NMIBC expert discussion emphasizes multidisciplinary collaboration

Chad A. Reichard, MD

On May 22, 2025, Urology Times^® hosted a Clinical Forum program in Carmel, Indiana. At the event, experts convened to explore the evolving treatment landscape for non–muscle invasive bladder cancer (NMIBC), with a particular emphasis on emerging immunotherapies and the need for multidisciplinary collaboration. Highlighting key clinical trials like CREST (NCT04165317) and POTOMAC (NCT03528694), the discussion focused on strategies to overcome limitations of traditional BCG therapy and improve outcomes for high-risk and BCG-unresponsive patients. The event was moderated by Chad A. Reichard, MD, a urologist with Urology of Indiana. What follows is a summary of this discussion.

This summary was generated by artificial intelligence and edited by humans for clarity.

This Clinical Forum event provided a comprehensive overview of the current landscape in treating NMIBC, with a particular focus on emerging therapies, clinical trial data, and the collaborative approach needed between urologists and medical oncologists. The conversation underscored the complexity of NMIBC management and highlighted the evolving strategies aimed at improving patient outcomes, especially in cases unresponsive to traditional therapies like BCG.

A significant portion of the dialogue emphasized the challenges faced in managing NMIBC. Urologists described the necessity for a multidisciplinary effort, often requiring collaboration with oncologists, especially when considering novel immunotherapeutic options. The discussion notes that historically, urologists have relied heavily on BCG therapy as the standard treatment for high-risk NMIBC. However, the limitations of BCG, including shortages and instances of unresponsiveness, have prompted increased interest in alternative treatments, particularly immunotherapy agents like PD-1 and PD-L1 inhibitors.

The conversation elaborated on clinical trials investigating the efficacy of immune checkpoint inhibitors both as monotherapy and in combination with BCG. Notably, the CREST trial and the POTOMAC trial were highlighted for their contributions to the understanding of immunotherapy's role. The CREST trial is especially significant, demonstrating a 32% risk reduction in disease-related events when sasanlimab, an investigational PD-1 inhibitor, is combined with BCG in patients with BCG-naive NMIBC. The trial's results suggest that integrating immunotherapy with traditional BCG regimens could enhance disease control and potentially address BCG shortages by reducing reliance on extensive BCG induction courses. Similarly, the POTOMAC trial was mentioned as a pivotal study showing improved disease-free survival with the addition of immunotherapy agents to BCG. The hope is that these studies will translate into practice, offering new options for managing both initial and recurrent NMIBC.

The discussion acknowledged the challenges of incorporating immunotherapy into routine practice, especially in community settings. It emphasized the importance of understanding patient selection, contraindications such as autoimmune disease, and the logistics of administering these agents safely. Autoimmune conditions are considered the most common contraindication to checkpoint inhibitor therapy, but many patients with autoimmune diseases can still be treated with careful management. The role of clinical trials in guiding treatment decisions was a recurring theme, with clinicians recognizing that evidence from ongoing studies like CREST and POTOMAC is vital for establishing the efficacy and safety of these approaches in real-world settings.

The conversation also addressed logistical considerations, including the necessity of coordinating treatment between urology and medical oncology. Many smaller urology practices prefer to refer patients to oncologists for immunotherapy administration, especially given the complexities of managing potential immune-related adverse events like pneumonitis and colitis. This division of responsibilities highlights the importance of multidisciplinary collaboration and communication, ensuring that patients receive comprehensive care that balances efficacy with safety. The participants stressed that such collaboration is essential for integrating novel therapies into existing treatment paradigms without creating excessive friction or logistical barriers.

Another key aspect discussed involved the application of immunotherapy in BCG-unresponsive or BCG-intolerant patients. Guidelines for defining BCG-unresponsive disease were referenced, noting the importance of classifying patients properly to determine suitable treatment pathways. The evolving landscape of clinical trials provides promising results for patients in this category, with multiple studies examining the combination of immunotherapeutic agents with BCG or alternative intravesical therapies. The CREST trial, for instance, demonstrated that BCG combined with the PD-1 inhibitor sasanlimab led to a substantial reduction in disease-related events, which is promising for shifting standard treatment practices.

The discussion also considers the future direction of research and practice. Emphasis was placed on the importance of ongoing clinical trials that evaluate the potential of immunotherapy agents such as cemiplimab, atezolizumab (Tecentriq), and durvalumab (Imfinzi) in combination with BCG. These studies aim to enhance not only recurrence-free survival but also progression-free and overall survival, which are critical endpoints in the management of NMIBC. The discussion suggested that as data mature, treatment algorithms will likely evolve to incorporate these agents more routinely, especially in patients at high risk of progression or those who have failed BCG therapy.

Furthermore, the participants explored the broader context of integrating immunotherapy into early-stage disease management, paralleling approaches seen in melanoma and kidney cancer. There was consensus that as understanding of tumor mutational burden and immune responsiveness grows, the shift toward earlier intervention with immunotherapy could become mainstream. This shift will depend heavily on continued research and validation of trial outcomes, combined with practical considerations such as health care system capabilities and financial models to support these therapies.

In summary, the Clinical Forum provided a detailed review of the current and emerging landscape of NMIBC treatment. It underscored the importance of clinical trial data, particularly the results from the CREST and POTOMAC trials, in shaping future practices. The conversation outlined the potential of immunotherapy agents, like sasanlimab, to improve patient outcomes, especially when combined with BCG. Although challenges remain in implementing these therapies broadly, especially in community practices, multidisciplinary collaboration and ongoing research are vital to ensure that advances translate into tangible benefits for patients. The overall tone emphasized cautious optimism, with recognition that ongoing trials and real-world data will define how these novel strategies are integrated into standard practice.