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
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.