SAFETY

An Established Safety Profile1,2

SUMMARY OF ADVERSE REACTIONS

PRIMARY ANALYSIS: Adverse Reactions1

  • A fatal adverse reaction (sepsis) occurred in one patient (0.3%) receiving BAVENCIO + best supportive care (BSC) 
  • Serious adverse reactions occurred in 28% of patients receiving BAVENCIO + BSC. Serious adverse reactions in ≥1% of patients included urinary tract infection (including kidney infection, pyelonephritis, and urosepsis) (6.1%), pain (including abdominal, back, bone, flank, extremity, and pelvic pain) (3.2%), acute kidney injury (1.7%), hematuria (1.5%), sepsis (1.2%), and infusion-related reaction (1.2%) 
  • Patients received premedication with an antihistamine and acetaminophen prior to each infusion. Infusion-related reactions occurred in 10% of patients treated with BAVENCIO + BSC (Grade 3: 0.9%)
  • Thirty-one (9%) patients treated with BAVENCIO + BSC received an oral prednisone dose equivalent to ≥40 mg daily for an immune-mediated adverse reaction

Adverse reactions (≥10%) of patients receiving BAVENCIO + BSC1

Safety Profile Chart

aFatigue is a composite term that includes fatigue, asthenia, and malaise.

bMusculoskeletal pain is a composite term that includes musculoskeletal pain, back pain, myalgia, and neck pain.

cRash is a composite term that includes rash, rash maculopapular, erythema, dermatitis acneiform, eczema, erythema multiforme, rash erythematous, rash macular, rash papular, rash pruritic, drug eruption, and lichen planus.

dUrinary 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.

eCough is a composite term that includes cough and productive cough.

ADVERSE REACTIONS IN PRIMARY AND LONG-TERM ANALYSIS

PRIMARY
ANALYSIS3

TRARs (77.3% of patients)

16.6

%

of patients had

a Grade 3 TRAR

 

 

irARs (29.4% of patients)

7.0

%

of patients had

a Grade 3 irAR

 

 

Treatment discontinuation due to ARs: 11.9%

 

 

Treatment discontinuation due to TRARs: 9.6%

LONG-TERM
ANALYSIS2

TRARs (78.2% of patients)

19.5

%

of patients had

a Grade 3 TRAR

 

 

irARs (32.3% of patients)

7.6

%

of patients had

a Grade 3 irAR

 

 

Treatment discontinuation due to ARs: 14.2%

 

 

Treatment discontinuation due to TRARs: 11.6%

NO NEW SAFETY SIGNALS OBSERVED IN THE LONG-TERM ANALYSIS (MEDIAN FOLLOW-UP,
38 MONTHS)2

NEARLY

20%

of patients were still receiving treatment with BAVENCIO
after 2 years (median duration,
5.8 months)2

LABORATORY ABNORMALITIES

PRIMARY ANALYSIS: Selected laboratory abnormalities worsening from baseline occurring in ≥10% of patients receiving BAVENCIO + BSC1

Laboratory Abnormalities Chart

*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).

 

AR = Adverse reaction; BSC=best supportive care; irAR=immune-mediated adverse reaction; TRAR=treatment-related adverse reaction.

View Patient Profiles and Dosing

References: 1. Bavencio Prescribing Information. EMD Serono, Inc.; 2024. 2. 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. 3. 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.