The role of immune checkpoint inhibitors in the management of NMIBC: a scoping review of current status and future direction

This is the authors' abstract. We don't add key points for this paper.

INTRODUCTION: Non-muscle invasive bladder cancer (NMIBC) is a malignancy with a significant recurrence and progression risk. While intravesical Bacillus Calmette-Guérin (BCG) has remained the standard of care for decades, limitations in efficacy, tolerability, and global supply underscore the need for novel therapeutic strategies. Many patients relapse after BCG and are offered radical cystectomy, a highly morbid operation which some are unfit for or decline. Immune checkpoint inhibitors (ICIs) have revolutionized neoadjuvant and advanced bladder cancer therapy. This has driven interest in ICIs as bladder-sparing alternatives in BCG-unresponsive high-risk NMIBC (HR-NMIBC). AREAS COVERED: This scoping review (MEDLINE, Embase, ClinicalTrials.gov; 2015-2025) explores the emerging role of ICIs in NMIBC. It summarizes data from completed and ongoing trials in both BCG-naïve and BCG-unresponsive settings, highlighting key efficacy and safety outcomes. Special emphasis is given to combination approaches and novel delivery routes. EXPERT OPINION: Checkpoint inhibition represents a potentially transformative advance in the bladder-sparing management of NMIBC, particularly in patients unfit for or refusing radical cystectomy. However, widespread adoption will require robust phase III data combined with optimal patient selection to temper concerns regarding toxicity and cost. Ongoing research into combination regimens and local delivery may refine risk-benefit profiles and personalize treatment in the near future.