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BAVENCIO® (avelumab) was studied in the UC cohorts (N=242) of the JAVELIN Solid Tumor trial, a Phase 1, open-label, single-arm, multicenter trial

* Based on number of subjects with confirmed response (CR or PR).

  • Patients were included regardless of their PD-L1 status
  • Tumor response assessments were performed every 6 weeks
    • Assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Patients were premedicated with antihistamine and acetaminophen prior to each infusion
  • The median duration of exposure to BAVENCIO was 12 weeks (range: 2 to 92 weeks)

The JAVELIN Solid Tumor UC cohorts included a wide range of previously treated patients

Characteristics of patients with disease progression on or after platinum-containing therapy (n=226)

  • 44% of patients had non-bladder UC (such as renal pelvis, ureters, and urethra), including 23% of patients with upper tract disease

*Baseline target and/or non-target lesions present outside the lymph nodes.

  • Key trial exclusion criteria included active or history of central nervous system (CNS) metastases; other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression; active infection with HIV, hepatitis B, or hepatitis C; and autoimmune disease (other than type 1 diabetes, vitiligo, psoriasis, or thyroid disease that did not require immunosuppressive treatment)

Many patients in the trial were heavily pretreated

Prior anti-cancer therapies for the treatment of UC before receiving BAVENCIO (n=226)

~50% (n=124/249)

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

Overall responses were achieved with BAVENCIO

  • 5.6% complete response (n=9/161)
  • 10.6% partial response (n=17/161)
  • 4.0% complete response (n=9/226)
  • 9.3% partial response (n=21/226)

There were no clear differences in response rates based on PD-L1 tumor expression.

CI, confidence interval.

BAVENCIO demonstrated durable responses

Among responding patients followed for ≥ 6 months(n=26)

  • 85% (n=22/26) of responses lasted for at least 6 months (range: 1.4 to 17.4+ months)
  • 15% (n=4/26) of responses lasted for at least 1 year (range: 1.4 to 17.4+ months)
  • Durable responses that extended beyond 1 year
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Among the responding patients followed for ≥13 weeks (n=30)

  • 73% of responses lasted for at least 6 months (n=22/30)
  • 13% of responses lasted for at least 1 year (n=4/30)

The median duration of response was not estimable (range: 1.4+ to 17.4+ months).

+ denotes a censored value.

85% (n=22/26) of responses to BAVENCIO lasted for at least 6 months

26 of 161 patients followed for ≥ 6 months had a complete or partial response2

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In the UC cohorts of the JAVELIN Solid Tumors trial2:

  • Tumor response assessments were performed every 6 weeks
  • The majority of responses were seen by the time of the first or second observation
  • 85% (n=22/26) of responses were ongoing at the time of data cutoff

Adverse reactions (≥ 10%) in previously treated locally advanced or metastatic UC

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.

Adverse reactions from the JAVELIN Solid Tumor UC cohorts (N=242)

  • The most common adverse reactions (≥ 20%) in patients with locally advanced or metastatic UC were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite (21%), and urinary tract infection (21%)
  • The most common Grade 3 and 4 adverse reactions (≥ 3%) were anemia, fatigue, hyponatremia, hypertension, urinary tract infection, and musculoskeletal pain
  • Fourteen patients (6%) who were treated with BAVENCIO experienced either pneumonitis, respiratory failure, sepsis/urosepsis, cerebrovascular accident, or gastrointestinal adverse events, which led to death
  • Grade 1-4 serious adverse reactions were reported in 41% of patients
  • The most frequent serious adverse reactions reported in ≥ 2% of patients were urinary tract infection/urosepsis, abdominal pain, musculoskeletal pain, creatinine increased/renal failure, dehydration, hematuria/urinary tract hemorrhage, intestinal obstruction/small intestine obstruction, and pyrexia
  • BAVENCIO was permanently discontinued for Grade 1-4 adverse reactions in 30 (12%) patients
    • The adverse reaction that resulted in permanent discontinuation in > 1% of patients was fatigue
  • BAVENCIO was temporarily discontinued in 29% of patients for adverse reactions, excluding temporary dose interruption for infusion-related reactions where infusion was restarted the same day
    • The adverse reactions that resulted in temporary discontinuation in > 1% of patients were diarrhea, fatigue, dyspnea, urinary tract infection, and rash
  • Eleven (4.5%) patients received an oral prednisone dose equivalent to ≥ 40 mg daily for an immune-mediated adverse reaction

Avelumab (BAVENCIO)

RECOMMENDED by the National Comprehensive Cancer Network® (NCCN®) as an option for patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (category 2A)3

The 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.

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.