Real-world outcomes of enfortumab vedotin and pembrolizumab in metastatic urothelial carcinoma at an urban academic center

Document Type

Conference Proceeding

Publication Date

9-18-2025

Publication Title

Cancer Epidemiol Biomarkers Prev

Keywords

Oncology, Public, Environmental & Occupational Health

Abstract

Background: Urothelial carcinoma is the 6th most common cancer in the U.S., accounting for 4.2% of new cases. The current first-line treatment landscape for metastatic disease includes Enfortumab Vedotin (a Nectin-4-directed antibody-drug conjugate (ADC)) plus Pembrolizumab, based on EV-302 data showing improved progression-free and overall survival over platinum-based chemotherapy. This study evaluates real-world outcomes of this regimen in an urban academic center serving a more diverse population than those typically represented in clinical trials. Methods: This retrospective study assesses Enfortumab Vedotin/Pembrolizumab combination therapy using our institutional bladder cancer database. Patients were stratified by gender, race, smoking status, and line of treatment. Kaplan-Meier estimates for overall survival (OS) and time to progression (TTP) were compared across these groups using log-rank tests. Statistical analysis was performed using Chi-square tests for categorical variables, and time to event analysis was performed using Kaplan-Meier method. A p-value <0.05 was used for statistical significance. TTP was defined as radiographic progression, clinical progression, or death. Maintenance therapy due to toxicity or completion was not considered a clinical progression. Results: A total of 46 patients were included in the study. By race, 10 (22%) were African American (AA) and 36 (78%) were Caucasian. Eighteen patients (39%) were female and 28 (61%) were male. Thirty-three patients (72%) were current or former smokers, while 13 (28%) were non-smokers. EV/P was administered as first-line therapy in 37 patients (80%), second-line in 6 patients (13%), and third-line in 3 patients (7%). Median overall survival (OS) and time to progression (TTP) was not reached when stratified by race. One-year OS probability was 61.7% for African Americans and 68.2% for Caucasians (p = 0.688). Six-month TTP probability was 39.4% for African Americans versus 63.3% for Caucasians (p = 0.139). No statistically significant differences in OS or TTP were observed when stratified by gender, line of treatment or smoking status. Conclusions: Our study highlights differences in treatment outcomes among patients receiving Enfortumab Vedotin and Pembrolizumab for metastatic urothelial carcinoma at our institution. While evaluating overall survival, African American and Caucasian patients showed a 1-year survival probability of 61.7% and 68.2%, respectively. A more notable difference was observed in 6-month time to progression (TTP) probability: 39.4% for African Americans vs. 63.3% for Caucasians. A key limitation of this study is the small sample size and retrospective design, which limits the statistical power of our findings. As EV/P becomes more widely adopted as first-line therapy, we plan to expand our analysis with a larger cohort from both our institution and affiliated satellite centers to further validate these early observations.

Volume

34

Issue

9

First Page

C76

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