格雷-lyu 的讨论

发布于: 雪球回复:0喜欢:2
和黄这个本身OS就是没有作为主要终点吧???
但康宁这个OS是作为主要终点的,如果未达到,那获批的概率很低。
KN046-301
Primary Outcome Measures :
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging [ Time Frame: up to 2 years]PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Overall Survival (OS) [ Time Frame: up to 3 years ]
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.

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2023-05-19 09:20

和黄路子野啊,双终点一个没达到都能提交申请,信达那个是单终点,os是次要终点

反正比较难以理解。。。

再退一步讲,就FDA对于PARP一系列的严格退市或者缩窄适应症的举措来说,OS始终是金标啊。

2023-05-19 09:05

额。。。。。。

都是双终点(mPFS+OS)啊,和黄那个也是。