Enfortumab vedotin prolonged overall survival in metastatic urothelial carcinoma compared to standard of care following pembrolizumab treatment

Abstract

Abstract Objective In December 2021, enfortumab vedotin (EV), an antibody-drug conjugate (ADC) directed against nectin-4, was approved as a new treatment after platinum-containing chemotherapy and PD-1/PD-L1 inhibitors in Japan. This study aimed to evaluate, using real-world data, the efficacy and safety of EV therapy in patients with metastatic urothelial carcinoma (mUC). Materials and Methods Exactly 50 patients with mUC who discontinued pembrolizumab therapy due to disease progression between June 2018 and December 2022 at Yokohama City University Hospital were retrospectively evaluated. Of the 50 patients, 20 received EV therapy (EV group) and 30 received standard care (SOC group). All patients who underwent EV therapy were diagnosed with disease progression after EV approval in Japan. Results The median (interquartile range) follow-up period after pembrolizumab discontinuation was 4.2 (1.3–11.3) months. There were six (30%) deaths due to cancer in the EV group, with 27 (90.0%) in the SOC group. The overall survival (OS) after pembrolizumab discontinuation was not reached versus 2.6 months (p < 0.001) in the EV and SOC groups. Multivariate analysis revealed that lactate dehydrogenase levels (hazard ratio [HR] 1.01; 95% confidence interval [CI] 1.00–1.05; p = 0.04) and treatment after pembrolizumab (EV versus SOC group; HR 0.10; 95%CI 0.04–0.29; p < 0.001) were independent prognostic factors for OS. Conclusion EV prolonged OS in mUC patients compared with the standard of care following pembrolizumab treatment.