H Kitamura, T Kobayashi, Y Endo, M Ikeda, K Yonemori, M Nakayama, A Fujihara, T Abe, F Shimizu, K Fujimoto, T Nakagawa, S Hatakeyama, K Murakami, K Nishihara, D Ikarashi, N Masumori, S Naito, K Fujita, N Hayakawa, T Hara, N Miura, T Negishi, J Yatsuda, M Kobayashi, N Nishiyama, R Taoka, J Furukawa, M Shono, S Shirotake, E Kikuchi
Results from JAVEMACS confirm the effectiveness of avelumab maintenance in real-world clinical practice in Japan, supporting its recommendation for patients with la/mUC without disease progression following 1L PBC. This treatment sequence followed by 2L EV appeared to be associated with encouraging long-term outcomes in this real-world population.
BACKGROUND: Avelumab maintenance therapy was approved in Japan in February 2021 for patients with unresectable locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression after platinum-based chemotherapy (PBC). We report the primary analysis from the JAVEMACS chart review study of avelumab maintenance therapy in Japan.
MATERIALS AND METHODS: This multicenter, retrospective study collected data from medical charts of patients with la/mUC who received avelumab maintenance after first-line (1L) PBC.
RESULTS: Between February 2021 and December 2023, 350 patients received avelumab maintenance; median age was 73 years and most were male (74.0%). Prior 1L PBC was cisplatin-gemcitabine in 56.0% and carboplatin-gemcitabine in 33.1%; 28.6% were cisplatin eligible and 52.9% were cisplatin ineligible/platinum eligible. At data cut-off (June 2024), 67 patients (19.1%) were still receiving avelumab. Among 283 patients who discontinued avelumab, 200 (70.7%) received second-line (2L) treatment. In the overall population, median overall survival (OS) from avelumab initiation was 31.8 months [95% confidence interval (CI) 24.6 months-not estimable (NE)]. In subgroups who received 2L enfortumab vedotin (EV) (n = 133), PBC (n = 41), or pembrolizumab (n = 17), median OS from the start of 2L treatment was 17.8 months (95% CI 11.9 months-NE), 15.1 months (95% CI 11.6 months-NE), and 15.6 months (95% CI 8.6-21.3 months), respectively. Limitations include the study's retrospective nature.
CONCLUSIONS: Results from JAVEMACS confirm the effectiveness of avelumab maintenance in real-world clinical practice in Japan, supporting its recommendation for patients with la/mUC without disease progression following 1L PBC. This treatment sequence followed by 2L EV appeared to be associated with encouraging long-term outcomes in this real-world population.