CheckMate 901
In previously untreated unresectable or metastatic urothelial carcinoma, does nivolumab plus gemcitabine–cisplatin followed by nivolumab improve survival over gemcitabine–cisplatin?
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.
Median OS was 21.7 versus 18.9 months (HR 0.78, 95% CI 0.63–0.96; P=0.0171). Median PFS was 7.9 versus 7.6 months (HR 0.72, 95% CI 0.59–0.88; P=0.0012); response rates were 57.6% versus 43.1%.
Critical appraisal
The comparator was cisplatin–gemcitabine, not the current antibody–drug-conjugate plus immunotherapy option. Nivolumab was continued as maintenance; interpret the result as a treatment strategy. Immune and chemotherapy toxicities must be considered.
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.
FDA-approved in the US in March 2024 for first-line unresectable/metastatic UC. Current first-line choice has evolved with enfortumab vedotin–pembrolizumab; cisplatin–gemcitabine plus nivolumab remains a relevant option for selected patients depending on eligibility, access and contraindications.
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.