Sarah Psutka: Well, I think one question I often get is what is an early access program? And we've talked about this before, but this is based on the data from BOND-003. We are very excited about the fact that we will likely have another drug. This is the Cretostimogene to add to our armamentarium against BCG-unresponsive CIS with or without papillary disease. This is an increasingly crowded space.
Sam Chang: Yes.
Sarah Psutka: But as we all know, we need more drugs in this space because not all patients have access to the drugs that are currently FDA-approved. And interestingly, we don't have a lot of data at this point about how those drugs perform in real-world settings. The sponsor has developed this design with the objective of allowing a drug that is likely to have regulatory approval within the coming-
Sam Chang: Everyone's hopeful, absolutely. Yes, yes.
Sarah Psutka: Fingers crossed, hopefully we will see this within the near future to get this into the hands of providers who are taking care of patients who can't receive or basically are not willing or able to receive any of the other drugs that are available. What's interesting about it, and I think what's really critical about it and what's different about it is that the eligibility criteria essentially is much more reflective of our bladder cancer patient population than the patient population that could enter any of the phase-three single-arm regulatory trials. So we're not talking about patients who have really pristine and performance statuses, which you and I both know doesn't really reflect our patient population. So these will be people who can't access another clinical trial, can't access the FDA-approved options that we have. And it'll offer us an early window into the real-world efficacy of the drug that in BOND-003 had a 75.5% CR rate and a median duration of response of over two years, 28 months at the last analysis, which I think is really exciting for all of us to see not only a deep initial response, but sustained response. So it's going to be exciting to see how that plays out in this real-world patient population.
Sam Chang: I mean, as you know, there are so, honestly, a smaller proportion of patients clearly that fit the clinical trial criteria of any trial. And from my understanding, you can have patients who have worse performance statuses, multiple comorbidities, giving them a chance to, honestly, many can't undergo cystectomy and giving them something else that is really something that shows some real possible efficacy and long-term efficacy. Definitely. So tell us a little bit about that.
Sarah Psutka: Well, and I think that what we're... So the co-primary endpoints for this extended access program are CR at any time, which is commonly used by the FDA in the regulatory approvals, but also safety. Because obviously, if we are going to be looking at how this drug performs in a real-world patient population, understanding the adverse event profile is going to be really important.
Sam Chang: Especially if the population has more comorbidities or worse performance status, it'd be very, very important to know. And then other, I think you were talking to me before about patient-reported outcomes and quality of life.
Sarah Psutka: Well, that's the other exciting thing is that the company's been really thoughtful about putting in some patient-centric endpoints that I think our patients really want to know. One of the challenges in this, I think it's fair to say it's a really exciting space because it's increasingly crowded, but we have only these single-arm studies with an absolute vacuum of comparative data. So when you're talking to a patient and trying to walk them through the shared decision-making around, "Which agent do I go to next?" We're very limited in terms of any kind of guidance with respect to either sequencing or sort of selection after one agent no longer is working. How do we decide what do we go to next?
Patients often end up asking, "Well, what's life going to be like on this drug?" The company has been really, really thoughtful, I would say, about including more patient-centric endpoints in the study to get that patient-reported outcome data, understand how this is going to affect health-related quality of life and bladder cancer-specific quality of life as you're going through therapy. And that really, at the end of the day, a lot of times can be very important to patients when they're trying to decide, is this worth it for me to try? And I just want to harken back to something you already said, which is, you think about it, a lot of the times these patients, not only do they not have any other bladder-sparing options, but cystectomy's off the table for many of these patients. These are the patients that actually this trial potentially could really benefit are those patients who can't go to cystectomy because the medical risks are prohibitive. And so here's an option for another bladder-sparing treatment that has really strong efficacy data behind it and safety.
Sam Chang: With a long duration response and safety, et cetera.
Sarah Psutka: That may actually buy them some more time.
Sam Chang: And I'm assuming enrollment, is enrollment still open for centers? Can they go to CG Oncology and say, "Hey, we're interested in this."?
Sarah Psutka: Absolutely. And thankfully a lot of the centers that have been activating are now open. So for example, the University of Washington, we just opened, I think last week, so we are getting our first couple of patients on.
Sam Chang: Oh, fantastic.
Sarah Psutka: And we have a list of people who have been waiting to jump on. And so we will be recruiting and consenting them over the next two weeks, which we're really excited about.
Sam Chang: Well, I think the data from this will be, as you stated, to have actually this widely variable cohort is really, just as you said, it's real-world and you really are extending the access to patients for this.
Sarah Psutka: I was thinking a little bit, I don't know if you had a chance, our breakout session that we had yesterday. The ASCO program committee has done such a great job at this meeting, but they offered us an opportunity to run a session on frailty and patient-centric health points and sort of geriatric oncology. And a couple of my co-panelists spoke specifically about essentially geriatric oncology concerns around the pharmacokinetics of drug absorption and drug tolerance in older patient populations. One of the key take-home messages was how underrepresented our older and frail patients are in the clinical trials that lead to regulatory approval of all these new agents. We don't know how any of these drugs actually perform in the patients that we really treat.
Sam Chang: And that we see every day.
Sarah Psutka: And so I really am excited about the fact that this extended access program has been put out there as an opportunity to gain real-world data in a representative patient population. I think it's potentially really valuable data. And yes, an extensive access program has a limited timeline in terms of how long it's open. It's open until we have regulatory approval, but we can gather a lot of really important data in that time.
Sam Chang: No, that's fantastic.
Sarah Psutka: So I'm excited for that.
Sam Chang: That's fantastic. Sarah, thank you so much for your leadership in this and all the many different endeavors that you engage yourself in and help lead. So thanks so much.
Sarah Psutka: Thanks for having me.