JAVEMACS-D: claims database analysis of avelumab maintenance therapy for advanced urothelial carcinoma in Japan

JAVEMACS-D was an observational, retrospective study describing real-world characteristics, treatment patterns, and outcomes in patients with advanced urothelial carcinoma (aUC) treated with avelumab maintenance after first-line platinum-based chemotherapy (PBC) in Japan using a large claims database (Medical Data Vision). Between February 2021 and April 2023, 773 patients received avelumab maintenance; median age was 74 years, primary tumor site was bladder in 59.9% and renal pelvis/ureter in 42.7%, and first-line PBC was cisplatin-gemcitabine in 61.3% and carboplatin-gemcitabine in 36.4%. Avelumab maintenance started in 2021 in 289 patients (37.4%) and in 2022 or later in 484 (62.6%). At data cutoff (October 2023), median follow-up was 19.3 months, and 22.0% of patients were still receiving avelumab. Among 394 patients (51.0%) who received second-line treatment, the most common was enfortumab vedotin (EV) in 47.0%. Median time to treatment failure (TTF; time from start of avelumab maintenance to discontinuation) was 4.5 months (95% CI 3.8-5.2). Median TTF2 (time from start of avelumab to discontinuation of subsequent treatment) was 10.1 months (95% CI 8.7-11.0). JAVEMACS-D represents the largest real-world dataset of avelumab maintenance therapy for aUC reported to date. Data provide insights about patient characteristics, treatment patterns, and outcomes within an evolving treatment landscape.