UNMET NEED
IN LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA (UC),

First-Line Platinum-Containing Chemotherapy: A Proven Approach to Disease Control1,2

Platinum-containing chemotherapy effectively controls tumor growth in the first-line setting3,4

  • Appropriate for ~80% of patients who are being treated for locally advanced or metastatic UC4,5
  • Evolution in eligibility guidelines has resulted in an established approach2,6

~50% of patients receiving treatment for locally advanced or metastatic UC are eligible for cisplatin-based chemotherapy2,6

Carboplatin-based chemotherapy is a demonstrated option for cisplatin-ineligible patients2,7

In randomized trials in patients with locally advanced or metastatic UC who received any first-line platinum-containing chemotherapy,

~3 IN 4 PATIENTS

achieved disease control8-10

Subsequent first-line maintenance treatment with immunotherapy may result in sustained antitumor activity, extending the overall survival benefit.11

NATIONAL COMPREHENSIVE CANCER NETWORK® (NCCN®) RECOMMENDATION
NCCN-logo

NCCN Recommendation

Avelumab (BAVENCIO) maintenance is the only NCCN CATEGORY 1 and PREFERRED immunotherapy option for both cisplatin-eligible and -ineligible patients with locally advanced or metastatic urothelial carcinoma that has not progressed on first-line platinum-containing chemotherapy.1

Category 1=Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Preferred intervention=Interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability. 

 


NCCN preferred regimens for first-line systemic therapy for locally advanced or metastatic urothelial carcinoma1

NCCN preferred regimens for first-line systemic therapy for locally advanced or metastatic urothelial carcinoma
NCCN preferred regimens for first-line systemic therapy for locally advanced or metastatic urothelial carcinoma

Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.

*Statement from EMD Serono: The avelumab registrational study for this indication did not specifically investigate maintenance therapy following DDMVAC with growth factor support.

aMaintenance therapy with avelumab only if there is no progression on first-line platinum-containing chemotherapy.

DDMVAC=dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin.

1L CHEMOTHERAPY GUIDELINES

Explore the criteria for platinum-based chemotherapy in metastatic urothelial carcinoma (UC).

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438. doi:10.1200/JCO.2011.34.8433 3. Fisher MD, Shenolikar R, Miller PJ, Fenton M, Walker MS. Treatment patterns and outcomes in stage IV bladder cancer in a community oncology setting: 2008-2015. Clin Genitourin Cancer. 2018;16(6):e1171-e1179. doi:10.1016/j.clgc.2018.07.025 4. Niegisch G, Gerullis H, Lin SW, et al. A real-world data study to evaluate treatment patterns, clinical characteristics and survival outcomes for first- and second-line treatment in locally advanced and metastatic urothelial cancer patients in Germany. J Cancer. 2018;9(8):1337-1348. doi:10.7150/jca.23162 5. Bamias A, Tzannis K, Harshman LC, et al. Impact of contemporary patterns of chemotherapy utilization on survival in patients with advanced cancer of the urinary tract: a Retrospective International Study of Invasive/Advanced Cancer of the Urothelium (RISC). Ann Oncol. 2018;29(2):361-369. doi:10.1093/annonc/mdx692 6. Cathomas R, Lorch A, Bruins HM, et al. The 2021 updated European Association of Urology guidelines on metastatic urothelial carcinoma. Eur Urol. 2022;81(1):95-103. doi:10.1016/j.eururo.2021.09.026 7. Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383(13):1218-1230. doi:10.1056/NEJMoa2002788 8. von der Maase H, Hansen SW, Roberts JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000;18(17):3068-3077. doi:10.1200/JCO.2000.18.17.3068 9. de Santis M, Bellmunt J, Mead G, et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC Study 30986. J Clin Oncol. 2012;30(2):191-199. doi:10.1200/JCO.2011.37.3571 10. Bellmunt J, von der Maase H, Mead GM, et al. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC Intergroup Study 30987. J Clin Oncol. 2012;30(10):1107-1113. doi:10.1200/JCO.2011.38.6979 11. Grivas P, Monk B, Petrylak D, et al. Immune checkpoint inhibitors as switch or continuation maintenance therapy in solid tumors: rationale and current state. Target Oncol. 2019;14(5):505-525. doi:10.1007/s11523-019-00665-1