You are about to leave this site and are being redirected to another site. Would you like to leave this site?

UNMET NEED

In the first-line treatment of eligible patients with locally advanced or metastatic urothelial carcinoma (UC), platinum-containing chemotherapy followed by best supportive care (BSC)* has been a standard of care—however, an unmet medical need remains1

First-line platinum-containing chemotherapy followed by BSC

chart
chart
1L-uc-maintenance

Tap to zoom in

~9 to 15 months median overall survival range for patients treated with first-line platinum-containing chemotherapy followed by BSC9‡


First-line maintenance treatment with BAVENCIO® (avelumab) was investigated to determine whether it could prolong overall survival vs BSC alone in patients who did not progress on first-line platinum-containing chemotherapy9

first-line-maintanence
first-line-maintanence
1L-uc-maintenance-2

Tap to zoom in

 

*BSC excludes systemic antitumor therapy.9

Platinum-containing therapy in first-line treatment includes gemcitabine + cisplatin, gemcitabine + carboplatin, and a dose-dense combination of methotrexate, vinblastine, doxorubicin, and cisplatin with growth factor support.11

14-15 months mOS for patients treated with cisplatin-containing regimens and 9-10 months mOS for patients treated with carboplatin-containing regimens.9

CR=complete response; PR=partial response; SD=stable disease.

CONSIDER BAVENCIO

BAVENCIO® (avelumab)–the ONLY immunotherapy approved for the first-line maintenance treatment of locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy

tick-mark-icon

Only immunotherapy FDA-approved for first-line maintenance treatment of urothelial carcinoma

tick-mark-icon

Overall survival benefit demonstrated in Phase 3 randomized trial

tick-mark-icon

A treatment option regardless of cisplatin-eligibility 

tick-mark-icon

A treatment option regardless of PD-L1 status

NCCN RECOMMENDATION

image-1

National Comprehensive Cancer Network® (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 UC that has not progressed on first-line platinum-containing chemotherapy.11

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 Carcinoma12

charts-for-cisplatin

image-1

 

Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.4.2021. © 2021 National Comprehensive Cancer Network, Inc. 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 and Pfizer: The avelumab registrational study for this indication did not specifically investigate avelumab maintenance therapy following DDMVAC with growth factor support.

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

bAtezolizumab: SP142 assay, PD-L1-stained tumor-infiltrating immune cells covering ≥5% of the tumor area.

cPembrolizumab: 22C3 antibody assay, Combined Positive Score (CPS) ≥10.

CTCAE=Common Terminology Criteria for Adverse Events; DDMVAC=dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin; ECOG=Eastern Cooperative Oncology Group; NYHA=New York Heart Association; PD-L1=programmed death ligand-1; PS=performance status; WHO=World Health Organization.

Proposed Criteria to Define Patients Unfit for Cisplatin-Based Chemotherapy from Galsky MD, et al. J Clin Oncol. 201113

Presence of at least one of the following:
  • WHO or ECOG PS of 2, or Karnofsky PS of 60% to 70%
  • Creatinine clearance <60 mL/min
  • CTCAE v4 Grade ≥2 audiometric hearing loss
  • CTCAE v4 Grade ≥2 peripheral neuropathy
  • NYHA Class III heart failure

JAVELIN Bladder 100 study design

 

Efficacy

 

References: 1. Guancial EA, Chowdhury D, Rosenberg JE. Personalized therapy for urothelial cancer: review of the clinical evidence. Clin Investig (Lond). 2011;1(4):546-555. 2. Cheeseman S, Thompson M, Sopwith W, et al. Current treatment and outcomes benchmark for locally advanced or metastatic urothelial cancer from a large UK-based single centre. Front Oncol. 2020;10(167). doi:10.3389/fonc.2020.00167. 3. Galsky MD, Pal SK, Lin SW, et al. Real-world effectiveness of chemotherapy in elderly patients with metastatic bladder cancer in the United States. Bladder Cancer. 2018;4(2):227-238. 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. 5. Fisher M, Shenolikar R, Miller PJ, et al. Treatment patterns and outcomes in stage IV bladder cancer in a community oncology setting: 2008-2015. Clin Genitourin Cancer. 2018;16(6):e1171-e1179. 6. 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. 7. von der Maase H, Sengelov L, Roberts JT, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23(21):4602-4608. 8. 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. 9. 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. 10. Aly A, Johnson C, Yang S, Botteman MF, Rao S, Hussain A. Overall survival, costs, and healthcare resource use by line of therapy in Medicare patients with newly diagnosed metastatic urothelial carcinoma. J Med Econ. 2019;22(7):662-670. 11. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.4.2021. © National Comprehensive Cancer Network, Inc. 2021. 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. All rights reserved. Accessed September 2, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. 12. Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.4.2021. © National Comprehensive Cancer Network, Inc. 2021. 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. 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. 13. 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.