durvalumab
Trade name: imfinzi
Approved
May 1, 2017
Durvalumab, sold under the brand name Imfinzi, is an anti-cancer medication used for treatment of various types of cancer. It was developed by Medimmune/AstraZeneca. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1). — Wikipedia
Clinical trial activity
735 trials · 455 clinical orgs · 1 marketing orgs
Earliest trial started Aug 29, 2012 (NCT01693562)
Timeline
2010s
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
AstraZeneca — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2014
AstraZeneca — Earliest Phase 3 Sponsor(trial)
- May 1, 2017
AstraZeneca — Earliest FDA Approval
- May 1, 2017
AstraZeneca — Marketing Organization
- May 1, 2017
AstraZeneca — NDA Organization
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 2
- Adenocarcinoma of Lung · Phase 2
- Anaplastic Lymphoma Kinase · Phase 2
- Angiogenesis Modulating Agents · Phase 2
- Antibodies · Phase 2
- Anus Neoplasms · Phase 2
- Appendiceal Neoplasms · Phase 1/Phase 2
- Bile Duct Neoplasms · Phase 2
- Biliary Tract Neoplasms · Phase 3
- BRCA1 Protein · Phase 2
- Breast · Phase 1/Phase 2
- Breast Neoplasms · Phase 3
- Carcinoma · Phase 2
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Merkel Cell · Phase 1/Phase 2
- Carcinoma, Neuroendocrine · Phase 2
- Carcinoma, Ovarian Epithelial · Phase 2
- Carcinoma, Pancreatic Ductal · Phase 1
- Carcinoma, Renal Cell · Phase 3
- Carcinoma, Small Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 2/Phase 3
- Carcinoma, Transitional Cell · Phase 3
- Castration · Phase 2
- Central Nervous System Neoplasms · Phase 1
- Cholangiocarcinoma · Phase 2
- Cisplatin · Phase 3
- Colonic Neoplasms · Phase 2
- Colorectal Neoplasms · Phase 2
- Digestive System Diseases · Phase 1
- DNA Mismatch Repair · Phase 2
- DNA Repair-Deficiency Disorders · Phase 2
- Doxorubicin · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Drugs, Investigational · Phase 4
- Drug Therapy · Phase 2
- Dysgerminoma · Phase 2
- Endometrial Neoplasms · Phase 3
- Epstein-Barr Virus Infections · Phase 2
- Esophageal Neoplasms · Phase 2
- Esophageal Squamous Cell Carcinoma · Phase 3
- Esophagogastric Junction · Phase 3
- Fallopian Tube Neoplasms · Phase 2
- Fibrosis · Phase 2
- Gallbladder Neoplasms · Phase 2/Phase 3
- Gastrointestinal Neoplasms · Phase 3
- General Surgery · Phase 2
- Genital Neoplasms, Female · Phase 1
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Hematologic Neoplasms · Phase 1/Phase 2
- Hepatitis B, Chronic · Phase 2
- HIV · Phase 2
- Homologous Recombination · Phase 2
- Hormones · Phase 2
- Human papillomavirus 16 · Phase 2
- Hydronephrosis · Early Phase 1
- Hypertension, Portal · Phase 2
- Hypopharyngeal Neoplasms · Phase 2/Phase 3
- Hypopharynx · Phase 2
- Immune Checkpoint Inhibitors · Phase 3
- Immunotherapy · Phase 2
- Infusions, Intravenous · Phase 4
- Intestinal Neoplasms · Phase 1
