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Avelumab

(Bavencio®)

Avelumab

Drug updated on 11/5/2024

Dosage FormInjection (intravenous; 200 mg/10 mL [20 mg/mL])
Drug ClassProgrammed death ligand-1 (PD-L1) blocking antibodies
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for Merkel Cell Carcinoma (MCC): Adults and pediatric patients 12 years and older with metastatic MCC
  • Indicated for Urothelial Carcinoma (UC): Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy, patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, and patients with locally advanced or metastatic UC who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Indicated for Renal Cell Carcinoma (RCC): First-line treatment, in combination with axitinib, of patients with advanced RCC.

Latest News

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Summary
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  • This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
  • Avelumab + axitinib showed an overall response rate (ORR) of 51.5%-58%, compared to 25.5% with sunitinib, and likely improves overall survival (OS) versus sunitinib, though specific hazard ratios were not provided.
  • Avelumab + axitinib reduced progression-free survival (PFS) compared to sunitinib (HR 1.45, 95% CI 1.17 to 1.80).
  • Pembrolizumab + axitinib and nivolumab + ipilimumab were more effective in improving OS and PFS compared to sunitinib, while pembrolizumab + axitinib showed better PFS than avelumab + axitinib.
  • Avelumab + axitinib was particularly effective in patients with PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
  • Avelumab + axitinib was associated with a worse safety profile, with higher rates of adverse events (AEs) and serious adverse events (SAEs) compared to sunitinib and monotherapies.
  • Avelumab demonstrated fewer treatment-related adverse events (TRAEs) compared to chemotherapy, with a lower incidence of high-grade TRAEs in advanced urothelial carcinoma and fewer treatment-related AEs in advanced non-small cell lung cancer (NSCLC) patients.
  • Avelumab + axitinib demonstrated significant effectiveness in previously untreated adults with metastatic clear cell renal cell carcinoma (RCC) across various risk groups, and was effective in PD-L1 positive patients with RCC and recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Product Monograph / Prescribing Information

Document TitleYearSource
Bavencio (avelumab) Prescribing Information.2024EMD Serono, Inc., Boston, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative safety of tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis2023Frontiers in Pharmacology
First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis2023The Cochrane Database of Systematic Reviews
Efficacy and Safety of Checkpoint Inhibitors in Clear Cell Renal Cell Carcinoma: A Systematic Review of Clinical Trials2023Hematology/Oncology and Stem Cell Therapy
Switch Maintenance Therapy for Metastatic Urothelial Carcinoma2022Bladder Cancer (Amsterdam, Netherlands)
A Bayesian network analysis of immunotherapy and taxane chemotherapy as second- or later-line treatments in non-small cell lung cancer2022Medicine
Immune checkpoint inhibitors in head and neck squamous cell carcinoma: A systematic review of phase-3 clinical trials2022World Journal of Clinical Oncology
Comparative Efficacy and Safety of Anti-PD-1/PD-L1 for the Treatment of Non-Small Cell Lung Cancer: A Network Meta-Analysis of 13 Randomized Controlled Studies2022Frontiers in Oncology
How Immunotherapy Modified the Therapeutic Scenario of Endometrial Cancer: A Systematic Review2022Frontiers in Oncology
The relationship between blood-based tumor mutation burden level and efficacy of PD-1/PD-L1 inhibitors in advanced non-small cell lung cancer: a systematic review and meta-analysis2021BMC Cancer
Systemic therapy for metastatic renal cell carcinoma in the first-line setting: a systematic review and network meta-analysis2021Cancer Immunology
The efficiency and safety of immune checkpoint inhibitors in the treatment of small cell lung cancer: a meta-analysis2020Annals of Palliative Medicine
Rationale and Outcomes for Neoadjuvant Immunotherapy in Urothelial Carcinoma of the Bladder2020European Urology Oncology
Targeted therapy for metastatic renal cell carcinoma2020The Cochrane Database of Systematic Reviews
Checkpoint inhibitors in advanced nonsmall-cell lung cancer; a Bayesian network meta-analysis2020Journal of Cancer Research and Therapeutics
The clinical significance of routine risk categorization in metastatic renal cell carcinoma and its impact on treatment decision-making: a systematic review2020Future Oncology (London, England)
Safety evaluation of immune-based combinations in patients with advanced renal cell carcinoma: a systematic review and meta-analysis2020Expert Opinion on Drug Safety
Comparative Efficacy of First-Line Immune-Based Combination Therapies in Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-Analysis2020Cancers
Combination Therapy for Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis2020American Journal of Clinical Oncology
The efficacy and safety of immunotherapy targeting the PD-1 pathway for advanced urothelial carcinoma: a meta-analysis of published clinical trials2020Clinical & Translational Oncology
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 Review2019Frontiers in Pharmacology

Clinical Practice Guidelines

Document TitleYearSource
Avelumab first-line maintenance treatment in advanced bladder cancer: practical implementation steps for infusion nurses2022Journal of Infusion Nursing
NCCN guidelines® insights: bladder cancer, version 2.20222022Journal of the National Comprehensive Cancer Network
SEOM clinical guideline for treatment of kidney cancer (2019)2020Clinical and Translational Oncology
Bladder cancer, version 3.20202020Journal of the National Comprehensive Cancer Network