SAFETY

BAVENCIO® (avelumab)–An Established Safety Profile1

Safety was evaluated in more than 1700 patients across several indications and clinical trials1

ADVERSE REACTIONS

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=689)1,2
 

Selected Adverse Reactions
Primary analysis, data cutoff October 21, 20191,2
 

  • 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 + BSC1,2

Primary Analysis, Data Cutoff October 21, 20192

Safety Profile Chart

*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 maculopapular, 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.

 

Discontinuations and Dose Interruptions Due to an Adverse Reaction1
 

Discontinuations

12%

of patients in the BAVENCIO + BSC arm (n=344) permanently discontinued treatment due to an adverse reaction

  • Adverse reactions resulting in permanent discontinuation of BAVENCIO in >1% of patients were myocardial infarction (including acute myocardial infarction and troponin T increased) (1.5%) and infusion-related reaction (1.2%)

Interruptions

41%

of patients in the BAVENCIO + BSC (n=344) arm experienced a dose interruption due to an adverse reaction (excluding temporary interruptions of BAVENCIO infusions due to infusion-related reactions)

  • Adverse reactions leading to interruption of BAVENCIO in >2% of patients were urinary tract infection (including pyelonephritis) (4.7%) and blood creatinine increased (including acute kidney injury, renal impairment, and renal failure) (3.8%)
IMMUNE-MEDIATED ADVERSE REACTIONS

Immune-mediated adverse reactions in the JAVELIN Bladder 100 Trial2
 

Incidence rate

29.4%

of patients (n=101) treated with BAVENCIO + BSC experienced an immune-mediated adverse reaction

  • Twenty-four patients (7%) were Grade 3

Corticosteroid usage

9%

of patients (n=31) treated with BAVENCIO + BSC received an oral prednisone dose equivalent to ≥40 mg daily for an immune-mediated adverse reaction

SELECT LONG-TERM SAFETY DATA

19.5% of patients were still receiving treatment with BAVENCIO after 2 years3

Discontinuations and Dose Interruptions Due to an Adverse Reaction: Long-term Analysis4

Discontinuations

10.2%

of patients (n=118) in the BAVENCIO + BSC arm discontinued treatment after ≥12 months of treatment because of treatment-related ARs    

Interruptions

36.4%

of patients (n=118) in the BAVENCIO + BSC arm had ARs leading to dose interruption after ≥12 months of treatment

 
  • 11.9% of patients (n=118) in the BAVENCIO + BSC arm had grade 3 or higher treatment-related ARs after ≥12 months of treatment

No new safety signals were seen in the long-term analysis3

Review dose modification guidelines for immune-mediated adverse reactions.

LABORATORY ABNORMALITIES

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=689)1,2

Selected laboratory abnormalities worsening from baseline occurring in ≥10% of patients receiving BAVENCIO + BSC1,2

Primary analysis, data cutoff October 21, 20192

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).

How Bavencio Works and Dosage Guidelines

References: 1. Bavencio. Prescribing information. EMD Serono, Inc; 2023. 2. 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. 3. 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;JCO2201792. doi:10.1200/JCO.22.01792. Online ahead of print. 4. 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 [supplementary appendix]. J Clin Oncol. 2023;JCO2201792. doi:10.1200/JCO.22.01792. Online ahead of print.