Mapping Progress in Bladder Cancer

For those of us who take care of patients with the sixth most common malignancy in the United States and the seventh most common cause of cancer-related death,it was disheartening that, as recently as 2015, patients with advanced bladder cancer had no effective alternatives to cisplatinum-based chemotherapy, a status quo that had persisted for three decades.2

Adding to this, patients who had tumors that did not respond to BCG therapy also had no true alternative other than radical cystectomy.3

Over the last 2 years, we have seen rapid progress in the bladder cancer arena, with an explosion of clinical trials across all disease states. Five PD-1 and PD-L1 checkpoint inhibitors are now FDA-approved for the treatment of metastatic urothelial cancer, while a fibroblast growth factor receptor (FGFR) inhibitor and an antibody-drug conjugate each have received breakthrough designation status.4-10 Soon, results from additional registration trials are expected to further expand our options for treating both early-stage and advanced disease. This rapidly evolving landscape is incredibly exciting, but also creates a challenge as busy physicians struggle to keep track of numerous pivotal studies that have or will read out over such a compressed timeframe.

1 Regulatory Approval Timeline advanced bladder therapies V3

1 Regulatory Approval Timeline advanced bladder therapies V3
1 Regulatory Approval Timeline advanced bladder therapies V3

The figures and summary by Noah Hahn, MD, are an invaluable map of these trials and resulting approvals.11 I thank Noah for collating these many trials and presenting them in such a clear and updatable manner. Any investigator whose bladder cancer trial is not shown in the figures and who would like their trial included is invited to email UroToday at . We welcome your additions and feedback.

Download Accompanying Figures

Published Date: July 12th, 2019

Written by: Ashish Kamat, MD, MBBS
  1. National Cancer Institute. Cancer Stat Facts: Bladder Cancer. Accessed January 15, 2019.
  2. Hermans TJN, Voskuilen CS, van der Heijden MS, et al. Neoadjuvant treatment for muscle-invasive bladder cancer: The past, the present, and the future. Urol Oncol 2018 Sep;36(9):413-422.
  3. Kamat AM et al. BCG-unresponsive non-muscle-invasive bladder cancer: recommendations from the IBCG. Nat Rev Urol. 2017 Apr;14(4):244-255.
  4. Bellmunt J, de Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med 2017 Mar;376(11):1015-1026.
  5. Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol 2018 Jan;19(1):51-64.
  6. Powles T, O'Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: Updated results from a phase 1/2 open-label study. JAMA Oncol 2017;3(9):e172411.
  7. Rosenberg JE, Hoffman-Censits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet 2016 May 7;387(10031):1909-1920.
  8. Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. TLancet Oncol 2017 Mar;18(3):312-322.
  9. Rosenberg JE, Sridhar SS, Zhang J, et al. Updated results from the enfortumab vedotin phase 1 (EV-101) study in patients with metastatic urothelial cancer (mUC). J Clin Oncol 2018 May;36(15_suppl):4504-4504.
  10. Siefker-Radtke AO, Necchi A, Park SH, et al. First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). J Clin Oncol 2018 May;36(15_suppl):4503-4503.
  11. Hahn, NM. A Golden Age of Bladder Cancer Drug Development.
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