ArticleTargeted oncology2026
Prevalence of PD-L1-High Tumor Expression and Association with First-Line Treatment Outcomes in Patients with Metastatic Urothelial Carcinoma: Results from a Prospective Observational Cohort Study.
Article in Targeted oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03788746 (A Prospective, Non-Interventional Study to Assess the Prevalence of PD-L1 Expression in the First-Line Setting of Locally Advanced/Unresectable or Metastatic Urothelial Carcinoma), which is not on this map. Not yet cited in PubMed.
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A Prospective, Non-Interventional Study to Assess the Prevalence of PD-L1 Expression in the First-Line Setting of Locally Advanced/Unresectable or Metastatic Urothelial Carcinoma
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12 authors.
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Abstract
backgroundProgrammed death-ligand 1 (PD-L1) expression has been studied extensively in clinical trials of metastatic urothelial carcinoma.
objectiveWe aimed to provide information on the prevalence of tumor PD-L1 expression and treatment outcomes in patients with metastatic urothelial carcinoma in a real-world setting.
methodsPREVAIL (NCT03788746) enrolled patients with metastatic urothelial carcinoma undergoing systemic first-line treatment at US community oncology practices. The primary endpoint was the prevalence of pretreatment tumor PD-L1-high expression using an immunohistochemistry antibody for PD-L1 (SP263) [Roche Diagnostics]. Secondary endpoints included treatment patterns and association between PD-L1 expression and objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
resultsAmong 139 patients, the pretreatment prevalence of PD-L1-high expression was 53.2% (95% confidence interval 44.6-61.7). Forty-seven patients (33.8%) received anti-PD-L1/anti-programmed death 1 agents alone as first-line therapy. In all evaluable patients, ORR was 50.9%, median PFS was 15.1 months, and median OS was 25.4 months from the first dose of first-line therapy. There was no significant difference in PFS (hazard ratio 0.72; 95% confidence interval 0.34-1.52; p = 0.385) or OS (hazard ratio 0.71; 95% confidence interval 0.44-1.15; p = 0.164) in patients with pretreatment PD-L1-high versus PD-L1-low expression. Objective response rate was similar between patients with PD-L1-high (17/33; 51.5%) and PD-L1-low (12/24; 50.0%) expression.
conclusionsIn this observational study, more than half of patients had high pretreatment tumor PD-L1 expression. There was no significant association between PD-L1 status and ORR, PFS, or OS with any first-line therapy, although definitive conclusions cannot be made because of the limited sample size.
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