Navigating the BCG Shortage: Gem/Doce and Clinical Trials for NMIBC

Roger Li, MD, of Moffitt Cancer Center, moderates an expert panel consisting of Vitaly Margulis, MD, of UT Southwestern Medical Center; Kyle Rose, MD, Ochsner Health; and Paul Crispen, MD, of the University of Florida, in a discussion on the challenges posed by the ongoing BCG shortage, innovative strategies like gem/doce, and the role of clinical trials in advancing treatment options for high-risk non-muscle invasive bladder cancer (NMIBC). Recorded live at SUO 2024, part one of this roundtable highlights current practices, emerging therapies, and the future landscape of NMIBC care.

Watch the second part of this roundtable: Treatment Options for BCG-Unresponsive NMIBC: Balancing Efficacy, Logistics, and Patient Preferences

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Dr. Li:
Hi, good morning. My name is Roger Li from the Moffitt Cancer Center. Here we are at SUO 2024, and I have three distinguished experts with me here. So we’ll just go around and first have each of you introduce yourselves, and then we can have a conversation about bladder cancer. So, Dr. Margulis?

Dr. Margulis:
Vitaly Margulis. I’m local at UT Southwestern in Dallas. I’m a urologic oncologist, and about half my practice is bladder cancer.

Dr. Rose:
I’m Kyle Rose. I’m a urological oncologist from Ochsner, also specializing in bladder cancer.

Dr. Crispen:
Paul Crispen. I’m a Professor of Urology at the University of Florida, and I also serve as the Associate Director of Clinical Research for the UF Health Cancer Center.

Dr. Li:
Great. It’s great to have all of you here with us today. So we’re talking about one of the topics that’s near and dear to my heart and I’m sure to yours as well, high-risk non-muscle invasive bladder cancer. So just to start things off, with the BCG shortage and such, Vitaly, are you still kind of going to BCG for all of you high-risk NMIBC patients?

Dr. Margulis:
So generally, in a large academic practice, we’ve been relatively sheltered from the BCG shortage, but we made adjustments. So for example, we have, in certain patient populations, limited maintenance only to high-risk patients, not intermediate-risk patients. We have now administered routinely one-third of the dose. But we see patients from the community who are affected by shortage, and they’re given treatments. They’re not BCG perhaps, a little bit off the standard of care.

Dr. Li:
Yeah. And what about you guys?

Dr. Rose:
Same. I think it’s a month-to-month issue that we frequently check in when we have a patient with a new finding of high-risk non-muscle invasive bladder cancer. Fortunately, we’ve been able to give the induction courses, but we’ve also gone to 5/6 or 2/3. So it’s really the maintenance for those high-risk patients that I think gets sacrificed first.

Dr. Crispen:
We’ve used similar strategies as well. Also, a big part of our practice is offering clinical trials. They’ve actually helped us provide BCG to patients who aren’t eligible for those trials, while still giving patients other alternatives along the way.

Dr. Li:
Yeah. And that’s a great point that you raised. One of the more important trials that we’re running at our center is the BRIDGE Trial. So what are your thoughts on gem/doce maybe becoming another option in the frontline setting?

Dr. Crispen:
We’ll see. I think it’s an outstanding trial run by Max Kates. It’s occurring very well. It still has several years ahead of it. I think that’s a great example. Another great example that we’ll probably have results out much sooner is SWOG 1602.

Dr. Li:
Absolutely.

Dr. Crispen:
TICE BCG versus Tokyo-172 with the arm of the vaccine before BCG as well. And so that may actually help us with the BCG shortage, and introducing a new strain to the U.S. But I don’t think those results are going to be out for another year or so.

Dr. Rose:
I’ll just echo what he said. With the BCG shortage, it really drove us to select clinical trials in that space to help replace the need for BCG, or fill that deficit of the BCG shortage. So we always have something to offer patients, whether it’s the standard of care or inside the arms of a clinical trial.

Dr. Margulis:
Yeah, I would say, as crazy as it sounds, BCG’s been the front-liner standard of care for 50, 60 years now. We really don’t fully understand how it works. We don’t fully understand how to properly select patients, and we really haven’t, until recently I think, moved the needle to improvement upon BCG results.

Dr. Li:
So projecting a little bit, let’s say if gem/doce does become another option in the front-line setting, how does that affect your choices of choosing drugs? Is it going to be BCG if a patient were to have a high-grade recurrence after gem/doce, or is it going to be one of these newer agents that we will discuss in a little bit?

Dr. Margulis:
A million-dollar question. I think this may be dictated by the payers to some degree. I think there’s several trials of gem/doce in front-line, right, first-line space versus BCG refractory. And we have to look at the data. And I think that’ll be data driven. If there’s clear-cut superiority to gem/doce over BCG, I think the question may be answered very quickly.

Dr. Li:
I guess, have you guys had any experience with gem/doce in the front-line setting? Either on a trial or just because of the BCG shortage, you’re putting some of these patients first on gem/doce instead of BCG?

Dr. Rose:
Absolutely, yeah. We’ve had some patients who were BCG-eligible. We did not have it available. They did not meet BCG unresponsive FDA criteria. We couldn’t put them on a trial. We didn’t have an agent available at the time and we’ll put them on gem/doce.

Dr. Crispen:
Yeah, I think to your question that you had asked Vitaly before, it’s the selection of gem/doce vs BCG or  other agents that is really going to be down to toxicity; which agents are patients going to do better on? But also, I think that Vitaly brought up an outstanding point of selection. Because right now we’re just picking one. We don’t really have biomarkers or other information that is necessarily going to say what treatment they’re going to do best on in terms of recurrence or otherwise.