Emerging Therapies for High-Risk Non-Muscle Invasive Bladder Cancer
The discussion opens with an overview of the evolving management of high-risk non–muscle invasive bladder cancer (NMIBC) and introduces the session’s goals of reviewing the treatment landscape, recent clinical data, and best practices for integrating new therapies. The expert faculty emphasize that accurate risk stratification is foundational to guiding treatment decisions. They review major guidelines, including those from the AUA/SUO, EAU, and NCCN, and explain how patients are categorized into low-, intermediate-, and high-risk groups based on tumor grade, size, and pathologic features. The conversation highlights key differences between these frameworks and how they influence clinical decisions in practice. The faculty note that most patients fall into the intermediate- or high-risk categories, with high-risk disease carrying the greatest threat of recurrence and progression. They also discuss the need for multidisciplinary collaboration and early risk assessment to inform appropriate, bladder-sparing therapeutic strategies in NMIBC management.
The expert faculty discuss persistent challenges and unmet needs in managing high-risk non–muscle invasive bladder cancer (NMIBC), emphasizing the impact of Bacillus Calmette–Guérin (BCG) shortages on patient care. They note that many cases of BCG-unresponsive disease stem from inadequate transurethral resection or incomplete adherence to BCG induction and maintenance protocols. The conversation highlights that, despite BCG’s proven efficacy, inconsistent delivery and supply constraints limit real-world outcomes. Faculty members describe how institutions are adapting to intermittent shortages by adjusting maintenance schedules, reducing doses, or sharing limited supplies among patients. They also explore the broader implications of supply issues, including barriers to clinical trial enrollment and variability in treatment access across regions. The panel underscores the urgent need to expand BCG production capacity, develop standardized rationing strategies, and investigate alternative or replacement therapies to ensure consistent and effective treatment for patients with high-risk NMIBC.
The expert faculty explore the definitions, management strategies, and evolving treatment approaches for patients with Bacillus Calmette–Guérin (BCG)-naïve and BCG-unresponsive non–muscle invasive bladder cancer (NMIBC).
The expert faculty transition to a discussion on emerging therapies for high-risk, Bacillus Calmette–Guérin (BCG)-naïve non–muscle invasive bladder cancer (NMIBC), focusing on the wave of ongoing phase 3 immunotherapy trials.
The expert faculty discuss the expanding use of immune checkpoint inhibitors in high-risk non–muscle invasive bladder cancer (NMIBC), emphasizing how these agents are reshaping treatment delivery and safety monitoring.
The expert faculty analyze the recently presented ALBAN trial, a phase 3 study evaluating atezolizumab in combination with intravesical BCG versus BCG alone for BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC).
The expert faculty review the pivotal phase 3 CREST trial, which evaluated subcutaneous sasanlimab in combination with Bacillus Calmette–Guérin (BCG) for BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC).
The expert faculty review the phase 3 POTOMAC trial, presented at ESMO, which evaluated durvalumab combined with Bacillus Calmette–Guérin (BCG) in patients with high-risk, BCG-naïve non–muscle invasive bladder cancer (NMIBC).
The expert faculty explore how to select appropriate patients for future use of systemic immunotherapy combined with BCG in high-risk non–muscle invasive bladder cancer (NMIBC), assuming approval of durvalumab or sasanlimab.
The expert faculty discuss the emerging role of circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA) as biomarkers in bladder cancer, exploring their prognostic and potentially predictive implications for non–muscle invasive bladder cancer (NMIBC).
The expert faculty discuss practical and logistical considerations for integrating novel immunotherapies into clinical management of high-risk non–muscle invasive bladder cancer (NMIBC).
The expert faculty emphasize the growing importance of multidisciplinary collaboration and workforce development as NMIBC management evolves to include systemic immunotherapies.
