Avelumab

(Bavencio®)

Avelumab

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 200 mg/10 mL [20 mg/mL])
Drug ClassProgrammed death-ligand1 blocking antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
  • Indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
  • Indicated for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • Indicated for first-line treatment, in combination with axitinib, of patients with advanced renal cell carcinoma (RCC).

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Summary
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  • Avelumab (Bavencio) is indicated for adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, as well as the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. It is also used in cases where disease progression occurs during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with such therapy. Additionally, it is indicated for first-line treatment in combination with axitinib for patients with advanced renal cell carcinoma.
  • The information was derived from a total of 15 systematic reviews/meta-analyses focusing on Bavencio (avelumab), comparing its safety and efficacy across various indications to other drugs within similar therapeutic categories, including immune checkpoint inhibitors and combination treatments involving tyrosine kinase inhibitors and chemotherapies.
  • When combined with tyrosine kinase inhibitors like axitinib, Bavencio demonstrates potential advantages in terms of efficacy and safety profile when treating advanced renal cell carcinoma compared to monotherapy or other combinations involving immune checkpoint inhibitors.
  • As a monotherapy, compared to combination therapies using immune checkpoint inhibitors along with chemotherapies/tyrosine kinase inhibitors, Avelumab presents a more favorable safety profile. However, the choice between using it alone versus combining it with others depends upon balancing anticipated benefits against possible adverse effects.
  • Its applicability across multiple types of cancers reflects its broad therapeutic potential; specifically notable is its unique benefit in addressing Merkel Cell Carcinoma, which adds an important aspect to its overall profile among available cancer treatments.
  • Efficacy metrics such as progression-free survival (PFS) and overall survival (OS), either when used alone or as part of a regimen, are competitive within the landscape of available treatments, especially where high PD-L1 expression or MSI-high tumors exist, making it a favorable alternative over traditional chemotherapy options.
  • Clinical evidence suggests variable response rates and tolerability profiles among different patient subgroups, influenced by cancer type, staging, and biomarker status such as PD-L1 expression and microsatellite instability (MSI) status. This necessitates personalized medicine approaches in cancer treatment.
  • The contrasting efficacy and safety profiles between monotherapies versus combination therapies across different types of malignancies underline the complexity of therapeutic decision-making to optimize patient outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Bavencio (Avelumab) Prescribing Information. 2024EMD Serono, Inc., Rockland, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and toxicity of immune checkpoint inhibitors combination therapy for advanced renal cell carcinoma: a systematic review and network meta-analysis.2024Frontiers in Immunology
Comparative safety of tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis.2023Frontiers in Pharmacology
The safety of combining immune checkpoint inhibitors and platinum-based chemotherapy for the treatment of solid tumors: a systematic review and network meta-analysis.2023Frontiers in Immunology
Efficacy and safety of first-line systemic therapy for metastatic renal cell carcinoma: a systematic review and network meta-analysis. 2022European Urology Open Science
A Bayesian network analysis of immunotherapy and taxane chemotherapy as second- or later-line treatments in non-small cell lung cancer.2022Medicine Open
How immunotherapy modified the therapeutic scenario of endometrial cancer: a systematic review.2022Frontiers in Oncology
How immunotherapy modified the therapeutic scenario of endometrial cancer: a systematic review.2022Frontiers in Oncology
Immune checkpoint inhibitors in head and neck squamous cell carcinoma: a systematic review of phase-3 clinical trials.2022World Journal of Clinical Oncology
Comparative efficacy and safety of PD-1/PD-L1 inhibitors for patients with solid tumors: a systematic review and Bayesian network meta-analysis.2021Journal of Cancer
Systemic therapy for metastatic renal cell carcinoma in the first-line setting: a systematic review and network meta-analysis.2021Cancer Immunology
A network meta-analysis of efficacy and safety of first-line and second-line therapies for the management of metastatic renal cell carcinoma.2021Journal of Clinical Pharmacy and Therapeutics
Targeted therapy for metastatic renal cell carcinoma. 2020The Cochrane Database of Systematic Reviews
Comparative risk of serious and fatal treatment-related adverse events caused by 19 immune checkpoint inhibitors used in cancer treatment: a network meta-analysis. 2020Therapeutic Advances in Medical Oncology
Systemic therapy for metastatic renal cell carcinoma in the first‑line setting: a systematic review and network meta‑analysis.2020Cancer Immunology
The differences in the safety and tolerability of immune checkpoint inhibitors as treatment for non-small cell lung cancer and melanoma: network meta-analysis and systematic review.2019Frontiers in Pharmacology

Clinical Practice Guidelines

Document TitleYearSource
Avelumab first-line maintenance treatment in advanced bladder cancer: practical implementation steps for infusion nurses.2022Journal of Infusion Nursing
NCCN guidelines® insights: bladder cancer, version 2.2022.2022Journal of the National Comprehensive Cancer Network
SEOM clinical guideline for treatment of kidney cancer (2019).2020Clinical and Translational Oncology
Bladder cancer, version 3.2020.2020Journal of the National Comprehensive Cancer Network