- Kidney Neoplasms · Phase 2
- Klatskin Tumor · Phase 2
- Laryngeal Neoplasms · Phase 2/Phase 3
- Larynx · Phase 2
- Leiomyosarcoma · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Lip · Phase 1
- Lip Neoplasms · Phase 2
- Liposarcoma · Phase 2
- Liver Cirrhosis · Phase 2
- Liver Neoplasms · Phase 2
- Lung Neoplasms · Phase 3
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 1/Phase 2
- Lymphoma, Follicular · Phase 1/Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 1
- Lymphoma, Mantle-Cell · Phase 1
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, T-Cell · Phase 1/Phase 2
- Lymphoma, T-Cell, Cutaneous · Phase 1/Phase 2
- Melanoma · Phase 2
- Menopause · Phase 2
- Mesothelioma · Phase 3
- Mesothelioma, Malignant · Phase 3
- Methotrexate · Phase 3
- Microsatellite Instability · Phase 2
- Mouth Neoplasms · Phase 2/Phase 3
- Multiple Myeloma · Phase 2
- Mutation · Phase 2
- Mycosis Fungoides · Phase 1/Phase 2
- Myelodysplastic Syndromes · Phase 2
- Nasopharyngeal Carcinoma · Phase 2
- Neoplasm Metastasis · Phase 4
- Neoplasms, Germ Cell and Embryonal · Phase 2
- Neoplasm Staging · Phase 2
- Neuroendocrine Tumors · Phase 2
- Oropharyngeal Neoplasms · Phase 3
- Oropharynx · Phase 2
- Osteosarcoma · Phase 2
- Ovarian Diseases · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 3
- Pancreatic Neoplasms · Phase 2
- Papillomavirus Infections · Phase 2
- Penile Neoplasms · Phase 2
- Peritoneal Neoplasms · Phase 2
- Plasmacytoma · Phase 1
- Polycythemia Vera · Phase 1
- Primary Myelofibrosis · Phase 1
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Radiotherapy · Phase 2
- Rare Diseases · Phase 2
- Receptors, Fibroblast Growth Factor · Phase 2
- Rectal Neoplasms · Phase 2
- Recurrence · Phase 2
- Respiratory Tract Neoplasms · Phase 2
- Sarcoma · Phase 3
- Seminoma · Phase 2
- Sepsis · Phase 2
- Sezary Syndrome · Phase 1/Phase 2
- Small Cell Lung Carcinoma · Phase 3
- Smoldering Multiple Myeloma · Phase 1
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Stomach Neoplasms · Phase 2
- Testicular Neoplasms · Phase 2
- Thoracic Neoplasms · Phase 2
- Thyroid Neoplasms · Phase 2
- Triple Negative Breast Neoplasms · Phase 2
- Ureteral Neoplasms · Early Phase 1
- Urethral Neoplasms · Early Phase 1
- Urinary Bladder Diseases · Phase 2
- Uterine Cervical Neoplasms · Phase 3
- Uterine Neoplasms · Phase 2
- Vaginal Neoplasms · Phase 2
- Vinblastine · Phase 3
- Vulvar Neoplasms · Phase 2
Mechanism of action
MTFP1 inhibitor
- 80S RibosomeINHIBITOR
80S Ribosome inhibitor
- 60S ribosomal protein L39 (RPL39) ↗
- 60S ribosomal protein L41 (RPL41) ↗
- 40S ribosomal protein S15 (RPS15) ↗
- 40S ribosomal protein S15a (RPS15A) ↗
- 40S ribosomal protein S16 (RPS16) ↗
- 40S ribosomal protein S17 (RPS17) ↗
- 40S ribosomal protein SA (RPSA) ↗
- 40S ribosomal protein S18 (RPS18) ↗
- 40S ribosomal protein S19 (RPS19) ↗
- 40S ribosomal protein S20 (RPS20) ↗
