Bavencio - Safety

Avelumab 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 (UC) that has not progressed on first-line platinum-containing chemotherapy.³

Category 1=Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

NCCN=National Comprehensive Cancer Network^® (NCCN^®)

Preferred intervention=Interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability.

1. 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 2. Galsky M, Balar A, Black P, et al. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer. J Immunother Cancer. 2021;9:e002552. doi:10.1136/jitc-2021-002552 3. 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 May 25, 2023. 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. 4. 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. 5. Bavencio. Prescribing Information. EMD Serono, Inc.; 2023. 6. Grivas P, Park SH, Voog E, et al. Avelumab first-line maintenance therapy for advanced urothelial carcinoma: comprehensive clinical subgroup analyses from the JAVELIN Bladder 100 Phase 3 Trial. Eur Urol. 2023;84(1):95-108. 7. Powles T, Park SH, Caserta C, et al. Avelumab first-line maintenance for advanced urothelial carcinoma: results from the JAVELIN Bladder 100 Trial after ≥2 years of follow-up. J Clin Oncol. 2023;41(19):3486-3492. 8. Data on file. EMD Serono, Inc., Rockland, MA. 9. US Food and Drug Administration. FDA approves avelumab for urothelial carcinoma maintenance treatment. News release. June 30, 2020. Accessed December 20, 2022. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approvesavelumab-urothelial-carcinoma-maintenance-treatment 10. US Food and Drug Administration. FDA approves nivolumab for adjuvant treatment of urothelial carcinoma. News release. August 19, 2021. Accessed December 20, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma 11. Bajorin D, Witjes J, Gschwend J, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384:2102-2014. doi:10.1056/NEJMoa2034442.

Safety

Laboratory abnormalities⁵

Primary analysis, data cutoff October 21, 2019⁴

Selected laboratory abnormalities worsening from baseline occurring in ≥10% of patients receiving BAVENCIO + BSC

Laboratory abnormalities5

Primary analysis, data cutoff October 21, 20194

Selected laboratory abnormalities worsening from baseline occurring in ≥10% of patients receiving BAVENCIO + BSC

Laboratory abnormalities⁵

Primary analysis, data cutoff October 21, 2019⁴