JAVELIN Bladder 100 Trial—a Phase 3, randomized, open-label, multicenter study in patients with unresectable, locally advanced or metastatic urothelial carcinoma that did not progress with first-line platinum containing chemotherapy (N=700)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 active 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.
JAVELIN Bladder 100 Trial—a Phase 3, randomized, open-label, multicenter study in patients with unresectable, locally advanced or metastatic urothelial carcinoma that did not progress with first-line platinum-containing chemotherapy (N=700)1
All randomized patients (major efficacy outcome measure)
*P-value based on stratified log-rank.
CI=confidence interval; PD-1=programmed death-1 receptor; PD-L1=programmed death ligand-1.
†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.1
JAVELIN Bladder 100 Trial—a Phase 3, randomized, open-label, multicenter study in patients with unresectable, locally advanced or metastatic urothelial carcinoma that did not progress with firstline platinum-containing chemotherapy (N=689)1
*Fatigue is a composite term that includes fatigue, asthenia, and malaise.
†Musculoskeletal pain is a composite term that includes musculoskeletal pain, back pain, myalgia, and neck pain.
‡Rash is a composite term that includes rash, rash maculo-papular, erythema, dermatitis acneiform, eczema, erythema multiforme, rash erythematous, rash macular, rash papular, rash pruritic, drug eruption, and lichen planus.
§Urinary tract infection is a composite term that includes urinary tract infection, urosepsis, cystitis, kidney infection, pyuria,pyelonephritis, bacteriuria, pyelonephritis acute, urinary tract infection bacterial, and Escherichia urinary tract infection.
llCough is a composite term that includes cough and productive cough.
*Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: BAVENCIO + BSC group (range: 339 to 344 patients) and BSC group (range: 329 to 341 patients).
National Comprehensive Cancer Network® (NCCN) Recommendation
Avelumab maintenance therapy (category 2A) is recommended as part of a preferred regimen as an option for first-line systemic therapy in patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.2
Category 2A=Based upon lower-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.
References: 1. Data on file. Rockland, Mass: EMD Serono, Inc. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.6.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed July 17, 2020. To view the most recent and complete version of the guidelines, go online to NCCN.org. 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.