Objectives: Oncological outcomes in patients with urothelial carcinoma treated with avelumab maintenance therapy or conventional platinum-based first-line chemotherapy were compared in real-world practice.
Methods: Outcomes in patients with advanced urothelial carcinoma treated with platinum-based first-line chemotherapy without avelumab (chemo group, n = 300) or avelumab maintenance therapy (avelumab group, n = 85) between March 2004 and September 2024 were retrospectively evaluated. Overall survival (OS) in the chemo and avelumab groups was stratified by the number of cycles of first-line chemotherapy. The primary outcome was OS among patients without progressive disease (non-PD) at the cycle-4 assessment (the standard-switch cohort). The secondary outcome was OS among patients with non-PD at the cycles-2 to 3 assessment (the early-switch cohort).
Results: In the standard-switch cohort (non-PD at cycle 4), the chemo and avelumab groups comprised 122 and 47 patients, respectively; median OS was significantly longer with avelumab than with chemo (70 vs. 26 months; p = 0.015). In the early-switch cohort (non-PD at cycles 2-3), the chemo and avelumab groups comprised 104 and 35 patients, respectively; median OS was significantly longer with avelumab than with chemo (33 vs. 13 months; p = 0.002). A multivariable Cox regression analysis revealed that avelumab administration was significantly associated with a reduced risk of OS (hazard ratio, 0.37; p < 0.001). The retrospective design is a limitation of this study.
Conclusion: Avelumab maintenance appeared to improve outcomes across cycles 2-3 and ≥ 4, though residual confounding cannot be excluded.
Keywords: avelumab; chemotherapy; immunotherapy; overall survival; urothelial carcinoma.
© 2025 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.