Evolving treatment paradigms in high-risk NMIBC

Félix Guerrero-Ramos, MD, PhD, FEBU, discusses key findings from the phase 3 POTOMAC trial and other studies of BCG/ICI combinations in high-risk NMIBC.

Bradley McGregor, MD, contextualizes recent data on emerging treatment regimens in high-risk, BCG-naïve NMIBC.

John P. Sfakianos, MD, outlines the scientific rationale for combining systemic immunotherapy with BCG in the BCG-naïve NMIBC setting.

Although BCG has been the standard of care for decades and remains the most effective available treatment, outcomes remain suboptimal for many patients.

Kristen R. Scarpato, MD, MPH, discusses what level of evidence is necessary to shift the standard of care in BCG-naive NMIBC.

Daniel A. González Padilla, MD, emphasized that shared decision-making is essential, as patients must weigh potential benefits against adverse effects and the possibility of ultimately requiring radical cystectomy or clinical trial participation.

Kristen R. Scarpato, MD, MPH, discusses the potential role of emerging immunotherapy-based combinations in the treatment of BCG-naive, high-risk non–muscle invasive bladder cancer.

Matthew D. Galsky, MD, discusses what is needed for successful integration of BCG/ICI combinations in BCG-naive non–muscle invasive bladder cancer.

A subgroup analysis of the POTOMAC trial showed that durvalumab plus BCG I+M had consistent safety and efficacy in older patients with BCG-naïve high-risk NMIBC.

Bogdana Schmidt, MD, MPH, identified several subgroups most likely to harbor occult systemic disease and therefore potentially benefit from adding immunotherapy to BCG:

Despite promising candidates across tumor, immune, and systemic marker categories, no biomarker yet reliably predicts BCG response or identifies which NMIBC patients would benefit from adding checkpoint inhibitor therapy—a gap that limits informed shared decision-making and broader adoption of IO-BCG combinations despite positive trial data.

Song Jiang, MD, PhD, discusses the balance between efficacy and safety data when considering the role for BCG/ICI combinations in BCG-naive NMIBC.

Song Jiang, MD, discusses evolving biomarker approaches that may redefine care in NMIBC.

Maria Carmen Mir, MD, PhD, discusses how phase 3 trials of BCG/ICI combinations are shaping the future of high-risk NMIBC management, emphasizing the need for a more selective approach to treatment intensification.