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. 2025 Jun 13.
doi: 10.1007/s12094-025-03950-w. Online ahead of print.

Avelumab maintenance in advanced urothelial carcinoma: real-world data from Northern Spain (AVEBLADDER study)

Marta Sotelo  1 , Mireia Pelaez  2 , Laura Basterretxea  3 , Estrella Varga  4 , Ricardo Sánchez-Escribano  5 , Eduardo Pujol Obis  6 , Carmen Santander  7 , Mireia Martínez Kareaga  8 , Mikel Arruti Ibarbia  9 , Inmaculada Rodríguez Ledesma  10 , Carlos Álvarez Fernández  11 , Pablo Piedra  4 , Verónica Calderero Aragón  12 , Nuria Lainez  4 , Juan Antonio Verdún Aguilar  13 , Irene Gil Arnáiz  14 , Ricardo Fernández  15 , Cristina Mazas  2 , Ignacio Duran  16
Affiliations

Avelumab maintenance in advanced urothelial carcinoma: real-world data from Northern Spain (AVEBLADDER study)

Marta Sotelo et al. Clin Transl Oncol. .

Abstract

Background: Before the incorporation of enfortumab vedotin with pembrolizumab, the standard of care for patients with locally advanced or metastatic urothelial carcinoma who do not progress after platinum-based chemotherapy was avelumab maintenance therapy, as demonstrated by the JAVELIN 100 trial. However, real-world European data remain scarce.

Patients and methods: AVEBLADDER is a retrospective study conducted at 14 hospitals in Northern Spain, including patients with locally advanced or metastatic urothelial carcinoma diagnosed between January 2021 and June 2023. Outcomes of overall survival (OS) and progression-free survival (PFS) were analyzed for patients treated with platinum-based chemotherapy, with and without subsequent avelumab maintenance therapy. non-avelumab patients. Median PFS was 11.33 months (95% CI: 10-13.6) with avelumab and 6.43 months (95% CI: 6-7.6) without. One-year OS probabilities were 81.6% vs. 45.6% (p < 0.001) in the avelumab and non-avelumab groups, respectively. No unexpected toxicities were reported.

Conclusions: Despite proven survival benefits, avelumab uptake in real-world practice is limited by barriers like access, reimbursement, and awareness. These findings align with JAVELIN 100 and underscore the need for further real-world studies to address treatment disparities.

Keywords: Avelumab; Locally advanced/metastatic urothelial cancer; Real-world data; Treatment outcomes.

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Conflict of interest statement

Declarations. Conflict of interest: Astellas has contributed a grant to support a portion of the program’s cost, but they have not exerted any influence or input on the research program. Ethical approval: The study was approved by the Institutional Review Board and Ethics Committee of all the participant centers. Informed consent: Informed consent was obtained whenever required by the Spanish Law.

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