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. 2025 Jul 16:S1078-1439(25)00208-X.
doi: 10.1016/j.urolonc.2025.05.014. Online ahead of print.

Early real-world utilization of avelumab switch maintenance among patients with advanced urothelial carcinoma without progression following treatment with first-line platinum-based chemotherapy

Helen H Moon  1 , Jeanny B Aragon-Ching  2 , Allison Thompson  3 , Anup Abraham  4 , Anna Vlahiotis  3 , Chiemeka Ike  5 , Darrin Benjumea  4 , Anran Shao  4 , Haiyan Sun  4 , Mairead Kearney  6 , Norbek Gharibian  3 , Sarah Hanson  3 , Benjamin Li  3 , Melissa Kirker  3 , Petros Grivas  7
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Free article

Early real-world utilization of avelumab switch maintenance among patients with advanced urothelial carcinoma without progression following treatment with first-line platinum-based chemotherapy

Helen H Moon et al. Urol Oncol. .
Free article

Abstract

Background: A standard treatment option for patients with locally advanced/metastatic urothelial carcinoma (la/mUC) is first-line platinum-based chemotherapy (1L PBC) followed by avelumab 1L switch maintenance (1LM) in patients without progression. This study aimed to evaluate the real-world treatment patterns and outcomes in patients with la/mUC in the US treated with 1L PBC and characterize the early adoption of avelumab 1LM following FDA approval in June 2020.

Methods: This retrospective cohort study identified adults diagnosed with la/mUC between January 2017 and September 2021 using electronic health records from the Flatiron Health database. Patients were grouped based on real-world response to 1L PBC: complete or partial response (rwCR/PR) or stable disease (rwSD). Baseline characteristics and treatment patterns were described. Clinical outcomes, including real-world overall survival (rwOS) and progression-free survival (rwPFS), were analyzed using the Kaplan-Meier method.

Results: Of 1,703 identified patients with la/mUC treated with 1L PBC, 1,245 (73%) had response data available during the study period, with 998 (80%) having a best response of rwCR/PR (60%) or rwSD (20%). Demographic and clinical characteristics were similar between patients with rwCR/PR and rwSD. Patients with rwCR/PR had longer median rwOS and rwPFS from 1L PBC initiation vs patients with rwSD. Of patients evaluated after FDA approval of avelumab 1LM on June 30, 2020, 435 discontinued 1L PBC. Of these patients, 339 had response data, and 138 of those without progression were considered avelumab 1LM eligible. Of these, 97 (70%) initiated avelumab 1LM within 180 days following last administration of 1L PBC, with 40 patients receiving second-line (2L) treatment, most commonly enfortumab vedotin (60%).

Conclusion: In the post-FDA approval period, uptake of avelumab 1LM was high (70%) in patients with rwSD or rwCR/PR following 1L PBC, and 41% of these patients received 2L treatment, most commonly with enfortumab vedotin.

Keywords: Avelumab first-line maintenance; Electronic health records; Locally advanced/metastatic urothelial carcinoma; Platinum-based chemotherapy; Real-world outcomes; Treatment patterns; Treatment sequencing.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: H.H. Moon has served in consulting or advisory roles for Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany; and has received funding for travel, accommodation, and expenses from Bayer. J.B. Aragon-Ching has served in consulting or advisory roles for Algeta/Bayer, Amgen, AstraZeneca, AstraZeneca/MedImmune, AVEO, Bayer, Dendreon, Exelixis, Immunomedics, Janssen Biotech, Merck & Co., Rahway, NJ, Pfizer, Pfizer/Myovant, Sanofi, Seagen, and the healthcare business of Merck KGaA, Darmstadt, Germany; reports speakers services for Astellas Pharma, Bristol Myers Squibb, Janssen-Ortho, and Seagen/Astellas Pharma; has received travel and accommodation expenses from Algeta/Bayer, Astellas Pharma, Bristol Myers Squibb, Dendreon, and the healthcare business of Merck KGaA, Darmstadt, Germany; and has received honoraria from Astellas Scientific and Medical Affairs Inc, Bristol Myers Squibb, Pfizer, and the healthcare business of Merck KGaA, Darmstadt, Germany. A. Thompson is an employee of Pfizer. A. Abraham, D. Benjumea, A. Shao, and H. Sund are employees of Genesis Research Group, which received consulting fees from Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany for this study. A. Vlahiotis is an employee of Pfizer. C. Ike is an employee of EMD Serono, Boston, MA, USA and has stock and other ownership interests in Merck KGaA, Darmstadt, Germany. M. Kearney is an employee of the healthcare business of Merck KGaA, Darmstadt, Germany and has stock and other ownership interests in Merck KGaA, Darmstadt, Germany, Novartis, and UCB. N. Gharibian, S. Hanson, B. Li, and M. Kirker are employees of Pfizer. P. Grivas has served in consulting or advisory roles for AADI, AbbVie, Asieris Pharmaceuticals, Astellas Pharma, AstraZeneca, BostonGene, Bristol Myers Squibb, CG Oncology, Fresenius Kabi, G1 Therapeutics, Gilead Sciences, lmmunityBio, Janssen, Lucence Health, Merck & Co., Rahway, NJ, Pfizer, PureTech, Roche, Seagen, Silverback Therapeutics, Strata Oncology, and the healthcare business of Merck KGaA, Darmstadt, Germany, and has received institutional research funding from Acrivon Therapeutics, ALX Oncology, Bristol Myers Squibb, G1 Therapeutics, Genentech, Gilead Sciences, GSK, Merck & Co., Rahway, NJ, Mirati Therapeutics, Pfizer, QED Therapeutics, and the healthcare business of Merck KGaA, Darmstadt, Germany.

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