KEYNOTE-052
What durable activity does first-line pembrolizumab monotherapy provide for cisplatin-ineligible advanced urothelial carcinoma?
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.
24%
28.9%
11.3 months
Initial centrally assessed ORR was 24%. With median follow-up of 56.3 months, confirmed ORR was 28.9%, complete response 9.5%, and median OS 11.3 months; responses could be durable.
Critical appraisal
Single-arm phase II evidence cannot establish superiority over contemporary regimens. PD-L1 expression enriched response in the original setting, and treatment selection rules have changed as first-line options evolved.
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.
This is foundational historical evidence for pembrolizumab in cisplatin-ineligible disease, not a default contemporary first-line choice for every patient. In 2026, assess eligibility for enfortumab vedotin–pembrolizumab, platinum-based combinations, PD-L1/label criteria and contraindications under local guidelines.
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.