Emerging Immunotherapy Trials and Design Nuances in High-Risk 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. They note that multiple checkpoint inhibitors—pembrolizumab, durvalumab, and cetrelimab—as well as the TAR-200 intravesical gemcitabine delivery system, are under investigation in this space. The faculty emphasize that while these trials share a goal of improving outcomes beyond standard BCG therapy, they differ significantly in design elements, including treatment duration, sequencing of BCG with immunotherapy, inclusion and exclusion criteria, and geographic enrollment. Examples include the ALBAN, CREST, POTOMAC, PATAPSCO, and KEYNOTE-676 studies, each with unique timelines and control arms. The discussion underscores that understanding these design nuances is critical for interpreting results and comparing efficacy across studies. The panel concludes that the growing diversity of immunotherapy trials marks a pivotal step toward expanding treatment options for NMIBC.