Bavencio - Study Design

Study Design

JAVELIN Bladder 100 Trial was a Phase 3, 1:1 randomized, open-label, multicenter study of BAVENCIO^® (avelumab) as a first-line maintenance treatment in 700 patients with unresectable, locally advanced, or metastatic UC that did not progress with first-line platinum-containing chemotherapy.

BSC was administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, and other patient management approaches with palliative intent (excludes systemic antitumor therapy).⁴

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PD-L1 expression was assessed in tumor samples using the VENTANA PD-L1 (SP263) assay.⁴

CR=complete response; PD-L1=programmed death ligand-1; PR=partial response; SD=stable disease.

Stratified by best response to chemotherapy (CR/PR vs SD per RECIST V1.1) and site of metastasis (visceral vs non-visceral [including bone metastasis]) assessed at the time of initiating first-line platinum-containing chemotherapy⁴

Administration of BAVENCIO was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator

Assessment of tumor status was performed at baseline , 8 weeks after randomization, then every 8 weeks up to 12 months after randomization, and every 12 weeks thereafter until documented confirmed disease progression based on BICR assessment or RECIST v1.1.

BICR=blinded independent central review; CR=complete response; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease.

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.

JAVELIN Bladder 100 Trial was a Phase 3, 1:1 randomized, open-label, multicenter study of BAVENCIO® (avelumab) as a first-line maintenance treatment in 700 patients with unresectable, locally advanced, or metastatic UC that did not progress with first-line platinum-containing chemotherapy.

JAVELIN Bladder 100 Trial was a Phase 3, 1:1 randomized, open-label, multicenter study of BAVENCIO^® (avelumab) as a first-line maintenance treatment in 700 patients with unresectable, locally advanced, or metastatic UC that did not progress with first-line platinum-containing chemotherapy.