惨胜？KEYNOTE-355达到PFS主要终点

今天是个令人悲伤的日子，因为108年前的今天：

老佛爷，大清亡了～～

这次达到终点的是CPS≥10的PFS，不知道OS里几个达到终点

In Pivotal Phase 3 KEYNOTE-355 Study, KEYTRUDA Plus Chemotherapy Significantly Improved PFS Compared to Chemotherapy Alone in Patients with mTNBC Whose Tumors Expressed PD-L1 (CPS ≥10)

Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS).

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

Data to be Presented at an Upcoming Medical Congress and Discussed with Regulatory Authorities

还是比预计的晚了俩月

首先看KEYNOTE-355设计，对比Pembrolizumab+化疗（白紫 or 紫杉醇 or GP）对比单独化疗一线治疗mTNBC

入组标准：先前未接受化疗并不可根治、局部复发的不可手术的乳腺癌或先前未接受过化疗的转移性乳腺癌；组织学上确诊为TNBC；

排除标准

试验设计：研究分两部分，第一部分评估Pembrolizumab联合前文提及的三种化疗方案的安全性；第二部分评估Pembrolizumab联合化疗对比安慰剂联合化疗的安全性和疗效

主要假设：1)相比安慰剂+化疗，Pembrolizumab联合化疗可以显著延长所有受试者/PD-L1 CPS≥1/PD-L1 CPS≥10的受试者的PFS；2)相比安慰剂+化疗，Pembrolizumab联合化疗可以显著延长所有受试者/PD-L1 CPS≥1/PD-L1 CPS≥10的受试者的OS

主要终点：3个PFS，3个OS，好端端的IMpassion 130愣是做成了KEYNOTE-181，关键看几个OS到预设了，就怕一手好牌被一把骚操作给毁了

次要终点

之前8过一篇《TNBC的免疫治疗的一些回顾》

anti-PD-1/-L1治疗TNBC的三期临床汇总