Bavencio - Safety

Safety

Adverse reaction profile⁵

Primary analysis, data cutoff October 21, 2019⁴

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

^*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. ^‡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. ^§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. ^IICough is a composite term that includes cough and productive cough.

BSC=best supportive care

Discontinuations

12%

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

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 infusion due to infusion-related reactions)

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%)

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

BSC=best supportive care.

1. Cathomas R, Lorch A, Bruins HM, et al. The 2021 updated European Association of Urology guidelines on metastatic urothelial carcinoma. Eur Urol. 2022;81(1):95-103. doi:10.1016/j.eururo.2021.09.026 2. Galsky M, Balar A, Black P, et al. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer. J Immunother Cancer. 2021;9:e002552. doi:10.1136/jitc-2021-002552 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Bladder Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed May 25, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 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. 4. 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. 5. Bavencio. Prescribing Information. EMD Serono, Inc.; 2023. 6. Grivas P, Park SH, Voog E, et al. Avelumab first-line maintenance therapy for advanced urothelial carcinoma: comprehensive clinical subgroup analyses from the JAVELIN Bladder 100 Phase 3 Trial. Eur Urol. 2023;84(1):95-108. 7. 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. 8. Data on file. EMD Serono, Inc., Rockland, MA. 9. US Food and Drug Administration. FDA approves avelumab for urothelial carcinoma maintenance treatment. News release. June 30, 2020. Accessed December 20, 2022. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approvesavelumab-urothelial-carcinoma-maintenance-treatment 10. US Food and Drug Administration. FDA approves nivolumab for adjuvant treatment of urothelial carcinoma. News release. August 19, 2021. Accessed December 20, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma 11. Bajorin D, Witjes J, Gschwend J, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384:2102-2014. doi:10.1056/NEJMoa2034442.

Primary analysis, data cutoff October 21, 2019⁴

Fatal adverse reaction	A fatal adverse reaction (sepsis) occurred in one (0.3%) patient receiving BAVENCIO + supportive care (BSC)
Serious adverse reactions	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%)
Infusion-related reactions	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%)
Oral steroid use	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 reaction profile5

Primary analysis, data cutoff October 21, 20194

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

Adverse reaction profile⁵

Primary analysis, data cutoff October 21, 2019⁴