Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study

Abstract

ObjectivesTo explore the characteristics of patients and assess the effectiveness of enfortumab vedotin (EV) in those with treatment‐resistant advanced urothelial cancer in a real‐world setting.Patients and MethodsA multicenter observational study was conducted on 103 evaluable patients with advanced urothelial cancer who received EV. Outcomes were assessed by radiographic response, progression‐free survival (PFS), and overall survival (OS), with treatment‐related adverse events (trAEs). Radiographic response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1, while trAEs were studied in line with Common Terminology Criteria for Adverse Events version 5.0.ResultsThe median follow‐up was 8.9 months (range, 0.1–16.4). The observed objective response rate was 50.5%. The median PFS was 6.0 months (95% CI: 4.7–9.8), and the median OS was 14.5 months (95% CI: 12.4–not reached). Out of the 103 patients, 19 (18.4%) had an Eastern Cooperative Oncology Group performance status of 2 or more, 14 (14.7%) had an non‐urothelial carcinoma histology, and 40 (38.3%) had at least one pre‐existing comorbidity. There were 26 (25.2%) patients who reported 49 trAEs, with 9 (18.3%) being grade 3 or higher. The most common trAEs included rash, occurring in 18.4%.ConclusionsThis study describes the characteristics and outcomes of patients with previously treated advanced urothelial cancer receiving EV. The findings demonstrate that EV showed robust anti‐tumor activity and had manageable safety profiles outside the clinical trial setting.

C-Reactive Protein Is a Potential Prognostic Marker in Patient with Advanced or Metastatic Urothelial Carcinoma Treated with Enfortumab Vedotin: A Multi-Center Retrospective Study

“…In Japan, as the largest retrospective real-world study, Fukuokaya et al enrolled 103 evaluable patients who received EV treatment. The ORR was found to be 50.5%, the median PFS was 6.0 months (95% CI: 4.7-9.8), and the median OS was 14.5 months (95% CI: 12.4-NR) with acceptable AE profiles [23]. Such data highlighted the acceptable safety profile and oncological outcomes of EV therapy in patients with la/mUC.…”

Enfortumab vedotin prolongs overall survival in metastatic urothelial carcinoma following pembrolizumab therapy in real‐world data

“…2,3 In mUC Japanese patients, few reported efficacy and tolerability of EV therapy. [4][5][6] Our study yielded three results. First, we determined the prognostic factors for OS after pembrolizumab discontinuation.…”

“…In non-EV era, several retrospective studies reported that ECOG-PS was significantly associated with OS after pembrolizumab discontinuation using the multivariate analysis. 5,6 It may be important to keep good ECOG-PS for continuing systemic therapy after pembrolizumab discontinuation. In our cohort, all patients with poor ECOG-PS (≥2) in the non-EV group were unable to receive systemic therapy after pembrolizumab, while all patients with poor ECOG-PS (≥2) were able to receive EV therapy.…”