JAVEMACS: a real-world study of avelumab maintenance therapy for advanced urothelial carcinoma in Japan

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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.

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