Akinori Minato: Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; a-minato@med.uoeh-u.ac.jp.
Nobuki Furubayashi: Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Toshihisa Tomoda: Department of Urology, Oita Prefectural Hospital, Oita, Japan.
Hiroyuki Masaoka: Department of Urology, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
Yoohyun Song: Department of Urology, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
Yoshifumi Hori: Department of Urology, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
Keijiro Kiyoshima: Department of Urology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan.
Takahito Negishi: Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kentaro Kuroiwa: Department of Urology, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
Narihito Seki: Department of Urology, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
Ikko Tomisaki: Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Motonobu Nakamura: Department of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kenichi Harada: Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Naohiro Fujimoto: Department of Urology, Kurate Hospital, Kurate, Japan.
BACKGROUND/AIM: This study retrospectively evaluated whether enfortumab vedotin (EV) monotherapy is effective as a late-line treatment according to prior treatment type in patients with advanced urothelial carcinoma (UC). PATIENTS AND METHODS: We assessed consecutive patients from the Uro-Oncology Group in the Kyushu study population with lower and upper urinary tract cancer treated with EV monotherapy after platinum-based chemotherapy and immune checkpoint inhibitor therapy failure between December 2021 and March 2024. In particular, patients receiving avelumab maintenance or pembrolizumab therapy before EV for advanced UC were analyzed and compared according to the response rate, progression-free survival (PFS), and overall survival (OS). RESULTS: Of the 80 enrolled patients, 31 and 49 received avelumab and pembrolizumab before EV therapy, respectively. The avelumab and pembrolizumab groups had comparable objective response rates (48.4% vs. 44.9%, p=0.820) and disease control rates (77.4% vs. 67.3%, p=0.448). These two groups showed no significant difference in PFS from the initiation of EV (median: 6.4 months vs. 4.2 months, p=0.184); meanwhile, the avelumab group had better OS from the initiation of EV than the pembrolizumab group (median: 16.0 months vs. 10.2 months, p=0.019). Moreover, the median OS after first-line chemotherapy initiation was longer in the avelumab group than in the pembrolizumab group (40.3 months vs. 24.7 months, p=0.054). On multivariate analysis, avelumab maintenance therapy before EV reduced the mortality risk by 47% (95% confidence interval=0.27-1.03; p=0.059). CONCLUSION: EV monotherapy after avelumab maintenance therapy provides favorable survival outcomes in patients with advanced UC.