- 40S ribosomal protein S21 (RPS21) ↗
- 40S ribosomal protein S23 (RPS23) ↗
- 40S ribosomal protein S24 (RPS24) ↗
- 40S ribosomal protein S25 (RPS25) ↗
- 40S ribosomal protein S27 (RPS27) ↗
- 40S ribosomal protein S26 (RPS26) ↗
- Ubiquitin-40S ribosomal protein S27a (RPS27A) ↗
- 40S ribosomal protein S28 (RPS28) ↗
- 40S ribosomal protein S29 (RPS29) ↗
- 40S ribosomal protein S30 (RS30) ↗
- 60S ribosomal protein L21 (RPL21) ↗
- 60S ribosomal protein L22 (RPL22) ↗
- 60S ribosomal protein L23 (RPL23) ↗
- 60S ribosomal protein L23a (RPL23A) ↗
- 60S ribosomal protein L24 (RPL24) ↗
- 40S ribosomal protein S6 (RPS6) ↗
- 60S ribosomal protein L26 (RPL26) ↗
- 60S ribosomal protein L27 (RPL27) ↗
- 60S ribosomal protein L27a (RPL27A) ↗
- 60S ribosomal protein L28 (RPL28) ↗
- 60S ribosomal protein L29 (RPL29) ↗
- 60S ribosomal protein L30 (RPL30) ↗
- 60S ribosomal protein L31 (RPL31) ↗
- 60S ribosomal protein L32 (RPL32) ↗
- 60S ribosomal protein L34 (RPL34) ↗
- 60S ribosomal protein L35 (RPL35) ↗
- 60S ribosomal protein L35a (RPL35A) ↗
- 60S ribosomal protein L36 (RPL36) ↗
- 60S ribosomal protein L36a (RPL36A) ↗
- 60S ribosomal protein L37 (RPL37) ↗
- 40S ribosomal protein S10 (RPS10) ↗
- 40S ribosomal protein S11 (RPS11) ↗
- 40S ribosomal protein S12 (RPS12) ↗
- 40S ribosomal protein S13 (RPS13) ↗
- 40S ribosomal protein S14 (RPS14) ↗
- 60S ribosomal protein L37a (RPL37A) ↗
- 40S ribosomal protein S2 (RPS2) ↗
- 40S ribosomal protein S3 (RPS3) ↗
- 40S ribosomal protein S3a (RPS3A) ↗
- 40S ribosomal protein S4, X isoform (RPS4X) ↗
- 40S ribosomal protein S4, Y isoform 1 (RPS4Y1) ↗
- 40S ribosomal protein S5 (RPS5) ↗
- 40S ribosomal protein S7 (RPS7) ↗
- 40S ribosomal protein S8 (RPS8) ↗
- 40S ribosomal protein S9 (RPS9) ↗
- 60S ribosomal protein L3 (RPL3) ↗
- 60S ribosomal protein L4 (RPL4) ↗
- 60S ribosomal protein L5 (RPL5) ↗
- 60S ribosomal protein L6 (RPL6) ↗
- 60S ribosomal protein L7 (RPL7) ↗
- 60S ribosomal protein L7a (RPL7A) ↗
- 60S ribosomal protein L8 (RPL8) ↗
- 60S ribosomal protein L9 (RPL9; RPL9P7; RPL9P8; RPL9P9) ↗
- 60S ribosomal protein L10 (RPL10) ↗
- 60S ribosomal protein L10a (RPL10A) ↗
- 60S ribosomal protein L11 (RPL11) ↗
- 60S ribosomal protein L12 (RPL12) ↗
- 60S ribosomal protein L13 (RPL13) ↗
- 60S ribosomal protein L13a (RPL13A) ↗
- 60S ribosomal protein L14 (RPL14) ↗
- 60S ribosomal protein L15 (RPL15) ↗
- 60S ribosomal protein L17 (RPL17) ↗
- 60S ribosomal protein L18 (RPL18) ↗
- 60S ribosomal protein L18a (RPL18A) ↗
- 60S ribosomal protein L19 (RPL19) ↗
- 60S ribosomal protein L38 (RPL38) ↗
- 60S acidic ribosomal protein P0 (RPLP0) ↗
- 60S acidic ribosomal protein P1 (RPLP1) ↗
- Mucin-1BINDING AGENT
Mucin-1 binding agent
- Unspecified targetOTHER
Immunostimulant
Antibody fused to tumor-targeted superantigen.
- Programmed cell death 1 ligand 1INHIBITOR
CD274 inhibitor
Blocks PD-L1 binding to PD-1 (IC50 0.1 nM) and CD80 (IC50 0.04 nM).
