Bacillus Calmette-Guérin (BCG) with or without immune checkpoint blockade in BCG-naïve high-risk non-muscle-invasive bladder cancer: A systematic review and reconstructed individual patient data meta-analysis.
Mohammed Amine Saâd, Abdelkarim Antari, Imad Taleb et al.
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In 30 seconds
This systematic review and reconstructed individual patient data meta-analysis pooled three phase 3 randomised trials involving 2,590 patients with BCG-naïve high-risk non-muscle-invasive bladder cancer. It compared immune checkpoint inhibition plus BCG with BCG alone. Adding checkpoint inhibition to BCG induction and maintenance improved event-free survival (HR 0.77, 95% CI 0.64-0.93; p = 0.006), whereas adding it to induction-only BCG did not (HR 1.03, 95% CI 0.85-1.25; p = 0.754). Overall survival data were immature, and severe adverse events were more frequent with combination therapy.
Key findings
- Across three trials (n = 2590), checkpoint inhibition plus BCG induction and maintenance improved event-free survival versus BCG alone (HR 0.77, 95% CI 0.64-0.93; p = 0.006).
- Checkpoint inhibition with induction-only BCG showed no event-free survival benefit (HR 1.03, 95% CI 0.85-1.25; p = 0.754).
- Grade ≥ 3 adverse events occurred in 24.5% with combination therapy versus 6.1% with BCG alone.
- Overall survival results were immature (HR 0.90; p = 0.36).
Why it matters
The findings suggest that the event-free survival benefit of adding immune checkpoint inhibition in this population depends on BCG maintenance, rather than induction alone. The higher frequency of severe adverse events is relevant when weighing potential disease control against treatment burden. Because overall survival data remain immature, the reported benefit is currently demonstrated for event-free survival, not survival.
What to keep in mind
The analysis reconstructed individual patient data from published Kaplan-Meier curves rather than using original patient-level trial data. Overall survival data were immature.