* Based on number of subjects with confirmed response (CR or PR).
*Baseline target and/or non-target lesions present outside the lymph nodes.
Prior anti-cancer therapies for the treatment of UC before receiving BAVENCIO (n=226)
of patients had received 2 or more lines of therapy1
In a Phase 1, open-label, single-arm, multicenter trial of 242 patients with locally advanced or metastatic UC with disease progression on or after platinum-containing chemotherapy
There were no clear differences in response rates based on PD-L1 tumor expression.
CI, confidence interval.
Among responding patients followed for ≥ 6 months(n=26)
Among the responding patients followed for ≥13 weeks (n=30)
The median duration of response was not estimable (range: 1.4+ to 17.4+ months).
+ denotes a censored value.
26 of 161 patients followed for ≥ 6 months had a complete or partial response2
In the UC cohorts of the JAVELIN Solid Tumors trial2:
aIncludes abdominal discomfort, abdominal pain upper and lower, and gastrointestinal pain.
bIncludes asthenia and malaise.
cInfusion-related reaction is a composite term that includes chills, pyrexia, back pain, flushing, dyspnea, and hypotension.
dIncludes edema, generalized edema, and peripheral swelling.
eIncludes urosepsis, cystitis, kidney infection, pyuria, and urinary tract infection due to fungus, bacterial, and enterococcus.
fIncludes back pain, myalgia, neck pain, and pain in extremity.
gIncludes acute kidney injury and glomerular filtration rate decreased.
hIncludes dermatitis acneiform, eczema, erythema, erythema multiforme, erythematous, macular, maculopapular, papular, and pruritic rash.
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References: 1. Patel MR, Ellerton J, Infante JR. et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2. Data on file. Rockland, Mass: EMD Serono, Inc; 2017. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer. V.5.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed September 26, 2018. To view the recent and complete version of the guideline, go online to NCCN.org.