发布于: Android转发:2回复:10喜欢:0
但是我想起了$和黄医药(00013)$ 了。。。OS未达到,mPFS达到,仍然可以申报二线GC适应症。。。国内的申报标准有些迷。。。
引用:
2023-05-19 07:20
康宁杰瑞制药-B 公告及通告 - [内幕消息] 内幕消息公告 - 有关用於治疗晚期鳞状NSCLC的KN046之III期临床试验的最新进展 网页链接

全部讨论

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.

2023-05-19 09:38

其实我觉得能达到PFS也行,虽然病人并没有活的更长,但起码少受了些罪