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For advanced urothelial cancer

Unmet need

Patients with unresectable or metastatic UC may only get one opportunity for systemic treatment3,4

More than half of patients who start 1L systemic therapy for metastatic UC do not receive a subsequent line of treatment5-8*

Graphic: Unmet need 57% of 1L treated patients will not recieve 2L
Unmet need 57% of 1L treated patients will not recieve 2L
  • *Most commonly due to early progression or decline in performance status.5,8

At the start of treatment, it is not possible to predict which patients will respond to therapy8,9

60% of patient can loos their opportunity
Graphic: Unmet need 60% of chemo treated patients are ineligile for maintenance immunotherapy

†Mainly because of disease progression, declining performance status, treatment-related toxicity, access barriers, or patient decision.8

1L treatment choice is crucial for maximising patient outcomes3,4,11

1L – first-line; 2L – second line; MoA – mechanism of action; UC – urothelial cancer

References

  1. PADCEV India prescribing information.
  2. Powles TB, van der Heijden MS, Loriot Y, et al. Enfortumab vedotin plus pembrolizumab in untreated locally advanced or metastatic urothelial carcinoma: 2.5-year median follow-up of the phase III EV-302/KEYNOTE-A39 trial. Ann Oncol 2025;36(10):1212-19.
  3. Alimohamed N, Grewal S, Wirtz HS, et al. Understanding treatment patterns and outcomes among patients with de novo unresectable locally advanced or metastatic urothelial cancer: a population-level retrospective analysis from Alberta, Canada. Curr Oncol 2022;29(10):7587-97.
  4. Morgans AK, Galsky MD, Wright P, et al. Real-world treatment patterns and clinical outcomes with first-line therapy in patients with locally advanced/metastatic urothelial carcinoma by cisplatin-eligibility. Urol Oncol 2023;41(8):357.e11-21.
  5. Moinard-Butot F, Barbe-Richaud J, Baudry E, Amrane K, Maillet D, Barthelemy P. Treatment sequence (TS) and overall survival (OS) in patients with metastatic urothelial cancer (mUC): an observational, multicenter, real-life STATES-Bladder study. Poster presented at: 2025 ASCO Genitourinary Cancers Symposium; 13-15 February 2025; San Francisco, CA, USA. Poster #724.
  6. Fernández Rodríguez R, Sagastibeltza N, Pujol Obis E, et al. EBANO study: real-world data from patients with locally advanced/metastatic urothelial carcinoma (la/mUC) in Northern Spain. ESMO Real World Data Digit Oncol 2024;6:100063.
  7. Joly F, Rouprêt M, Culine S, et al. Epidemiology and treatment patterns of patients with locally advanced or metastatic urothelial cancer in France: A non-interventional database study. Poster presented at: European Society for Medical Oncology Annual Meeting, 13-17 September 2024; Barcelona, Spain. Poster #2001.
  8. Sotelo M, Pelaez M, Basterretxea L, et al. Avelumab maintenance in advanced urothelial carcinoma: real-world data from Northern Spain (AVEBLADDER study). Clin Transl Oncol 2025;27(12):4481-92.
  9. Morgans AK, Sonpavde GP, Shih V, et al. Real-world treatment patterns and clinical outcomes in patients with locally advanced or metastatic urothelial carcinoma by eligibility for maintenance avelumab. Clin Genitourin Cancer 2025;23(1):102270.
  10. Li H, Herms L, Leong T, et al. US real-world first-line (1L) treatment patterns and outcomes for patients with metastatic urothelial carcinoma (mUC) following maintenance avelumab approval. Poster presented at: 2023 ASCO Genitourinary Cancers Symposium; 16-18 February 2025; San Fransico, CA, USA. Poster #483.
  11. Mamtani R, Matsubara N, Pino AM, et al. Outcomes by retrospective eligibility for maintenance therapy of patients with advanced urothelial carcinoma: post hoc analysis of the phase 3 KEYNOTE-361 trial. Clin Genitourin Cancer 2025;23(1):102248.

Efficacy outcomes

Review efficacy outcomes in 1L unresectable or metastatic UC

Safety outcomes


See safety results for 1L unresectable or metastatic UC

Resources and treatment support

Access resources to help navigate treatment with confidence

PADCEV, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. 

 

PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

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