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

Abstract

ObjectiveIn December 2021, enfortumab vedotin (EV), an antibody‐drug conjugate directed against nectin‐4, was approved in Japan as a new treatment after platinum‐containing chemotherapy and PD‐1/PD‐L1 inhibitors. This study evaluated, using real‐world data, the efficacy and safety of EV therapy in patients with metastatic urothelial carcinoma (mUC).Materials and methodsFifty‐five patients with mUC who discontinued pembrolizumab therapy due to disease progression between June 2018 and April 2023 at Yokohama City University Hospital were evaluated retrospectively. Of the 55 patients, 25 received EV therapy (EV group) and 30 did not (non‐EV group). All patients who underwent EV therapy were diagnosed with disease progression after the approval of EV in Japan.ResultsThe median (range) follow‐up period after pembrolizumab discontinuation was 6.3 (0.7–31.1) months. There were eight (32.0%) deaths due to cancer in the EV group and 27 (90.0%) in the non‐EV group. The overall survival (OS) after pembrolizumab discontinuation was not reached in the EV group versus 2.6 months in the non‐EV group (p < 0.001). A multivariate analysis revealed that EV therapy (EV vs. non‐EV group; hazard ratio 0.26; 95% confidence interval 0.16–0.41; p < 0.001) was an independent prognostic factor for OS.ConclusionEV prolonged OS in mUC following pembrolizumab therapy in real‐world data.

Enhancing Therapeutic Efficacy and Safety of Immune Checkpoint Inhibition for Bladder Cancer: A Comparative Analysis of Injectable vs. Intravesical Administration

“…In 2021, the US FDA approved injectable immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 interaction as a second-line treatment for cisplatin-ineligible patients with metastatic urothelial carcinoma [1]. These include the use of anti-PD1 checkpoint antibody (pembrolizumab) monotherapy for high-risk non-muscle invasive BC unresponsive to BCG [11] or together with enfortumab vedotin [12] as well as nivolumab [13], pembrolizumab in the platinum-refractory BC patients. However, the association of injectable ICIs with higher incidence of adverse events [14], see Table 1, motivates the question: whether the therapeutic index of IC1s could be improved via intravesical administration in BC patents [15].…”