和譽(02256.HK)治療尿路上皮癌臨牀患者具良好耐受性
和譽-B(02256.HK)公佈,其附屬和譽醫藥在內地針對伴有FGFR2或FGFR3變異的尿路上皮癌患者開展的其正在研究的泛FGFR抑制劑Fexagratinib (ABSK091)初步II期的療效及安全性結果。
初步療效結果顯示,經獨立評審委員會(IRC)確認,伴有FGFR3變異(包括突變及/或融合)的轉移性尿路上皮癌患者的客觀緩解率爲30.7% (4/13),且經IRC確認,伴有FGFR3突變的患者的客觀緩解率爲44% (4/9),這與先前在中國境外類似患者組中進行的Fexagratinib (ABSK091)的BISCAY試驗結果一致。
初步安全性結果顯示,80mg每日兩次的Fexagratinib (ABSK091)在中國患者中具有良好的耐受性,且沒有任何與藥物相關的4級或以上不良反應報告。該等結果支持Fexagratinib (ABSK091)在進行的II期試驗中進一步開發。
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