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貝達藥業(300558.SZ):鹽酸恩沙替尼eXalt3研究期中分析結果發佈
格隆匯 08-09 19:04

格隆匯 8 月 9日丨貝達藥業(300558.SZ)發佈公告,2020年8月8日,公司和控股子公司Xcovery Holdings, Inc.(以下簡稱“Xcovery公司”)共同研發的新一代ALK抑制劑鹽酸恩沙替尼(Ensartinib、X-396)國際多中心Ⅲ期臨牀研究(eXalt3)期中分析結果在世界肺癌大會(IASLC WCLC)主席團研討會上發佈。結果顯示,接受恩沙替尼治療的ALK陽性非小細胞肺癌(NSCLC)患者,其中位無進展生存期(mPFS)顯著長於接受克唑替尼治療的患者。

恩沙替尼eXalt3研究共入組290例ALK陽性NSCLC患者,被隨機分配到恩沙替尼或克唑替尼治療組。截至2020年7月1日數據,經盲態獨立評審委員會(BIRC)評估,進展事件佔最終分析預設進展事件的73%。數據表明,接受恩沙替尼治療組的中位無進展生存期(mPFS)為25.8個月,接受克唑替尼治療組的為12.7個月,兩者具有顯著性統計學差異。生存分析(K-M曲線)顯示,在治療後36個月時間點,恩沙替尼組只有不到40%患者進展,而克唑替尼組有75%的患者進展。目前,eXalt3研究還將繼續跟進正在接受治療的患者。

綜上,在ALK陽性非小細胞肺癌患者中,恩沙替尼顯著延長無進展生存期,具有良好的安全性,是一線治療的新選擇。基於該eXalt3研究結果,公司將積極準備中美一線適應症的上市申報,恩沙替尼將成為公司第一個在全球上市的創新藥。

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