POTOMAC
In BCG-naïve high-risk NMIBC after TURBT, does adding durvalumab to BCG induction and maintenance improve disease-free survival?
Key reported outcomes
Values are reproduced from the linked sources. Bars are a visual aid and are scaled within each outcome row; do not compare bar lengths across different endpoints.
At median follow-up of 60.7 months, DFS events occurred in 20% with durvalumab plus BCG induction/maintenance versus 29% with BCG induction/maintenance alone (HR 0.68, 95% CI 0.50–0.93; P=0.015). Grade 3–4 treatment-related adverse events were 21% versus 4%.
Critical appraisal
Open-label phase III trial. The event percentages are reported analysis proportions, not a fixed-time Kaplan–Meier estimate; do not use them to calculate an NNT without a common time horizon. Immune toxicity is added to BCG-related urinary and systemic effects.
Absolute-effect discipline: NNT/NNH is not calculated unless a defensible absolute difference and a common time horizon are available. Median survival differences and hazard ratios alone are not converted into NNT.
Current-practice context
Reviewed 2026-10-14; this is a dated evidence-context note, not a substitute for local guidelines or individual clinical judgement.
US FDA approval of durvalumab plus BCG for BCG-naïve high-risk NMIBC was granted on 28 May 2026. Preserve the distinction between this approved combination and the separate durvalumab-plus-BCG-induction-only trial arm.
Freshness status: this page has a dated context and source links, but is not a claim that every relevant guideline or subsequent publication has been exhaustively reviewed.