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Sam Chang: Hi, I'm Sam Chang. I'm a urologic oncologist at Vanderbilt University Medical Center, and we have really an honor and privilege to have Doctor Trinity Bivalacqua here from the University of Pennsylvania. Really one of the leaders in urologic oncology. And we're going to focus actually on bladder cancer. And we're going to focus on clinical trials as they're developed. And Trinity has actually been an executive board member for the SUO for a period of time and has really helped that organization, has been really active in the SUO CTC trial organization as well.

And so the SUO CTC is really focused on different disease states. Kidney cancer, prostate cancer, bladder cancer, but recently has-- actually, endorses, is going to help enroll in one of the CORE-008 trial arms. So I wanted you, while we had the opportunity to have an expert like you, give us an idea of CORE-008, the SUO CTC, its involvement in what we're looking in terms of the exact study trial.

Trinity Bivalacqua: Yeah, absolutely. Thanks, Sam. So CORE-008 is a multi-cohort, multi-center site-- study, excuse me. Looking at patients with high risk non-muscle invasive bladder cancer. So currently, we have three cohorts. Cohort A is looking predominantly at BCG naive. Cohort CX is looking at patients that have BCG unresponsive as well as BCG exposed. But cohort B is actually looking at BCG exposed patients.

So as you know, this is sort of a newer definition of patients that have high risk disease, high grade disease, that have had a disease free interval for 12 months, where they are disease free. No recurrences, they've received adequate BCG, but unfortunately, then develop a new recurrent high grade tumor. It could be CIS, it could be T1. And we're now looking at new agents in this disease space. It's important that we have the opportunity to see if things like these newer agents like cretostimogene are effective there.

Thankfully, the SUO CTC has been able to endorse and actually allow us to use the SUO CTC mechanism.

Sam Chang: Mechanism. Absolutely.

Trinity Bivalacqua: Yeah, to be able to have investigators from around the country to enroll into this trial. I mean, I can't tell you how helpful it is to have an organization like the SUO that is supportive of bladder cancer in general.

Sam Chang: Sure.

Trinity Bivalacqua: We've actually seen an explosion of trials in the bladder cancer space, and they're all being led by the SUO CTC members.

Sam Chang: And to be able to help integrate and have for different patient populations options in clinical trials. And so I know one of the cohorts is this BCG exposed, which is a patient population that we see many times, that have different levels of BCG exposure, time periods, dosages, et cetera. But really, a group of patients that we don't really know what the next best step is.

Trinity Bivalacqua: Right.

Sam Chang: So tell me, where are we in cohort B in terms of timing, et cetera?

Trinity Bivalacqua: Yeah, so currently, cohort B has just been activated. We're actually able to enroll patients into the cohort B, which is BCG exposed, high risk, non-muscle invasive bladder cancer. They get a six week induction course of cretostimogene. They then have a reevaluation at the three month mark. If there is disease, persistence, high grade disease without progression, then they have the ability to get a second re-induction course of cretostimogene. And then hopefully, they are disease free and then go on maintenance therapy, just like BCG maintenance, like the SWOG protocol.

Currently, we're actually enrolling and able to have this patient population there. And--

Sam Chang: So sites are being looked for by the SUO?

Trinity Bivalacqua: Sites are being looked for. Hopefully, in the process of activating and be able to look at this. And I think you made the point earlier that we don't know how to treat these patients, right? Do we give them more BCG or they, the patients that will respond? I mean, we know that there's patients that respond to that, but there's so many that don't.

Sam Chang: Right.

Trinity Bivalacqua: So we're investigating the role of this oncolytic immunotherapy in this BCG exposed population.

Sam Chang: Right. Because we really, at this point, we don't know, are they going to respond. Just as you said, there's definitely a proportion of patients that will respond, but there's definitely a significant proportion that don't respond. And we're giving them therapy that really isn't that effective based upon what we've done in the past. So to gain information in this patient population, I think is very, very important. So as sites open up, and as we enroll patients, give me an idea of the scope of the trial.

Trinity Bivalacqua: Yeah, so what we're looking for is investigators that have a population of patients that have non-muscle invasive bladder cancer. In this case, BCG high risk, BCG exposed. We identify a site an investigator then go through the SUO CTC, they get activated, and then our goal here is to have over 100 patients in this trial to be able to determine if there's activity there.

Sam Chang: I understand.

Trinity Bivalacqua: And the reason why, I know we keep on talking about the SUO CTC, but in reality, they're just amazing investigators that are there, that are committed to advancing the field of urologic oncology. And we're able to enroll so many patients, so quickly. I mean, if you think about Adstiladrin, which went through the SUO CTC with the phase II and phase III, we enrolled all those patients. 130 patients in less than two years.

I mean, think about that. It's really unbelievable. And that's why companies like CG Oncology are using the SUO CTC because they know that these are established investigators who are committed to advancing the field.

Sam Chang: Well, promise me that as we get results, as we understand better in terms of early data and long-term data with this population, to share all this information with your folks here at UroToday and look forward to that future presentation, because we know options, at least, really provide our patients a significant change compared to the days in the past where cystectomy was really the treatment option that was recommended, or attempts by us to come up with something that we really didn't have anything that evidentially supported what we really thought was helpful or not.

Trinity Bivalacqua: Absolutely.

Sam Chang: So, look forward to seeing you in the future, Trinity, and thanks so much.

Trinity Bivalacqua: Thanks, Sam. Appreciate it.