Addition of immune checkpoint inhibitors to intravesical BCG for high‐risk BCG‐naïve non‐muscle invasive bladder cancer: Systematic review and meta‐analysis

Objective: The objective of this study is to assess the efficacy, safety and change in quality of life associated with ICI-BCG (I + M) compared to BCG (I + M) in patients with BCG-naïve HR-NMIBC. Material and Methods: A systematic search was run on PubMed, Embase and CENTRAL from inception to 29 October 2025. Phase 3 randomized controlled trials comparing safety, efficacy and quality of life (QOL) for patients with BCG-naïve HR-NMIBC receiving ICI-BCG (I + M) versus BCG (I + M): hazard ratios (HR) and 95% confidence interval (95% CI) for HG-RFS (high-grade recurrence free survival), odds ratio (OR) and 95% CI for Grade ≥3 treatment-related adverse events (G3 + TRAEs), and mean difference (MD) and 95% CI for changes in quality of life (QOL measured using EORTC QLQ C30). A priori defined subgroups included presence of CIS, presence of papillary tumours, age <65 or ≥65 years, male/female, and BCG strain. Results: < 1). Risk of bias was low in all included studies. Conclusion: This pooled analysis provides data for patient-specific counselling on the use of ICI-BCG (I + M) for BCG-naive HR-NMIBC.