First-Line Enfortumab Vedotin Plus Pembrolizumab vs Gemcitabine Plus Cisplatin for Metastatic Urothelial - Report - MDSpire

First-Line Enfortumab Vedotin Plus Pembrolizumab vs Gemcitabine Plus Cisplatin for Metastatic Urothelial

  • By

  • Eusebio Luna Velasquez

  • Renil S. Titus

  • David-Dan Nguyen

  • Carlos Riveros

  • Aly-Khan Lalani

  • Dharam Kaushik

  • Guru P. Sonpavde

  • Petros Grivas

  • Christopher J. D. Wallis

  • Raj Satkunasivam

  • July 1, 2026

  • 0 min

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Clinical Report: Comparison of First-Line Enfortumab Vedotin Combined with Pembrolizumab

Overview

This study evaluates the overall survival (OS) of patients with metastatic urothelial carcinoma (mUC) receiving first-line enfortumab vedotin plus pembrolizumab (EV/P) compared to gemcitabine and cisplatin (G/C).

Background

Metastatic urothelial carcinoma is associated with poor long-term survival, and traditional platinum-based chemotherapy has shown limited efficacy. The phase 3 EV-302 trial indicated that EV/P provides superior OS and progression-free survival compared to standard chemotherapy, leading to its FDA approval as a first-line treatment.

Data Highlights

This study utilized deidentified electronic health record data from the TriNetX database, including over 140 healthcare organizations. The primary outcome was overall survival (OS) from the initiation of therapy, with secondary outcomes including treatment sequencing patterns and adverse events.

Key Findings

  • EV/P demonstrated superior overall survival compared to G/C in a retrospective cohort of patients with mUC.
  • Patients receiving EV/P had a longer time to next treatment, indicating potential benefits in progression-free survival.
  • Subgroup analyses revealed variations in OS based on age, race, sex, and site of metastasis.
  • Adverse events were monitored, with a focus on treatment-related complications in both treatment groups.
  • The study adhered to the STROBE reporting guidelines for observational studies.

Clinical Implications

Observational data can help assess the effectiveness of EV/P in routine practice.

Conclusion

This retrospective analysis supports the use of EV/P as a first-line treatment option for mUC.

Related Resources & Content

  1. The ASCO Post, 2020 -- Enfortumab Vedotin Plus Pembrolizumab in Bladder Cancer
  2. The ASCO Post, 2025 -- Enfortumab Vedotin Plus Pembrolizumab Continues to Show Benefit in Metastatic Urothelial Carcinoma
  3. The ASCO Post, 2025 -- Enfortumab Vedotin–Based Approaches to Metastatic Urothelial Carcinoma
  4. ESMO Clinical Practice Guideline, 2024 -- Interim Update on First-Line Therapy in Advanced Urothelial Carcinoma
  5. FDA Approves Enfortumab Vedotin-ejfv With Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer, 2023
  6. Frontiers in Immunology — Real-World Safety of First-Line Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Carcinoma: Evidence from VigiBase and FAERS
  7. ESMO Clinical Practice Guideline interim update on first-line therapy in advanced urothelial carcinoma
  8. FDA Approves Enfortumab Vedotin-ejfv With Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer - The ASCO Post
  9. https://d1e9kxy1cpqb2c.cloudfront.net/media/201/NCCN_Bladder_Cancer_Guidelines_2024.pdf
  10. 1 Recommendation | Enfortumab vedotin with pembrolizumab for untreated unresectable or metastatic urothelial cancer when platinum-based chemotherapy is suitable | Guidance | NICE
  11. Nivolumab plus Gemcitabine–Cisplatin in Advanced Urothelial Carcinoma | New England Journal of Medicine
  12. FDA approves avelumab for urothelial carcinoma maintenance treatment | FDA

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