EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin vs chemotherapy in patients with previously treated advanced urothelial carcinoma

Fecha de publicación: Fecha Ahead of Print:

Autores de IDIVAL

Autores ajenos al IDIVAL

  • Rosenberg JE
  • Powles T
  • Sonpavde GP
  • Loriot Y
  • Lee JL
  • Matsubara N
  • Vulsteke C
  • Castellano D
  • Mamtani R
  • Wu C
  • Matsangou M
  • Campbell M
  • Petrylak DP



INTRODUCTION: This exploratory analysis evaluated efficacy and safety data for enfortumab vedotin versus chemotherapy over median follow-up of approximately 2 years from EV-301. MATERIALS AND METHODS: Patients with locally advanced/metastatic urothelial carcinoma with prior platinum-containing chemotherapy and disease progression during/after programmed cell death protein 1/ligand 1 inhibitor treatment were randomized to enfortumab vedotin or chemotherapy (docetaxel, paclitaxel, vinflunine). Endpoints were overall survival (primary), progression-free survival (PFS), objective response, and safety. RESULTS: In total, 608 patients were included (enfortumab vedotin, n = 301; chemotherapy, n = 307). With median follow-up of 23.75 months, 444 deaths had occurred (enfortumab vedotin, n = 207; chemotherapy, n = 237). Risk of death was reduced by 30% with enfortumab vedotin versus chemotherapy (HR 0.70 [95% CI, 0.58 to 0.85]; 1-sided, log-rank P = 0.00015); PFS improved with enfortumab vedotin (HR 0.63 [95% CI, 0.53 to 0.76]; 1-sided, log-rank P < 0.00001). Treatment-related adverse event rates were 93.9% for enfortumab vedotin and 91.8% for chemotherapy; grade = 3 event rates were 52.4% and 50.5%, respectively. Grade = 3 treatment-related decreased neutrophil count (14.1% vs 6.1%), decreased white blood cell count (7.2% vs 1.4%), and anemia (7.9% vs 2.7%) were more common with chemotherapy versus enfortumab vedotin; maculopapular rash (7.4% vs 0%), fatigue (6.8% vs 4.5%), and peripheral sensory neuropathy (5.1% vs 2.1%) were more common with enfortumab vedotin. Of special interest adverse events, treatment-related skin reactions occurred in 47.3% of patients receiving enfortumab vedotin and 15.8% of patients receiving chemotherapy; peripheral neuropathy occurred in 48.0% versus 31.6%, respectively, and hyperglycemia in 6.8% versus 0.3%. CONCLUSIONS: After median follow-up of approximately 2 years, enfortumab vedotin maintained clinically meaningful overall survival benefit versus chemotherapy, consistent with findings from the EV-301 primary analysis; PFS and overall response benefit remained consistent. Adverse events were manageable; no new safety signals were observed.

Copyright © 2023. Published by Elsevier Ltd.

Datos de la publicación

0923-7534, 1569-8041



Citas Recibidas en Web of Science: 2


  • No hay documentos


Filiaciones mostrar / ocultar


  • Urinary bladder neoplasms; antibody–drug conjugate; long-term survival follow-up