Bintrafusp alfa update

做了一次期中分析，但不会告诉你，研究继续，入组停止，还是300人

Bintrafusp alfa (TGF beta trap/ anti-PDL1)

· Merck KGaA announced on 20 October 2020 that an interim analysis including review by an independent data monitoring committee (IDMC) had previously taken place for the INTR@PID Lung 037 study of bintrafusp alfa vs pembrolizumab. The results of this analysis will not be made public nor will data be published. The study will continue as planned and recruitment has closed at approximately 300 study participants. Having passed futility, the study continues with event-driven PFS and OS analyses.

CT上方案

https://clinicaltrials.gov/ct2/show/NCT03631706

虽然3月份把300人扩大到584人，但现在状态是not recruiting

附  相比最早方案的修改

https://clinicaltrials.gov/ct2/history/NCT03631706?A=1&B=24&C=Side-by-Side#StudyPageTop

其实在3月份Ph2变为适应性设计的Ph3，时间也延期

样本量随之扩容，主要终点中PFS和BOR变为PFS和OS

次要终点

其他略

其他

之前ESMO前菜提到：bintrafusp alfa 的2LNSCLC的3年随访

后线治疗只看金标准OS，对我来说，下面几个并没有差别

400人肯定比40人的结果更让人信服，所以M7824明年悬