Updated Results from AVENANCE: Real-World Effectiveness of Avelumab First-Line Maintenance (1LM) in Patients with Advanced Urothelial Carcinoma (aUC) and Analysis of Second-Line Treatment

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Aims and Objectives: Previous results from the noninterventional, ambispective AVENANCE study (NCT04822350) showed the effectiveness and safety of avelumab 1LM in patients with aUC in France. We report updated data and analyses by second-line treatment. Materials and Methods: Eligible patients had aUC without progression after 1L platinum-based chemotherapy and previous, ongoing, or planned avelumab 1LM treatment. The primary endpoint is overall survival (OS). Additional follow-up and analysis are ongoing. Results: 595 patients were analyzed. At data cutoff (December 7, 2023), median follow-up was 26.3 months (range, 0.6–43.7); 125 patients (21.0%) remained on avelumab. Reasons for discontinuation were disease progression in 340 patients (72.5%), adverse event in 53 (11.3%), death in 44 (9.4%), and other reasons in 32 (6.8%). 330 patients (55.5%) received second-line treatment after avelumab: chemotherapy in 244 (73.9%), antibody–drug conjugate (ADC) in 62 (18.8%; including enfortumab vedotin, 56 [17.0%]). Characteristics of patients who received second-line ADC or chemotherapy were generally similar; most patients had received 1L carboplatin + gemcitabine (62.3 vs. 63.6%), and had an ECOG performance status of 0/1 (81.6 vs. 82.3%) and metastatic disease at start of 1L chemotherapy (96.8 vs. 95.0%). In the overall population, median OS from start of avelumab 1LM was 21.3 months (95% CI: 17.6–24.6), and 1- and 2-year OS rates (95% CI) were 66.52% (62.53–70.19%) and 45.89% (41.55–50.12%), respectively. In patients who received second-line ADC or chemotherapy, median OS (95% CI) from start of avelumab 1LM was 31.3 months (29.1–not estimable) and 14.4 months (13.2–15.9). Conclusion: Updated results from the AVENANCE study confirm the effectiveness of avelumab 1LM in a real-world population. In patients with second-line treatment (≈70% of patients who discontinued), a contemporary sequence of ADC after 1L platinum-based chemotherapy and avelumab 1LM treatment showed encouraging OS. ©2024 ASCO. Reused with permission. Presented at the 2024 Genitourinary Cancers Symposium. Funding Source: This trial was sponsored by Pfizer and was previously conducted under an alliance between Merck (CrossRef Funder ID: 10.13039/100009945) and Pfizer. This analysis was sponsored by Merck. Medical writing support was provided by Amy Davidson of Nucleus Global and was funded by Merck. Publication History Article published online: 20 February 2026 © 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/) Thieme Medical and Scientific Publishers Pvt. Ltd. A-12, 2nd Floor, Sector 2, Noida-201301 UP, India

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