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Sam Chang: Hi, my name is Sam Chang. I'm a urologist in Nashville, Tennessee, and I have the great honor to actually spend some time with Josh Meeks, associate professor at Northwestern. I've known Josh ever since he was a fellow at Memorial Sloan Kettering, and we both survived the fire there. And we'll always be grateful to be a Memorial graduate. But we want to talk a little bit about nadofaragene and its use in the BCG unresponsive population. So, tell me a little bit about your experience or how you see it fitting into the treatment regimen protocol.

Joshua Meeks: I think it's a really critical time for nadofaragene because as the trials are being done by the SUO CTC, and I remember seeing the presentations and standing ovation when the data was presented, and then soon after FDA approval-

Sam Chang: Right.

Joshua Meeks: And-

Sam Chang: That's lots of paper, FDA approval, all these things.

Joshua Meeks: Right.

Sam Chang: Absolutely.

Joshua Meeks: Right. Huge momentum. And it's one of these things where the patients now walk up to us and say, "When can I get this?" And so this is actually the first time that we've had the opportunity to begin to bring this into the clinic. And so we're really excited about that. I mean, I think, again, the data is incredibly strong. And our patients, they're their own advocates most of the time. I mean, we don't have that many really effective tools, right?

Sam Chang: Right.

Joshua Meeks: So many of us use, for example, dual chemotherapy, gemcitabine, docetaxel pretty heavily when patients don't respond to BCG. And then the problem is if that doesn't work, you're kind of looking at Pembrolizumab-

Sam Chang: Right.

Joshua Meeks: ... with a fair bit of toxicity. So to be able to have this in the clinic, to be able to give it to patients, the dosing at every three months, really strong response rates, I can't wait to be able to have that to say, and literally this week I was coordinating a patient from across the country that was looking at the sites that had this in this early access program, this ABLE-41 study.

Sam Chang: Right.

Joshua Meeks: They were looking for what sites they could get it. So now that we can begin to offer that at Northwestern, I'm really excited to have that as an option to be able to provide to patients.

Sam Chang: Right. So we were fortunate at Vanderbilt to be one of the early access sites, and we have been able to deliver it to patients. But just more recently now, the population now has actually opened up.

Joshua Meeks: Yeah.

Sam Chang: There are sites now fully available, ready to go wherever site, you don't need the early access.

Joshua Meeks: Yep.

Sam Chang: And so you were pointing out patients really now have an opportunity that don't fit into clinical trials-

Joshua Meeks: Yep.

Sam Chang: ... that are looking for intravesical components.

Joshua Meeks: Yes.

Sam Chang: And then I think really attractive to many of our patients is the once every three months.

Joshua Meeks: Yeah. I mean, it's life-saving therapy in the sense of if you're not offering that, you're potentially talking about a cystectomy for all its benefits, but also for all of its risks.

Sam Chang: Right.

Joshua Meeks: I mean, no matter what we do, those complication rates are still there. And again, to be able to say, "I have something else we can try," I think that's a great opportunity for folks and not everybody will go for that.

Sam Chang: Sure.

Joshua Meeks: But I think, again, to be able to provide that to folks, I think it really is another possible bullet to go after this cancer-

Sam Chang: Right.

Joshua Meeks: ... and to try for a patient.

Sam Chang: So at Northwestern, how are you logistically getting set up to start giving this?

Joshua Meeks: Yep. So literally just got the email this week that it's now fully available. So I immediately sent that off to our office manager and said, "Okay, what's the process? How do we get this started?"

Sam Chang: Right.

Joshua Meeks: So there's going to be the P&T committee that's going to have to review it from a hospital perspective. There's going to have to be education for our nurses as far as making it up. Then I think there's going to be some physician learning-

Sam Chang: Yes.

Joshua Meeks: ... as far as how we give it, which patients are going to do well with it, what we need to talk about for side effects, and some educational part to it. But it's a new day, right?

Sam Chang: Right.

Joshua Meeks: I mean, there are not many times I can say there's a new therapy that I can provide.

Sam Chang: Right.

Joshua Meeks: So I'm really excited about that.

Sam Chang: That's FDA-approved.

Joshua Meeks: Yep.

Sam Chang: That's shown efficacy. That has a tolerability profile that is actually-

Joshua Meeks: Right.

Sam Chang: ... quite acceptable for these patients that are looking for intravesical options. And so as we started the rollout, what we did was our clinical nurses really got together with our research nurses in terms of what to expect, what to do. And obviously, the pharmacy came into play in terms of safety requirements-

Joshua Meeks: Yep.

