avelumab
Trade name: bavencio
mAbapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Mar 23, 2017
Avelumab, sold under the brand name Bavencio, is a fully human monoclonal antibody medication for the treatment of Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma. — Wikipedia
Clinical trial activity
233 trials · 167 clinical orgs · 2 marketing orgs
Phase 1
88
Phase 2
186
Phase 3
20
Phase 4
1
Earliest trial started Jan 31, 2013 (NCT01772004)
Timeline
2010s
- Jan 1, 2013
Merck Serono — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
Merck Serono — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2015
Merck Serono — Earliest Phase 3 Sponsor(trial)
- Sep 21, 2015
Orphan Drug Designation
- Mar 23, 2017
Pfizer — Earliest FDA Approval
- Mar 23, 2017
Merck Serono — Marketing Organization
- Mar 23, 2017
Pfizer — NDA Organization
- Mar 23, 2017
Merck Serono — NDA Secondary Org
Indications
Studied for
- Adenocarcinoma · Phase 1
- Antineoplastic Agents · Phase 2
- Biliary Tract Neoplasms · Phase 1/Phase 2
- Biomarkers · Phase 2
- Bone Marrow Diseases · Phase 2
- BRCA1 Protein · Phase 2
- Breast Neoplasms · Phase 2
- Carcinoma · Phase 1/Phase 2
- Carcinoma, Adenoid Cystic · Phase 2
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Neuroendocrine · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Ovarian Epithelial · Phase 1/Phase 2
- Carcinoma, Renal Cell · Phase 3
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 4
- Central Nervous System Neoplasms · Phase 1
- Cholangiocarcinoma · Phase 1/Phase 2
- Chordoma · Phase 1/Phase 2
- Colonic Neoplasms · Phase 3
- Colorectal Neoplasms · Phase 2
- Dermatology · Phase 1/Phase 2
- DNA Mismatch Repair · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Endometrial Neoplasms · Phase 2
- Esophageal Neoplasms · Phase 3
- Fallopian Tube Neoplasms · Phase 2
- Fibrosarcoma · Phase 1
- Gallbladder Neoplasms · Phase 1/Phase 2
- Gastrointestinal Stromal Tumors · Phase 1/Phase 2
- Genes, erbB-2 · Phase 2
- Gestational Trophoblastic Disease · Phase 2
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Gonadal Disorders · Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Hodgkin Disease · Phase 2
- Kidney Neoplasms · Phase 2
- Laryngeal Neoplasms · Phase 2
- Leiomyosarcoma · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Liposarcoma · Phase 1/Phase 2
- Lung Diseases · Phase 2
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 3
- Lymphoma, Extranodal NK-T-Cell · Phase 2
- Lymphoma, Follicular · Phase 1
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Anaplastic · Phase 1
- Lymphoma, Mantle-Cell · Phase 1
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, T-Cell · Phase 2
- Melanoma · Phase 2
- Meninges · Phase 1
- Meningioma · Phase 1
- Mesothelioma · Phase 1/Phase 2
- Microsatellite Instability · Phase 3
- Molecular Mechanisms of Pharmacological Action · Phase 2
- Multiple Myeloma · Phase 2
- Mutation · Phase 2
- Mycosis Fungoides · Phase 1
- Nasopharyngeal Carcinoma · Phase 2
- Nasopharyngeal Neoplasms · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasm, Residual · Phase 1/Phase 2
- Neoplasms · Phase 3
- Neoplasms, Germ Cell and Embryonal · Phase 2
- Neoplasms, Second Primary · Phase 2
- Neuroendocrine Tumors · Phase 2
- Osteosarcoma · Phase 2
- Ovarian Neoplasms · Phase 3
- Pancreatic Neoplasms · Phase 2
- Papillomaviridae · Phase 2
- Penile Neoplasms · Phase 2
- Peritoneal Neoplasms · Phase 1
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- ras Proteins · Phase 2
- Rectal Neoplasms · Phase 2
- Sarcoma · Phase 1/Phase 2
- Sezary Syndrome · Phase 1
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Stomach Neoplasms · Phase 3
- Testicular Diseases · Phase 2
- Testicular Neoplasms · Phase 2
- Thymoma · Phase 2
- Thyroid Neoplasms · Phase 1/Phase 2
- Triple Negative Breast Neoplasms · Phase 3
- Ureteral Neoplasms · Phase 3
- Urethral Neoplasms · Phase 3
- Urinary Bladder Neoplasms · Phase 3
- Uterine Cervical Neoplasms · Phase 2
- Vulvar Neoplasms · Phase 1/Phase 2
Mechanism of action
- Programmed cell death 1 ligand 1INHIBITOR
CD274 inhibitor
CD274 other
Avelumab binds to PD-L1 and prevents the interaction of PD-L1 with its receptor programmed cell death protein 1 (PD-1). This inhibits the activation of PD-1 and its downstream signalling pathways. This results in the activation of cytotoxic T-lymphocytes (CTLs) targeted to PD-L1-overexpressing tumor cells. In addition, avelumab induces an antibody-dependent cellular cytotoxic (ADCC) response against PD-L1-expressing tumor cells.
