You know, there’s been a lot of talk in this field about cell-free DNA being either circulating tumor DNA or also urinary tumor DNA. That analysis is ongoing. We presented some of that data. Particularly what we saw is that patients who had undetectable circulating tumor DNA at baseline were more likely to go on to achieve a clinical complete response at restaging...
You know, there’s been a lot of talk in this field about cell-free DNA being either circulating tumor DNA or also urinary tumor DNA. That analysis is ongoing. We presented some of that data. Particularly what we saw is that patients who had undetectable circulating tumor DNA at baseline were more likely to go on to achieve a clinical complete response at restaging. And then the on-treatment ctDNA, which was assessed in cycle two, all patients that achieved a clinical complete response had undetectable circulating tumor DNA. And we actually, our group just recently reported the ctDNA and utDNA from the initial study, GU16257, and it’s very complementary findings. One thing particularly interesting is that in both studies, all patients, whether it’s at cycle 2 in the study or restaging that study, all patients achieving a clinical complete response had undetectable circulating tumor DNA at that time point. So it’s interesting for a number of reasons, but one thing to consider is the fact that if we had included circulating tumor DNA into the clinical restaging assessment, it actually would not have changed at all who we captured as achieving a clinical complete response. So I think that’s sometimes not so well understood because it has very high prognostic value and it has predictive value in certain settings. But the stringent clinical restaging with the methodology that we had discussed actually captured everyone that we would have deemed having achieved it. Where it did potentially have some benefit, and this is what we saw from the initial 16257 study, is that patients who do not achieve a clinical response and then go on to definitive local therapy, detectable versus undetectable ctDNA confers a much higher or lower risk of a metastatic occurrence. So it’s suggestive of potentially either the curative impact of cystectomy in the undetectable patients or the need to escalate therapy in patients that are detectable prior to surgery.
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