J‐AVENUE: A retrospective, real‐world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first‐line maintenance therapy in Japan

Objectives The JAVELIN Bladder 100 phase 3 trial showed that avelumab first‐line maintenance + best supportive care significantly prolonged overall survival and progression‐free survival versus best supportive care alone in patients with advanced urothelial carcinoma who were progression‐free following first‐line platinum‐based chemotherapy. We report findings from J‐AVENUE (NCT05431777), a real‐world study of avelumab first‐line maintenance therapy in Japan. Methods Medical charts of patients with advanced urothelial carcinoma without disease progression following first‐line platinum‐based chemotherapy, who received avelumab maintenance between February and November 2021, were reviewed. Patients were followed until June 2022. The primary endpoint was patient characteristics; secondary endpoints included time to treatment failure and progression‐free survival. Results In 79 patients analyzed, median age was 72 years (range, 44–86). Primary tumor site was upper tract in 45.6% and bladder in 54.4%. The most common first‐line chemotherapy regimen was cisplatin + gemcitabine (63.3%). Median number of chemotherapy cycles received was four. Best response to chemotherapy was complete response in 10.1%, partial response in 58.2%, and stable disease in 31.6%. Median treatment‐free interval before avelumab was 4.9 weeks. With avelumab first‐line maintenance therapy, the disease control rate was 58.2%, median time to treatment failure was 4.6 months (95% CI, 3.3–6.4), and median progression‐free survival was 6.1 months (95% CI, 3.6–9.7). Conclusions Findings from J‐AVENUE show the effectiveness of avelumab first‐line maintenance in patients with advanced urothelial carcinoma in Japan in clinical practice, with similar progression‐free survival to JAVELIN Bladder 100 and previous real‐world studies, supporting its use as a standard of care.