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STUDY DESIGN

JAVELIN Bladder 100 Trial–a Phase 3, randomized, open-label, multicenter study in patients with unresectable, locally advanced or metastatic urothelial carcinoma (UC) that did not progress with first-line platinum-containing chemotherapy (N=700)1

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  • 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 time of initiating first-line induction chemotherapy1
  • 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
  • Tumors were assessed at 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 per RECIST v1.1

 

*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).1

PD-L1 expression was assessed in tumor samples using the VENTANA PD-L1 (SP263) assay.1

BICR=blinded independent central review; CR=complete response; ECOG PS=Eastern Cooperative Oncology Group (ECOG) Performance Status; PD-L1=programmed death ligand-1; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease.

PATIENT CHARACTERISTICS

Selected baseline characteristics (includes patients from both arms of the study)

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*Using the VENTANA PD-L1 (SP263) assay, PD-L1-positive status was defined as PD-L1 expression in ≥25% of tumor cells or in ≥25% or 100% of tumor-associated immune cells if the percentage of immune cells was >1% or ≤1%, respectively. If none of these criteria were met, PD-L1 status was considered negative.

Efficacy

 

Safety profile

 

Reference: 1. 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.