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首藥控股(688197.SH):SY-3505在ALK陽性NSCLC患者中具有良好的耐受性
格隆匯 06-06 09:46

格隆匯6月6日丨有投資者向首藥控股(688197.SH)提問:關於ASCO年會上公司披露的數據。公司如何解讀SY-3505的臨牀數據?與勞拉替尼相比如何看待SY-3505的競爭優勢?

首藥控股回覆:截至2023年2月,600mg劑量下入組56名患者(其中,2名患者僅使用過一種非阿來替尼的第二代ALK-TKI治療,22名患者僅使用過阿來替尼一種ALK-TKI治療,32名患者接受過2種及以上ALK-TKIs治療),47名患者至少做過一次療效評估,初步的ORR和DCR分別為38.3%和83.0%。中位DoR和PFS尚未達到。其中,針對22例基線有中樞神經系統轉移的患者,ORR和DCR分別為50.0%和86.4%。

上述ORR為經研究者評估(非經獨立評審委員會/IRC評估)的客觀緩解率,數據截止時間為今年2月。由於彼時部分患者僅做過一次療效評價,尚未達到最佳效果,隨着後續隨訪時間的增加,我們也期待數據發生向好的變化。

從安全性數據可以看到,32名(57.1%)患者經歷了治療相關不良事件(TRAE),2名(3.6%)患者的TRAE等級≥3級。最常見的TRAE是腹瀉(42.9%)、噁心(28.6%)和嘔吐(26.8%),表明SY-3505在ALK陽性NSCLC患者中具有良好的耐受性,這也是SY-3505的一大競爭優勢。

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