科濟藥業-B(02171.HK)於醫學年會發表澤沃基奧侖賽注射液研究結果
科濟藥業-B(02171.HK)公布,在2023年美國血液學會(ASH)年會上,公司展示一篇關於澤沃基奧侖賽注射液(zevor-cel,研發代號CT053)研究結果的海報,報告在中國的I/II期註冊臨床研究(LUMMICAR-1,NCT03975907)I期臨床試驗的3年隨訪療效和安全性的結果。
澤沃基奧侖賽注射液是一種含有B細胞成熟抗原(BCMA)的自體全人抗嵌合抗原受體(CAR)T細胞治療產品,目前正開發用於治療復發或難治性多發性骨髓瘤(R/R MM)的患者。LUMMICAR STUDY 1試驗是在中國進行的一項多中心、開放標籤I/II期臨床試驗。基於I/II期臨床試驗的中國新藥上市申請正在審批過程中。
臨床試驗中對既往經多重治療的R/R MM人群進行為期3年的隨訪,結果顯示澤沃基奧侖賽注射液具有令人鼓舞的安全性,其深度和持久的反應與初步結果一致。
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