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<p>Enfortumab vedotin (EV) is an antibody–drug conjugate targeting Nectin-4 and is approved for patients with advanced urothelial carcinoma (UC) who have progressed after platinum-based chemotherapy and immune checkpoint inhibitors. While clinical trials have demonstrated manageable safety profiles, real-world toxicity data remain limited. We conducted a multi-center retrospective study of consecutive patients with locally advanced or metastatic UC treated with EV between January 2022 and April 2025. Demographic, clinical, and treatment-related data were extracted from electronic medical records. Primary endpoints included incidence of G3-G4 AEs, dose reductions, and discontinuations. A total of 770 patients were included; 195 patients (25%) reported G3-G4 AEs. The most common G3-G4 AEs were dermatologic (10%), neuropathy (9%) and diarrhea (7%). Seventy-four patients (10%) discontinued EV due to G3-G4 AEs. Both the median OS (21.3&#xa0;months vs 16.1&#xa0;months, <i>p</i> = 0.010) and PFS (8.2&#xa0;months vs 6.8&#xa0;months, <i>p</i> = 0.012) were significantly longer in patients who started EV therapy at standard dose versus at reduced dose. In conclusion, this real-world cohort showed that EV demonstrated a toxicity profile broadly consistent with clinical trial data, though rates of dose modification were substantial. Enhanced monitoring and early toxicity management may optimize treatment continuity in advanced UC patients.</p>

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Real-world incidence of G3-G4 adverse events with enfortumab vedotin in patients with advanced urothelial carcinoma (ARON-2EV study)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月29日

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  • Patrizia Giannatempo,
  • Shilpa Gupta,
  • Mimma Rizzo,
  • Karl Mayrhofer,
  • Renate Pichler,
  • Dora Niedersuess-Beke,
  • Ondrej Fiala,
  • Javier Molina-Cerrillo,
  • Marc R. Matrana,
  • Randi Kinhel,
  • Luca Galli,
  • Alessia Salfi,
  • Tomas Buchler,
  • Alina Pirshtuk,
  • Jawaher Ansari,
  • Anca Zgura,
  • Ray Manneh Kopp,
  • Giandomenico Roviello,
  • Jindrich Kopecky,
  • Kirstin Binz,
  • Akihiro Yano,
  • Martin Angel,
  • Se Hoon Park,
  • Ravindran Kanesvaran,
  • Zin W. Myint,
  • Yüksel Ürün,
  • Francesco Massari,
  • Fernando Sabino Marques Monteiro,
  • Kannan Sridharan,
  • Matteo Santoni

摘要

Enfortumab vedotin (EV) is an antibody–drug conjugate targeting Nectin-4 and is approved for patients with advanced urothelial carcinoma (UC) who have progressed after platinum-based chemotherapy and immune checkpoint inhibitors. While clinical trials have demonstrated manageable safety profiles, real-world toxicity data remain limited. We conducted a multi-center retrospective study of consecutive patients with locally advanced or metastatic UC treated with EV between January 2022 and April 2025. Demographic, clinical, and treatment-related data were extracted from electronic medical records. Primary endpoints included incidence of G3-G4 AEs, dose reductions, and discontinuations. A total of 770 patients were included; 195 patients (25%) reported G3-G4 AEs. The most common G3-G4 AEs were dermatologic (10%), neuropathy (9%) and diarrhea (7%). Seventy-four patients (10%) discontinued EV due to G3-G4 AEs. Both the median OS (21.3 months vs 16.1 months, p = 0.010) and PFS (8.2 months vs 6.8 months, p = 0.012) were significantly longer in patients who started EV therapy at standard dose versus at reduced dose. In conclusion, this real-world cohort showed that EV demonstrated a toxicity profile broadly consistent with clinical trial data, though rates of dose modification were substantial. Enhanced monitoring and early toxicity management may optimize treatment continuity in advanced UC patients.