Quoting
@VincentRK: Clinical trials:
Easy to criticize. Hard to do.
Five years ago there was absolutely no data on ADC sequencing.
There were two approved ADCs, T-DXd and SG
With different target, linker, pharmacokinetics and slightly different payload structure.
A clear unmet need in the post-T-DXd HER2 setting.
Could the two ADCs work one after the other and help patients with HER2 MBC?
Two ways to attempt answering this question.
The faster, yet imperfect one: retrospective studies. We tried.
We (and others) analyzed data from hundreds of real-world patients across the US.
Presented and published our findings.
academic.oup.com/jnci/articl…
Important questions, though, require quality answers.
We concomitantly designed the trial.
In a way to stop it early, after only 27 patients, if the answer was “not sufficient activity”, to ensure patients safety.
We ran the trial, SATEEN. And can finally provide a prospective answer.
Five years in the making. Huge efforts from research staff from multiple centers and from the sponsor. Generous participation by 27 patients.
To obtain what I believe is a quality answer for an important clinical question.
Not the answer we were hoping for. But one we can build on in the next years.
Clinical trials:
Easy to criticize. Hard to do.