How do you ensure that those adverse events are caught early, particularly given the specific comorbidities of this patient population?

Yeah, I mean, I think bladder cancer is a very challenging cancer for a number of reasons.

One is that it tends to affect patients in their 60s, 70s, even 80s.

The median onset is in the mid 60s.

And so, you know, folks who are in their 60s or more mature, they may have more comorbidities, more medical problems.

And we have to be really sensitive to that.

Unfortunately, bladder cancer is very tightly correlated with exposures to toxins in our environment.

autoimmune side effect.

So, Terry, let's talk about what we know.

Sure, so we're learning a lot both in the non-metastatic space for both NMIBC as well as muscle invasive disease.

And so we'll talk about how CT DNA is fitting into this.

These are my disclosures.

So first I'm gonna talk about non-muscle invasive disease, why we're giving PD-1 plus BCG.

We're gonna talk about three randomized phase three trials, CRESS, Potomac and Albin, which were just reported this year.

And then we'll talk about use of pembrolizumab as monotherapy in this group.

Anyhow, let's keep going now with BCG resistance in terms of the trials out there.

So, Terry, let's talk about what we know.

Sure.

So we're learning a lot both in the non-metastatic space for both NMIBC as well as muscle invasive disease.

And so we'll talk about how CT DNA is fitting into this.

These are my disclosures.

So first I'm going to talk about non-muscle invasive disease, why we're giving PD-1 plus BCG.

We're going to talk about three randomized phase three trials, CRESS, Potomac, and Albin, which were just reported this year.

Anyhow, let's keep going now with BCG resistance in terms of the trials out there.

So can you kind of go into this, Terry? Sure.

Sure.

So Invigor 011 is a follow-up to Invigor 010.

That was a study that looked at adjuvant atezolizumab for high-risk bladder cancer, so basically muscle-invasive bladder cancer.

Invigor 010 was negative in all comers, but a subset analysis showed that patients who were self-redenate positive after surgery benefited from getting atezolizumab.

You can think of it as giving drugs to patients who were destined to relapse.

And so the investigators put together this study in Vigor 011, which was a prospective study that assigned patients therapy based on whether or not they were cell-free DNA positive after surgery.

Terry, first of all, what do we see with the SADAMAB, and what do we know about its efficacy and tolerability?