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Real-world effectiveness of avelumab, pembrolizumab, and enfortumab vedotin in patients with advanced urothelial carcinoma with squamous differentiation (ARON-2EV)
(Springer Science and Business Media LLC, 2026)
Mollica, Veronica
;
Massari, Francesco
;
Fujita, Kazutoshi
;
Giannatempo, Patrizia
;
Grande, Enrique
Introduction: Avelumab, pembrolizumab, and enfortumab vedotin (EV) demonstrated efficacy in mUC following platinum-based chemotherapy. However, real-world data in patients with urothelial carcinoma with squamous differentiation (UCSD) are limited. The aim of this study is to assess the real-world clinical outcomes of avelumab, pembrolizumab, or EV in mUCSD patients. Materials and methods: The ARON-2EV study is a retrospective, international, multicenter analysis in patients with mUC treated with avelumab, pembrolizumab, or EV across 79 centers in 21 countries. Patients were divided into three cohorts: 1 (avelumab), 2 (pembrolizumab), and 3 (EV). Primary endpoints were overall survival (OS) and time on treatment (ToT). Secondary objectives included evaluating clinical factors associated with outcomes and exploring the impact of UCSD histology on response to therapy. Statistical methods included Kaplan–Meier estimates, log-rank tests, Fisher’s exact and chi-square tests, and Pearson’s correlation coefficients. Results: A total of 1918 patients, 1696 with advanced pure UC (pUC) and 222 with mUCSD (36 in cohort 1, 111 in cohort 2, and 75 in cohort 3), were included. Median OS was shorter in patients with UCSD compared to patients with pUC histology in the three cohorts (1: 13.0 vs 26.8 months, HR 2.66, p = 0.003; 2: 10.2 vs 18.5 months, HR 1.52, p = 0.008; and 3: 7.6 vs 13.1 months, HR 1.68, p = 0.011). Median ToT was shorter in patients with UCSD compared to patients with pUC histology in cohort 1 (3.5 vs 5.6 months, HR 1.57, p = 0.044) and 3 (7.6 vs 13.6 months, HR 1.83, p = 0.005) but not in cohort 2 (3.7 vs 4.7 months, HR 1.19, p = 0.177). Response to therapy was negatively correlated with UCSD histology in cohorts 2 (correlation coefficient 0.094, p = 0.008) and 3 (correlation coefficient 0.107, p = 0.021), while response to avelumab was not correlated with UCSD (correlation coefficient 0.072, p = 0.263). Conclusions: UCSD is a histology with a poor prognosis and response to treatments compared to pUC. Treatments activity and effectiveness in divergent differentiations should be addressed in dedicated prospective studies. ©The authors ©Springer.
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Geographical Differences in the Management and Outcomes of Patients With Advanced Urothelial Carcinoma Treated With Pembrolizumab After Progression on Platinum-Based Chemotherapy: Results From ARON-2 Study
(Lippincott Williams and Wilkins, 2025-07-01)
Rizzo, Mimma
;
Soares, Andrey
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Gupta, Shilpa
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Calabrò, Fabio
;
Takeshita, Hideki
Purpose: Our investigation assessed the impact of geographical disparities in the treatment of patients with advanced urothelial cancer (aUC) included in the international, real-world ARON-2 trial. Patients and Methods: The study population comprised 1,137 patients with aUC treated with pembrolizumab for relapsed or progressive disease after platinum-based chemotherapy (PBC) at 63 institutions in 19 countries. Patients were divided into three geographical areas: Europe (area 1: 791 patients), the United States (area 2: 156 patients), and Asia (area 3: 190 patients). Clinicopathologic and treatment data were extracted from medical records. The primary end points were to identify differences in patient and treatment characteristics and to assess overall survival (OS) and progression-free survival (PFS) between the three areas. Results: There were differences in patient characteristics: more patients age 70 years and older in area 1; more patients with BMI ≥25 kg/m2, squamous histotype, and T1 neoplasia at diagnosis in area 2; and more pure urothelial carcinoma in area 3. There were differences in treatment characteristics: Bacillus Calmette-Guérin instillations and primary tumor surgery were more common in area 1; neoadjuvant and adjuvant PBC, third-line therapies, and specifically enfortumab vedotin (EV) were less common in area 1. Median OS (mOS) from pembrolizumab initiation was 13.0 months in area 1, 29.1 months in area 2 and 13.2 months in area 3 (P < .001), and median PFS was 4.8 months, 5.2 months, and 3.8 months, respectively (P = .002). In patients receiving EV after progression to PBC and pembrolizumab, mOS was 44.1 months in area 1, 31.7 months in area 2, and 23.8 months in area 3 (P = .267). Conclusion: Real-world data suggest that facilitating and extending access to targeted therapies for patients with aUC in different geographical areas worldwide may lead to a consistent and widespread survival increase. ©The authors ©JCO Global Oncology ©Lippincott Williams and Wilkins.
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Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience
(Wiley, 2025)
Rizzo, Mimma
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Morelli, Franco
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Ürün, Yüksel
;
Buti, Sebastiano
;
Park, Se Hoon
Background: Recently, a plethora of novel systemic agents have been incorporated into the therapeutic armamentarium of advanced urothelial carcinoma (aUC). The antibody–drug conjugate (ADC), enfortumab vedotin (EV), has demonstrated relevant clinical benefit in patients with aUC refractory to platinum and immune-checkpoint inhibitor (ICI) therapy. Our study provides a retrospective, international, real-world analysis comparing the effectiveness of EV to chemotherapy in this setting. Methods: The data were extracted from the medical records of patients treated with EV or chemotherapy following pembrolizumab for recurrent or progressive aUC after platinum-based chemotherapy. Patients were assessed for overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR). Results: Our analysis included 247 patients treated with EV (88, 36%) or chemotherapy (159, 64%). Median OS was 9.1 months (95%CI 7.2–10.7) in the overall study population, 13.6 months (95%CI 10.0–31.0) in patients receiving EV and 6.8 months (95%CI 6.0–8.9) in patients receiving chemotherapy (p < 0.001). The OS benefit of EV was not affected by primary tumour site and histology, metastatic sites, type of first platinum-based chemotherapy or response to pembrolizumab. In the EV cohort, the median PFS was significantly longer (8.8 months [95%CI 6.5–17.0] vs. 3.0 months [95%CI 2.6–3.7]) and the ORR was significantly higher (56% vs. 23%) than in the chemotherapy cohort. ©The authors ©Wiley ©Cancer Medicine.

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