨牀試驗完成首例患者給藥
格隆匯 11-20 06:18

格隆匯11月20日丨基石藥業-B(02616.HK)公佈,ivosidenib(TIBOSOVO®)在中國的橋接註冊性I期臨牀試驗完成首例患者給藥。該項獨立試驗旨在驗證ivosidenib在異檸檬酸脱氫酶-1(「IDH1」)基因突變的復發或難治性(「R/R」)急性髓系白血病(「AML」)患者中的有效性、安全性和藥代動力學。

目前,針對新診斷AML患者的標準治療主要為在強化誘導化療(IC) 後,給予包括異體造血幹細胞移植(Allo-HSCT) 在內的鞏固治療,以實現長期治癒的目的。在接受該種治療方案的患者中,約35%至40%可以達到完全緩解,但僅有約25%的患者能實現3年以上生存。大部分AML患者會對治療產生耐藥或最終復發,發展為R/R AML,後續臨牀治療難度極大,且國際上尚無標準治療方案。隨着基因測序技術的出現,基因突變分析為AML治療帶來了新的機遇與挑戰。在所有AML病例中,約有6%至10%與IDH1突變有關。

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