Overlapping Extremes: An Analysis of Avelumab Maintenance and Pembrolizumab in Advanced Urothelial Carcinoma.

IF 3.4 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2025-12-01 Epub Date: 2025-10-15 DOI:10.1007/s40487-025-00387-7

Martina Catalano, Irene de Gennaro Aquino, Ismaela Anna Vascotto, Adriana Guarino, Silvia Mancini, Laura Doni, Alexandra Paulet, Virginia Rossi, Roberta Giorgione, Gabriella Nesi, Lorenzo Antonuzzo, Giandomenico Roviello

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Abstract

Introduction: Avelumab and pembrolizumab are approved immune checkpoint inhibitors (ICIs) for advanced urothelial carcinoma (UC) that are used as maintenance and salvage therapies, respectively. The aim of this study was to highlight patterns of extreme response and support the development of biomarker-driven strategies to optimise patient selection and treatment sequencing.

Methods: This was a prospective study that included 79 patients with advanced UC treated with avelumab (n = 32) or pembrolizumab (n = 47) following platinum-based chemotherapy. Outcomes included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).

Results: Avelumab was associated with a DCR of 84.4% and a complete response (CR) rate of 34.4%, while pembrolizumab was associated with a DCR of 55.3% and a CR rate of 12.8%. Progressive disease (PD) occurred in 15.6% and 44.7% of patients, respectively. Despite differences in treatment indications and timing, median PFS and OS in patients with CR and PD were surprisingly comparable across the two agents.

Conclusions: These findings suggest that extreme responses to ICIs in advanced UC-ranging from complete response to primary progression-may occur irrespective of treatment setting, underscoring the pivotal role of tumour-immune biology. Biomarker-driven strategies are needed to optimise patient selection.

Trial registration: OBSERVE-UC study; registration ID: CEAVC 25351.

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重叠极端：晚期尿路上皮癌中Avelumab维持和Pembrolizumab的分析。

Avelumab和pembrolizumab是被批准用于晚期尿路上皮癌（UC）的免疫检查点抑制剂（ICIs），分别用于维持和挽救治疗。这项研究的目的是强调极端反应的模式，并支持生物标志物驱动策略的发展，以优化患者选择和治疗测序。方法：这是一项前瞻性研究，纳入了79例晚期UC患者，在铂基化疗后接受avelumab （n = 32）或pembrolizumab （n = 47）治疗。结果包括客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）和总生存期（OS）。结果：Avelumab的DCR为84.4%，完全缓解（CR）率为34.4%，而pembrolizumab的DCR为55.3%，CR率为12.8%。进行性疾病（PD）发生率分别为15.6%和44.7%。尽管在治疗适应症和时间上存在差异，但CR和PD患者的中位PFS和OS在两种药物中具有惊人的可比性。结论：这些发现表明，无论治疗环境如何，晚期uc患者对ICIs的极端反应（从完全缓解到原发性进展）都可能发生，强调了肿瘤免疫生物学的关键作用。需要生物标志物驱动的策略来优化患者选择。试验注册：OBSERVE-UC研究；注册ID: CEAVC 25351。

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来源期刊

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. 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For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors'' or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Please see here for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. 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