Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 200 mg/10 mL [20 mg/mL]) |
| Drug Class | Programmed 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).
Summary
- 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 suffering from advanced renal cell carcinoma.
- The information provided comes from a total of 13 systematic reviews/meta-analyses documents that provide detailed analyses comparing Bavencio to other immunotherapy and tyrosine kinase inhibitor drugs across various indications including Merkel cell carcinoma, urothelial carcinoma, renal cell carcinoma among others.
- In terms of safety profiles and efficacy measures like overall survival rate (OS), progression-free survival (PFS), and overall response rate (ORR), Bavencio shows promise especially when used in combination therapies but its effectiveness tends to be context-dependent varying by cancer type.
- For Metastatic Renal Cell Carcinoma specifically, one study indicates that Avelumab combined with axitinib could potentially be the preferred option due to benefits seen in PFS rates; however, another study suggests pembrolizumab plus axitinib might slightly edge out this combination both on efficacy and safety fronts, indicating nuanced differences between these therapies based on patient responses and adverse event profiles.
- While specific comparative data isn't available for Urothelial Carcinoma indication using Bavencio alone, adding ICIs to platinum-based chemotherapy has shown different toxicity profiles - combinations involving avelumab may lead to higher adverse event rates than some other ICIs.
- In Non-Small Cell Lung Cancer cases, comparison studies show less improvement in PFS using avelumab compared to pembrolizumab, which also had the highest OS benefits. Pembrolizumab also appeared superior in terms of safety when combined with chemotherapy, suggesting avelumab might not be the first choice for a second-line treatment setting based on available data.
- For advanced Endometrial Cancer cases, Bavencio has shown effectiveness offering an ORR ranging from 26.7% to 58% among microsatellite instability-high (MSI-H) patients; combination therapies involving ICIs and TKIs including avelumab indicated higher ORRs and were more effective than monotherapy but came with increased toxicity.
- The safety profile of Bavencio, both as monotherapy and in combinations, needs careful consideration - a network meta-analysis assessing ICIs for cancer treatment found differing risk profiles for adverse events, some combinations involving Bavencio presented significant toxicity concerns especially for grade 3-5 adverse events.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Bavencio (Avelumab) Prescribing Information. | 2024 | EMD Serono, Inc., Rockland, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Avelumab first-line maintenance treatment in advanced bladder cancer: practical implementation steps for infusion nurses. | 2022 | Journal of Infusion Nursing |
| NCCN guidelines® insights: bladder cancer, version 2.2022. | 2022 | Journal of the National Comprehensive Cancer Network |
| SEOM clinical guideline for treatment of kidney cancer (2019). | 2020 | Clinical and Translational Oncology |
| Bladder cancer, version 3.2020. | 2020 | Journal of the National Comprehensive Cancer Network |