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Zachary Klaassen: Hello. My name is Zach Klaassen. I'm a Urologic Oncologist at the Georgia Cancer Center and a guest of Georgia. And I'm delighted to be joined on UroToday by Dr. Amanda Myers, who is a Urologic Oncology fellow at MD Anderson Cancer Center. Amanda, thanks so much for joining us today.

Amanda Myers: Glad to be here.

Zachary Klaassen: So we're going to be talking today about data you presented at the AOA South Central meeting, looking at real-world treatments following BCG induction in patients with NMIBC. And this is a contemporary US claims analysis. So why don't you walk our listeners through your data, please, Amanda.

Amanda Myers: Great. So this study was funded by Ferring Pharmaceuticals. Essentially, we know that intravesical BCG is the standard of care for high-risk non-muscle invasive bladder cancer. However, we know that a substantial number of patients will experience treatment failure with BCG. Treatments after BCG can include both radical cystectomy and bladder preservation therapy. However, the contemporary real-world treatment patterns in patients after BCG are truly unknown.

So our objective was to examine contemporary real-world data regarding the utilization of BCG and to examine treatment patterns for patients after induction BCG. The primary data source for this analysis was the Komodo Health claims database, which is de-identified longitudinal claims data from 320 million Medicare Advantage, Medicaid, and commercially insured patients between January 2018 and March of 2023.

We applied an algorithm to essentially proxy high-grade non-muscle invasive bladder cancer in patients who were continuously enrolled at least a year before and a year after BCG. Of the patients we identified who had received BCG, actually, only 2/3 had received an adequate induction, which we defined as at least five doses. In total, 3,206 patients were analyzed who received adequate BCG induction, including 922 with CIS.

What we found after adequate BCG induction, over 1/3 of patients had no claims for additional treatments. Twelve percent of patients used other therapy following BCG, and half of patients continued with BCG alone, and only a quarter of these (25%) received at least two doses of maintenance BCG. When we look at the treatment with other therapy, there was significant heterogeneity in treatment following BCG.

We see that radical cystectomy only made up about 20% of the patients, and the vast majority received bladder-sparing therapy, which ranged from single-agent intravesical therapy with mitomycin C and gemcitabine being most frequently used, and less commonly combination therapies and systemic therapies being offered. When we focused in specifically on the patients with CIS, we observed similar treatment patterns.

A 1/3 of patients received no additional treatment after their induction BCG, 15% proceeded with other treatments, and about 50% continued with BCG alone. And again, we saw similar rates for treatment with other therapies, with a bit higher treatment with BCG plus interferon alpha in the CIS group. In conclusion, what we can say from this data is approximately 2/3 of patients treated with BCG received adequate induction and only 1/4 of patients actually received adequate maintenance BCG.

We found there was significant treatment heterogeneity following adequate induction BCG. And additionally, we found radical cystectomy rates were very, very low, only about 2 to 3% among these patients. In other terms, for every four patients treated with bladder-preserving therapies, there was one patient who underwent a radical cystectomy.

The next steps are really to conduct follow-up studies to inform how these treatment patterns change when we introduce novel bladder-preserving therapies into practice and how patient outcomes will be affected by these current treatment patterns. Thank you.

Zachary Klaassen: So Amanda, a great presentation and congratulations on excellent data. There's certainly a lot to unpack from your presentation. But one of the key things I noticed, you mentioned the quarter maintenance after induction therapy. Is this a result of just difficulty in the claims database capturing this, or do you think there's a true underutilization of maintenance therapy? What are your thoughts on that number?

Amanda Myers: So I think that the discontinuation rates in general for BCG, we know they're higher than we would expect from adverse events alone. So I think this is real information that a lot of patients are not receiving maintenance BCG. And it's not surprising. The reason that patients are not receiving maintenance BCG, to me, is multifactorial. They may not have been offered it just due to the shortage.

Our study was from 2018 to 2023. So many patients may not have received it during the pandemic. And I also think patients may not be educated on the treatment course from the outset, and the treatment burden and time toxicity of receiving these intravesical treatments builds up over time and does lead to discontinuation at alarming rates.

Zachary Klaassen: Yeah. I think you nailed it. Once you get to those maintenance doses, it's hard for people to keep going back and they get fatigued from the travel, from the time, everything, right?

Amanda Myers: For sure. And we see that every day in our practice. And we rely on caregivers who can't get out of work to come. And not many patients make it through the full three years.

Zachary Klaassen: It's hard. There's a lot of data from your subsequent treatments. Is there anything that jumped out at you as surprising? Certainly it was all over the map with a lot of options. Any key take-home points from the subsequent therapies?

Amanda Myers: So a lot of patients are actually getting bladder-preserving therapy. We're seeing about a 4:1 rate with the cystectomy. And we're seeing a lot of single-agent intravesical chemotherapy being used in these patients. And I think that's probably reflective of the general practices in the United States.

Zachary Klaassen: Yeah. And I think you're right, too. And there really is no set guideline as to what the next step is at this point, too, right?

Amanda Myers: Yes. That is true. And this is not a particular timing after BCG. This is just a very general, broad take of what's actually happening in the real world.

Zachary Klaassen: Lastly, the cystectomy rate of 2 to 3%. You and I talked at the meeting about this, and there could be a lot of things going on with that low rate of cystectomy. What are your thoughts on why that rate is so low?

Amanda Myers: So there's a couple of reasons. I truly do think that the rate of actually receiving additional therapy after BCG is very low. And that's in alignment with prior studies. I think we don't find that many patients that actually receive subsequent therapy. And then as we see a trend towards more bladder preservation and patients desiring more bladder preservation, having more knowledge about that, the cystectomy rates are going down.

Finally, with this data set in particular, I'm not sure how much of the high-volume tertiary and academic centers are actually captured by this dataset. It may reflect just the practice setting that we identified. The centers included are de-identified just for privacy concerns, so I can't really comment on what we actually captured.

Zachary Klaassen: Yeah. A lot of them are going to be probably private practice, which may be less inclined to do or to send to tertiary centers for cystectomy that may not get captured, right?

Amanda Myers: Exactly.

Zachary Klaassen: Great discussion and awesome data. Our listeners will certainly enjoy hearing our conversation, I'm sure. But maybe a couple take-home messages for closing out.

Amanda Myers: I think really the big takeaway from this study is that maintenance BCG is underutilized, and we really need to educate our patients on the importance of maintenance BCG and the schedule from the outset of treatment before they start on their BCG treatment journey.

Zachary Klaassen: Right. I think that's key—education and expectations, right?

Amanda Myers: Yeah.

Zachary Klaassen: Awesome job. Well, Amanda, thanks so much for joining us and for sharing your expertise on UroToday.

Amanda Myers: Thanks, Zach.