Dr. Aaron Berger Discusses A New Wave Of Bladder Cancer Therapies
At the American Urological Association (AUA) 2025 Annual Meeting, an expert panel convened to discuss the evolving treatment and diagnostic landscape of non-muscle invasive bladder cancer (NMIBC). Moderated by Sia Daneshmand, MD, University of Southern California, the roundtable consisted of Mark D. Tyson, MD, Mayo Clinic; Aaron Berger, MD, Associated Urological Specialists; and Vignesh T. Packiam, MD, Rutgers Cancer Institute.
In the first segment of the discussion, the panel discusses a wave of bladder cancer therapies—including cretostimogene, gem/doce, and AI-driven biomarkers—highlighting the excitement around new data, treatment sequencing, and the potential of combination strategies to improve bladder preservation.
In addition to treating prostate cancer, Associated Urological Specialists offers many advanced bladder cancer treatments and multiple clinical trials.
Here is the full transcript from that discussion, as published at Roundtable NMIBC.
Dr. Daneshmand: Hi everyone, this is Sia Daneshmand. I am Director of Urologic Oncology at USC in Los Angeles. With me today are three esteemed colleagues. We are here with GU Oncology Now, and I will let the panel introduce themselves.
Dr. Tyson: Mark Tyson. I am a urologist at Mayo Clinic in Arizona.
Dr. Berger: Aaron Berger. I am a urologist at Associated Urological Specialists in the suburban Chicagoland area.
Dr. Packiam: Vig Packiam. I am a urologist at Rutgers Cancer Institute.
Dr. Daneshmand: It has been an exciting AUA 2025, has it not? We have seen new data and some important updates. Dr. Tyson, what are you most excited about?
Dr. Tyson: Well, I am biased.
Dr. Daneshmand: You presented some of the data!
Dr. Tyson: Yes, I presented the BOND data, so I am really excited about that. But honestly, that whole plenary session was very exciting. BOND was the cretostimogene phase III trial, showing excellent durability and tolerability. The top-line numbers were 46% at one year and 33.7% at two years. There were not a lot of side effects: no grade 3 events. Very exciting data.
I think that is going to be one of many strong options for us going forward. The SunRISe-1 trial also updated their data for both CIS and papillary cohorts, with very similar top-line efficacy numbers. That was also great to see. The CREST trial read out, and Dr. John Gore presented the CISTO trial. It was truly a “comedy of riches” at this AUA.
Dr. Daneshmand: Really amazing. From your perspective, Dr. Berger, what stands out from a community standpoint as these drugs become available? What are you most excited about?
Dr. Berger: As Dr. Tyson mentioned, I think the variety of options now is incredibly exciting. This treatment space has been relatively stagnant for a long time, and now we have a plethora of new options. That is great for our patients and also energizing for us as clinicians.
In terms of which therapy might emerge as the standard—whether it will be combination therapy, sequencing, or a single standout agent—I doubt there will be one clear winner. As with many things, people will have preferences based on what they are familiar with, which trials they are involved in, ease of use, or route of administration.
The key takeaway is that we now have multiple options and different mechanisms of action. For our patients who want to preserve their bladders, especially those at high risk, we now have choices. If one option does not work, we can move on to another. As time goes on, figuring out how to best sequence these treatments and identify optimal starting points will be a major focus at future AUAs.
Sia Daneshmand:
Exactly. You mentioned sequencing, and I am going to come right back to you, Vig, with the toughest question: How do we sequence these treatments? You had some great presentations at this year’s AUA.
Dr. Packiam: Yes, I think there are a few different paradigms we can consider. One approach is rational sequencing, where we alternate between immunologic-based therapies and chemotherapy-based agents, which are currently the two predominant classes emerging in this space.
Another approach is biomarker-based sequencing. We are already using some new biomarkers in the treatment-naïve setting. As more real-world data comes in from ongoing trials, we should also gain biomarkers relevant for treatment-refractory patients.
Dr. Daneshmand: Tell us about one of those biomarkers.
Dr. Packiam: We just published this two days ago. It is an artificial intelligence-based biomarker that analyzes the TURBT slide at 40x magnification. We found that it can risk-stratify patients who received either BCG or gemcitabine/docetaxel, helping us make more rational treatment choices.
Dr. Daneshmand: Really exciting work, especially as we start to incorporate AI into our decision-making algorithms. What are your thoughts on combination therapy? Do you see potential in combining immunologic and chemotherapeutic agents in the future?
Dr. Packiam: Absolutely. The most established combination therapy so far is sequential intravesical gemcitabine and docetaxel, or gem/doce. Based on the success of that regimen, others are now exploring different combinations, including trials that continue to evaluate gem/doce.
Dr. Daneshmand: Let us come back to Dr. Tyson, since you played an instrumental role in designing one of the upcoming trials for CG Oncology. This is a combination of immunologic therapy with chemotherapy. Can you tell us more about it?
Dr. Tyson: Yes. The CORE-A CX study—or Cohort CX—is looking at combining gemcitabine with cretostimogene. Cretostimogene is an immunotherapy that selectively replicates in tumor cells with RB pathway deficiency. It also expresses GM-CSF, which supports an immune response. The goal is to induce long-term, immune-mediated, disease-free survival.
When combined with gemcitabine—which induces apoptosis in tumor cells and floods the tumor microenvironment with neoantigens—you theoretically amplify the immune response. The GM-CSF enhances antigen presentation, and now there are more neoantigens for the immune system to act on.
Dr. Daneshmand: That is the theory.
Dr. Tyson: Yes, that is the idea. The trial is evaluating a few different regimens. One is based on what Dr. Packiam helped develop with gem/doce: same-day administration. Another approach involves alternating treatments, such as cretostimogene, gemcitabine, cretostimogene, and so on. Personally, I prefer the latter sequence, as I think patients will tolerate it better, and it might help mitigate some of gemcitabine’s side effects.
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Associated Urological Specialists (AUS) is a unified group of Urologists and related specialists committed to providing comprehensive urological care to patients and their families around southwest Chicago and northwest Indiana. AUS has placed a tremendous emphasis on bringing together a highly dedicated and skilled set of Board-Certified professionals, equipped with the latest state of the art tools and techniques, to deliver a full range of urological care.