- Trophoblast glycoproteinCROSS-LINKING AGENT
TPBG cross-linking agent
Approval history
- approvedPriority reviewAcceleratedBreakthroughMay 1, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Multi-specific
- No
- Payload
- Staphylococcal enterotoxin A
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaDurvalumab ↗
- NCATS28X28X9OKV ↗
- ChEMBLCHEMBL3301587 ↗
- ChEMBLCHEMBL2108151 ↗
Also known as
- duravalumab
- durvalumab
- durvalumab
- durvalumab
- durvalumab
- durvalumab
- imfinzi
- imfinzi
- iph5401 and durvalumab
- medi4736
- medi-4736
- medi-4736
- nacolomab tafenatox
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07288034 | Phase 2 | Sep 21, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07247786 | Phase 2 | Mar 15, 2026 | Fundación GECP, Grupo Español de Cáncer de Pulmón |
| NCT07226063 | Phase 2 | Feb 28, 2026 | Case Western Reserve University, Exelixis |
| NCT07122089 | Phase 2 | Jan 2, 2026 | Boston Scientific Corporation, Center Eugene Marquis |
| NCT07269158 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2025 | Yonsei University |
| NCT07221253 | Phase 3 | Dec 31, 2025 | AstraZeneca |
| NCT07196384 | Phase 1 | Dec 15, 2025 | University of Groningen |
| NCT07195695 | Phase 3 | Dec 5, 2025 | Boehringer Ingelheim |
| NCT06769126 | Phase 2 | Dec 1, 2025 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07229625 | Phase 3 | Nov 30, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT07172412 | Phase 2 | Nov 30, 2025 | Tianjin Medical University |
| NCT06904170 | Phase 2/Phase 3 (Phase 3) | Nov 30, 2025 | AstraZeneca, Center Eugene Marquis, UNICANCER |
| NCT07174570 | Phase 2 | Nov 28, 2025 | Emory University, National Cancer Institute (NCI) |
| NCT07166406 | Phase 3 | Nov 27, 2025 | NRG Oncology |
| NCT07107750 | Phase 1 | Oct 31, 2025 | Curis, Washington University in St. Louis |
| NCT07175441 | Phase 2 | Oct 31, 2025 | Riboscience, LLC. |
| NCT06954480 | Phase 2 | Oct 27, 2025 | AstraZeneca, University of London |
| NCT06880523 | Phase 2 | Oct 21, 2025 | AstraZeneca, Canadian Cancer Trials Group, Fondazione Giovanni Pascale |
| NCT07111546 | Phase 2 | Oct 20, 2025 | Fudan University, Nanjing Leads Biolabs Co.,Ltd |
| NCT06994299 | Phase 2 | Oct 1, 2025 | Cornell University |
Organizations
Research & Development (455)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 339 | 110 | 5 | 2013 |
| National Cancer Institute (NCI) | Government | 61 | 26 | 4 | 2014 |
| MedImmune | For profit | 54 | 25 | 2 | 2012 |
| University of Texas at Houston | Academic/Hospital | 34 | 25 | 3 | 2014 |
| University of Toronto | Academic/Hospital | 20 | 10 | 3 | 2015 |
| Celgene | For profit | 19 | 10 | 2 | 2015 |
| Harvard University | Academic/Hospital | 18 | 10 | 3 | 2015 |
| Seoul National University | Academic/Hospital | 17 | 12 | 3 | 2014 |
| Canadian Cancer Trials Group | Academic/Hospital | 16 | 15 | 3 | 2014 |
| Cornell University | Academic/Hospital | 15 | 11 | 2 | 2013 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 12 | 10 | 4 | 2020 |
| Sungkyunkwan University | Academic/Hospital | 12 | 8 | 1 | 2016 |
| Johns Hopkins University | Academic/Hospital | 11 | 7 | 3 | 2017 |
| Daiichi Sankyo | For profit | 10 | 1 | 3 | 2020 |
| Institut Gustave Roussy | Academic/Hospital | 10 | 5 | 3 | 2014 |
| Yonsei University | Academic/Hospital | 10 | 9 | 1 | 2016 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 9 | 7 | 2 | 2017 |
| UNICANCER | Academic/Hospital | 9 | 8 | 2 | 2014 |
| Cancer Research Institute | Academic/Hospital | 8 | 0 | 2 | 2013 |
| Hoosier Cancer Research Network | Academic/Hospital | 8 | 5 | 1 | 2017 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AstraZeneca | For profit | MKTG | May 1, 2017 |
| AstraZeneca | For profit | NDA | May 1, 2017 |