Approval history
- approvedPriority reviewAcceleratedFast trackBreakthroughMar 23, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaAvelumab ↗
- NCATSKXG2PJ551I ↗
- ChEMBLCHEMBL3833373 ↗
Also known as
- avelumab
- avelumab
- avelumab
- avelumab
- avelumab
- avelumab
- avelumab
- bavencio
- bavencio
- msb0010718c
- msb0010718c
- msb0010718c
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07110038 | Phase 2 | Oct 31, 2025 | Astellas, IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest, Institut für Klinische Krebsforschung IKF GmbH, Merck KGaA, University of Tuebingen |
| NCT07225374 | Phase 2 | Sep 16, 2025 | Sungkyunkwan University |
| NCT06939036 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2025 | Ariceum Therapeutics GmbH |
| NCT06839560 | Phase 2 | Mar 1, 2025 | Chinese Academy of Medical Sciences |
| NCT06869473 | Phase 2 | Feb 20, 2025 | Clinical Research Technology S.r.l., Gruppo Oncologico del Nord-Ovest, Merck Serono |
| NCT06518564 | Phase 2 | Jan 31, 2025 | Harvard University, Merck Serono |
| NCT06820255 | Phase 4 | Jan 7, 2025 | Universita' Cattolica del Sacro Cuore |
| NCT06640725 | Phase 2 | Dec 2, 2024 | Groupe Oncologie Radiotherapie Tete et Cou |
| NCT06557278 | Phase 2 | Nov 30, 2024 | Mirror Pharms |
| NCT06424717 | Phase 2 | Aug 16, 2024 | Merck KGaA, Merck Serono |
| NCT06228066 | Phase 2 | Jun 13, 2024 | National Cancer Institute (NCI) |
| NCT06302426 | Phase 1 | Mar 29, 2024 | Avance Clinical Pty Ltd., Inimmune Corporation |
| NCT06204614 | Early Phase 1 (Phase 1) | Feb 14, 2024 | Harvard University |
| NCT06225596 | Phase 2/Phase 3 (Phase 3) | Jan 24, 2024 | Bicycle Therapeutics |
| NCT05687721 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2024 | Bayer, Department of Veteran Affairs |
| NCT05947500 | Phase 2 | Dec 18, 2023 | National Cancer Institute (NCI), University of Washington |
| NCT05574504 | Phase 2 | Jan 31, 2023 | Advent Health, Jazz Pharmaceuticals |
| NCT05176288 | Phase 2 | Jan 15, 2023 | Harvard University, Pfizer |
| NCT05600127 | Phase 2 | Dec 31, 2022 | Erasmus University Rotterdam, Merck KGaA |
| NCT05249569 | Phase 2 | Nov 4, 2022 | Pfizer, The University of Texas, Dallas |
Showing 20 of 233 trials
Page 1 / 12
Organizations
Research & Development (167)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pfizer | For profit | 64 | 19 | 4 | 2015 |
| Merck KGaA | For profit | 49 | 4 | 4 | 2013 |
| Merck Serono | For profit | 34 | 14 | 3 | 2013 |
| National Cancer Institute (NCI) | Government | 29 | 14 | 3 | 2015 |
| NantWorks | For profit | 14 | 14 | 1 | 2017 |
| Harvard University | Academic/Hospital | 10 | 8 | 3 | 2016 |
| University of Texas at Houston | Academic/Hospital | 9 | 7 | 1 | 2017 |
| Gruppo Oncologico del Nord-Ovest | Academic/Hospital | 5 | 5 | 1 | 2018 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 5 | 5 | 2 | 2017 |
| University of London | Academic/Hospital | 5 | 3 | 2 | 2016 |
| University of Washington | Academic/Hospital | 5 | 4 | 2 | 2015 |
| Johns Hopkins University | Academic/Hospital | 4 | 1 | 1 | 2018 |
| Merck | For profit | 4 | 0 | 1 | 2018 |
| Sungkyunkwan University | Academic/Hospital | 4 | 3 | 1 | 2017 |
| University of California, San Diego | Academic/Hospital | 4 | 3 | 2 | 2016 |
| Breast Cancer Research Foundation | Academic/Hospital | 3 | 0 | 1 | 2018 |
| Free University of Brussels | Academic/Hospital | 3 | 3 | 1 | 2017 |
| Hoosier Cancer Research Network | Academic/Hospital | 3 | 2 | 1 | 2017 |
| Royal Marsden Hospital NHS Trust | Academic/Hospital | 3 | 3 | 3 | 2018 |
| University of Campania Luigi Vanvitelli | Academic/Hospital | 3 | 2 | 1 | 2018 |
167 organizations
Page 1 / 9
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck Serono | For profit | MKTG | Mar 23, 2017 |
| Merck Serono | For profit | NDA2 | Mar 23, 2017 |
| Pfizer | For profit | NDA | Mar 23, 2017 |