Sam Chang: ... what we need to do. But in terms of the actual process of giving the medication, that type of thing, it's really no different from our other intravesical treatments. And patients feel comfortable with that, understanding that. And so obviously-

Joshua Meeks: How does that discussion go with the patient when you have now something to talk about? I mean-

Sam Chang: Well, I can't really discuss a cystectomy at all.

Joshua Meeks: Yeah.

Sam Chang: I mean, I now couch it in that because I have been talking for honestly months to some of these patients. They'll ask, "If this BCG doesn't work, what's next?"

Joshua Meeks: Yep.

Sam Chang: And some of them are on the market and they say, "The next step, you're not going to take out my bladder." I mean, they'll say that preemptively. Others aren't so sure what's going to happen next. And we talk about trials and we talk about-

Joshua Meeks: Yeah.

Sam Chang: ... but as you know, so many patients don't fit into those strict buckets.

Joshua Meeks: Yep. Yep.

Sam Chang: And so I tell folks, look, there is an FDA-approved agent. We give it once every three months, and they're incredibly excited about it. And then for a few months, I couldn't tell them that it's available. I said, "At some point it's going to become available." And now to get to the point where it's open access-

Joshua Meeks: Yep.

Sam Chang: ... I think now we'll be talking with patients about, "Okay, we have this. If this doesn't work, we have this FDA-approved medication that we give a try." In all honesty, this combination, they love the idea of the dosing, but actually some patients are wondering, "Am I getting enough? Do I need more?"

Joshua Meeks: Yeah.

Sam Chang: It's almost to the point of, "Hey, is this enough?" And then we talk a little bit about the dosing over a year-

Joshua Meeks: Yep.

Sam Chang: ... and those things like that. But they're very excited.

Joshua Meeks: How do you stagger it with the cystoscopies?

Sam Chang: So what we have started doing, because on the trial is basically every three months cystoscopy. So what we're planning on doing is we've given our first patients, actually we're taping this in January, we gave our first two patients the medication in December. I'm going to take a look in a few months, three months, and take a look. And with early on in this experience, to me, the tougher question is, in the real world, and I've talked with others about this, there's a real chance that another dose is going to be effective.

Joshua Meeks: Yeah.

Sam Chang: I think that, and I don't know that for sure, and the early data suggested, look, the only people that had a response to three months were the only ones that really had a CR down the line. But I am planning to do, at this point, planning on taking them all to the operating room. I'm going to do a blue light.

Joshua Meeks: Yep.

Sam Chang: I'm going to biopsy areas of previous concern-

Joshua Meeks: Yeah.

Sam Chang: ... anything else, and then see what we've got. And I'm a believer in if multiple biopsies are done and the volume of disease has decreased-

Joshua Meeks: Yes.

Sam Chang: ... if something is going on-

Joshua Meeks: Yeah.

Sam Chang: ... and looking at urine results and that type of thing, so far, the tolerability has been no different from our study patients.

Joshua Meeks: Yeah.

Sam Chang: And we felt quite lucky to be involved in the studies. And so this is an option where looking at the alternatives and understanding that this has actually shown in rigorous studies-

Joshua Meeks: Yeah.

Sam Chang: ... hey, there's a benefit. It's something that actually gives a lot of patients real hope of, "Okay, I've got something that's got a real chance to work." It's not a 100% home run.

Joshua Meeks: No.

Sam Chang: And we know there seems to be a tail-off over time, but still a real option.

Joshua Meeks: Yeah, I agree with, I like the quantitative mapping. I think seeing a sea-change improvement is a big deal. I'm excited to see how many people get out to two years.

Sam Chang: Yeah.

Joshua Meeks: Because I think we know, in general, if you can give people two years disease-free, they're largely clear.

Sam Chang: They're going to be okay.

Joshua Meeks: Yeah.

Sam Chang: They're going to be okay. So no, I look forward, because we've talked about this before, I love bouncing off real-world scenarios with you because I know you're an individual that's really treated a lot of patients, seen them put through trials, put them through other kinds of treatment options, obviously operating on them in terms of cystectomy. But I look forward to seeing what your experience has been and how that goes. And I think all of us will look forward to it as well.

Joshua Meeks: Yep. New day.

Sam Chang: Absolutely. Well, thanks again, Josh.

Joshua Meeks: Thanks, Sam.

Sam Chang: It's always good seeing you.