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.
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.
Pooled results indicated that ICI-BCG (I + M) was not associated with a reduction in HG-RFS (HR: 0.78; 95% CI: 0.59-1.02). However, on sensitivity analysis excluding ALBAN (for differences in trial design and patients included), ICI-BCG (I + M) was associated with a reduction in HG-RFS (HR: 0.68; 95% CI: 0.54-0.85) with an absolute risk reduction of 4.4-7.3% in 36-month HG-RFS. ICI-BCG (I + M) was associated with an increased risk of G3 + TRAEs (OR: 4.76; 95% CI: 3.01-7.53). ICI-BCG (I + M) was associated with a non-clinically significant decline in QOL (MD: -3.25; 95% CI: -5.11 to -1.39). Heterogeneity between trials was minimal (τ 2 < 1). Risk of bias was low in all included studies.
This pooled analysis provides data for patient-specific counselling on the use of ICI-BCG (I + M) for BCG-naive HR-NMIBC.
BJUI compass. 2026 Mar 31*** epublish ***
Renil S Titus, Carlos Riveros, Eusebio Luna Velasquez, David-Dan Nguyen, Suran Somawardana, Amar Singh, Dharam Kaushik, Guru Sonpavde, Alexandre Zlotta, Girish Kulkarni, Srikala S Sridhar, Christopher J D Wallis, Raj Satkunasivam
Department of Urology Houston Methodist Hospital Houston Texas USA., Division of Urology, Department of Surgery University of Toronto Toronto Ontario Canada., Rice University Houston Texas USA., Southwestern University Georgetown Texas USA., Advent Health Cancer Institute Orlando Florida USA., Division of Medical Oncology, Princess Margaret Cancer Centre, University Health Network University of Toronto Toronto Ontario Canada.