Dr Meeks on a Real-World Study of BCG Retreatment After BCG Failure in NMIBC

“The bottom line is that 71% [of patients experienced] recurrence within 2 years…and by a year, roughly half of [patients] had already had a recurrence of their cancer. So, [BCG is] probably not the best therapy for most [patients]. [This] opens a window up for more treatment options.”

Joshua J. Meeks, MD, PhD, the Edward M. Schaeffer, MD, PhD Professor of Urology and an associate professor of Urology, Biochemistry and Molecular Genetics at Northwestern University Feinberg School of Medicine, discussed findings from a real-world registry study evaluating the outcomes of BCG rechallenge in patients with non-muscle–invasive bladder cancer (NMIBC) who experienced disease recurrence within 12 months of initial BCG therapy.

Meeks began by detailing the clinical context for this study. He noted that BCG discontinuation is common in community practice, occurring for a variety of reasons including inadequate dosing or poor patient tolerability. Although BCG rechallenge beyond 12 months of recurrence is generally considered safe and associated with outcomes approaching those of BCG-naive patients, the safety and efficacy of rechallenge within that 12-month window has remained poorly defined, he explained

To address this question, Meeks obtained data from the AQUA registry, a large real-world evaluation encompassing 79,190 patients with NMIBC, of whom 26,198 received BCG. Among those patients, 2632 experienced a recurrence within the 12-month window following BCG therapy, he noted. Within this subgroup, 616 patients proceeded to BCG rechallenge and served as the primary study cohort, while 409 received BCG as their initial therapy following recurrence and were classified as BCG-exposed or BCG-unresponsive.

Data presented during the 2026 American Urological Association (AUA) Annual Meeting showed that outcomes in the rechallenge cohort were poor. In total, 49% of patients had already experienced disease recurrence by 1 year; by 2 year, this percentage increased to 71%, Meeks said. These findings suggest that BCG rechallenge within the 12-month window offers limited durable benefit for most patients in this setting, he added

Ultimately, these real-world data underscore a meaningful unmet need in BCG-unresponsive NMIBC and create an opportunity for the development and adoption of alternative therapeutic strategies for patients who are unlikely to derive sustained benefit from BCG rechallenge, Meeks concluded.