Survival and Safety Outcomes of Avelumab Maintenance Therapy for Advanced Urothelial Carcinoma from a Single-Center Experience.

Background/aim: Avelumab maintenance therapy following first-line platinum-based chemotherapy is reportedly effective against advanced urothelial carcinoma (UC). However, this therapy, including its survival outcome, remains poorly investigated in a real-world setting in Japan.

Patients and methods: This study retrospectively evaluated the clinical outcomes of avelumab maintenance therapy in patients with advanced lower- and upper-tract UC after no progression on first-line platinum-based chemotherapy at our institution between May 2021 and August 2024. Efficacy, survival, and safety analyses were performed starting from avelumab introduction.

Results: In total, 22 patients were enrolled, of which 7 (31.8%) were female, 9 (40.9%) had performance status score ≥1, and 9 (40.9%) had upper-tract UC. The objective response and disease control rates were 4.5% and 50.0%, respectively. While receiving avelumab, no patients experienced immune-related adverse events (irAEs) of grade ≥3. The median progression-free survival (PFS) and overall survival were 3.3 and 22.2 months, respectively. When comparing median PFS of patients with a complete or partial response to prior platinum-based chemotherapy to the patients with stable disease, the first had significantly longer PFS (4.0 months, 95% confidence interval=2.3-10.1 vs. 2.2 months, 95% confidence interval=0.9-3.9; p=0.034). The PFS did not significantly differ between patients with and without irAEs or infusion-related reaction.

Conclusion: Avelumab maintenance therapy demonstrated favorable survival outcomes and tolerability in patients with advanced UC in daily practice.