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Bavencio (avelumab)
Bavencio blocks the PD-L1 protein, allowing the immune system to recognize and attack cancer cells.
Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocker developed by EMD SERONO INC. It works by blocking the PD-L1 protein, which cancer cells use to evade the immune system. Bavencio is approved for the maintenance therapy of unresectable urothelial carcinoma, Merkel cell carcinoma, and renal cell carcinoma. It is a patented product with a half-life of 6.1 days. Key safety considerations include immune-mediated adverse reactions.
At a glance
| Generic name | avelumab |
|---|---|
| Sponsor | Merck KGaA |
| Drug class | Programmed Death Ligand-1 Blocker [EPC] |
| Target | Programmed cell death 1 ligand 1 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 400 |
Mechanism of action
PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth.
Approved indications
- Maintenance therapy of unresectable urothelial carcinoma in patients who have received chemotherapy
- Merkel cell carcinoma
- Renal cell carcinoma
Common side effects
- Fatigue
- Musculoskeletal pain
- Diarrhea
- Nausea
- Infusion-related reaction
- Rash
- Decreased appetite
- Peripheral edema
- Urinary tract infection
- Hypertension
- Mucositis
- Palmar-plantar erythrodysesthesia
Key clinical trials
- A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) (PHASE3)
- Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) (PHASE2)
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2,PHASE3)
- Targeted Therapy and Avelumab in Merkel Cell Carcinoma (PHASE1,PHASE2)
- A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy (PHASE2)
- Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy (PHASE1,PHASE2)
- Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study (PHASE3)
- Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bavencio CI brief — competitive landscape report
- Bavencio updates RSS · CI watch RSS
- Merck KGaA portfolio CI