Durvalumab
drugOn this page
Also known as ImfinziMEDI-4736MEDI4736
Summary
Durvalumab (CHEMBL3301587) is an approved antibody (ATC L01FF03); indicated across 97 conditions including neoplasm and non-small cell lung carcinoma; with CIViC clinical evidence for 10 variant-indication associations (e.g. CD274 Amplification in triple-receptor negative breast cancer).
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L01FF03
- Indications: 97 conditions
- Clinical trials: 719
- Precision-oncology evidence (CIViC): 10 variant–indication associations
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL3301587 |
| Name | Durvalumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L01FF03 |
Also known as: Durvalumab, Imfinzi, MEDI-4736, MEDI4736, DURVALUMAB
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
97 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| non-small cell lung carcinoma | 4 | MONDO:0005233 | EFO:0003060 |
| small cell lung carcinoma | 4 | MONDO:0008433 | EFO:0000702 |
| breast carcinoma | 3 | MONDO:0004989 | EFO:0000305 |
| breast neoplasm | 3 | MONDO:0021100 | EFO:0003869 |
| head and neck squamous cell carcinoma | 3 | MONDO:0010150 | EFO:0000181 |
| ovarian carcinoma | 3 | MONDO:0005140 | EFO:0001075 |
| squamous cell lung carcinoma | 3 | MONDO:0005097 | EFO:0000708 |
| mesothelioma | 3 | MONDO:0005065 | EFO:0000588 |
| hepatocellular carcinoma | 3 | MONDO:0007256 | EFO:0000182 |
| urinary bladder neoplasm | 3 | MONDO:0004987 | EFO:0000294 |
| clear cell renal carcinoma | 3 | MONDO:0005005 | EFO:0000349 |
| renal cell carcinoma | 3 | MONDO:0005086 | EFO:0000681 |
| squamous cell carcinoma | 3 | MONDO:0005096 | EFO:0000707 |
| biliary tract neoplasm | 3 | MONDO:0005304 | EFO:0003891 |
| esophageal squamous cell carcinoma | 3 | MONDO:0005580 | EFO:0005922 |
| oropharynx cancer | 3 | MONDO:0004608 | EFO:1001931 |
| urothelial carcinoma | 3 | MONDO:0040679 | EFO:0008528 |
| malignant pleural mesothelioma | 3 | MONDO:0005112 | EFO:0000770 |
| endometrium neoplasm | 3 | MONDO:0021251 | EFO:0004230 |
| ovarian cancer | 3 | MONDO:0008170 | MONDO:0008170 |
| lung neoplasm | 3 | MONDO:0021117 | MONDO:0008903 |
| papillary renal cell carcinoma | 3 | MONDO:0017884 | EFO:0000640 |
| lung carcinoma | 3 | MONDO:0005138 | EFO:0001071 |
| gastric adenocarcinoma | 2 | MONDO:0005036 | EFO:0000503 |
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| diffuse large B-cell lymphoma | 2 | MONDO:0018905 | EFO:0000403 |
| glioblastoma | 2 | MONDO:0018177 | EFO:0000519 |
| plasma cell myeloma | 2 | MONDO:0009693 | EFO:0001378 |
| exocrine pancreatic carcinoma | 2 | MONDO:0005192 | EFO:0002618 |
| myelodysplastic syndrome | 2 | MONDO:0018881 | EFO:0000198 |
| acute myeloid leukemia | 2 | MONDO:0018874 | EFO:0000222 |
| adenocarcinoma | 2 | MONDO:0004970 | EFO:0000228 |
| clear cell adenocarcinoma | 2 | MONDO:0005004 | EFO:0000348 |
| germ cell tumor | 2 | MONDO:0005040 | EFO:0000514 |
| lymphoma | 2 | MONDO:0005062 | EFO:0000574 |
| sarcoma | 2 | MONDO:0005089 | EFO:0000691 |
| lung large cell carcinoma | 2 | MONDO:0003050 | EFO:0003050 |
| upper aerodigestive tract neoplasm | 2 | MONDO:0005398 | EFO:0004284 |
| non-Hodgkin lymphoma | 2 | MONDO:0018908 | EFO:0005952 |
| head and neck cancer | 2 | MONDO:0005627 | EFO:0006859 |
| rectal cancer | 2 | MONDO:0006519 | EFO:1000657 |
| colorectal carcinoma | 2 | MONDO:0024331 | EFO:1001951 |
| thyroid gland follicular carcinoma | 2 | MONDO:0005034 | EFO:0000501 |
| lung adenocarcinoma | 2 | MONDO:0005061 | EFO:0000571 |
| thyroid gland papillary carcinoma | 2 | MONDO:0005075 | EFO:0000641 |
| prostate adenocarcinoma | 2 | MONDO:0005082 | EFO:0000673 |
| triple-negative breast carcinoma | 2 | MONDO:0005494 | EFO:0005537 |
| fallopian tube carcinoma | 2 | MONDO:0006206 | EFO:1000251 |
| colorectal adenocarcinoma | 2 | MONDO:0005008 | EFO:0000365 |
| angiosarcoma | 2 | MONDO:0016982 | EFO:0003968 |
| lung neuroendocrine neoplasm | 2 | MONDO:0005454 | EFO:0005220 |
| cholangiocarcinoma | 2 | MONDO:0019087 | EFO:0005221 |
| intrahepatic cholangiocarcinoma | 2 | MONDO:0003210 | EFO:1001961 |
| soft tissue sarcoma | 2 | MONDO:0018078 | EFO:1001968 |
| gastric neoplasm | 2 | MONDO:0021085 | MONDO:0001056 |
| seminoma | 2 | MONDO:0003001 | MONDO:0003001 |
| dysgerminoma | 2 | MONDO:0003002 | MONDO:0003002 |
| bile duct neoplasm | 2 | MONDO:0021662 | MONDO:0003059 |
| anus neoplasm | 2 | MONDO:0003046 | MONDO:0003199 |
| oral cavity squamous cell carcinoma | 2 | MONDO:0004958 | EFO:0000199 |
| colonic neoplasm | 2 | MONDO:0005401 | MONDO:0021063 |
| inflammatory breast carcinoma | 2 | MONDO:0006804 | EFO:1000984 |
| prostate carcinoma | 2 | MONDO:0005159 | EFO:0001663 |
| pancreatic neoplasm | 2 | MONDO:0021040 | EFO:0003860 |
| chronic hepatitis B virus infection | 2 | MONDO:0005366 | EFO:0004239 |
| gallbladder neoplasm | 2 | MONDO:0021253 | EFO:0004606 |
| female reproductive organ cancer | 2 | MONDO:0001416 | EFO:1001331 |
| gallbladder carcinoma | 2 | MONDO:0003220 | EFO:1001956 |
| neuroendocrine carcinoma | 2 | MONDO:0002120 | MONDO:0002120 |
| pancreatic ductal adenocarcinoma | 2 | MONDO:0005184 | MONDO:0005184 |
| colorectal neoplasm | 2 | MONDO:0005335 | MONDO:0005575 |
| rectal neoplasm | 2 | MONDO:0002165 | MONDO:0044937 |
| primary myelofibrosis | 1 | MONDO:0009692 | EFO:0002430 |
| B-cell chronic lymphocytic leukemia | 1 | MONDO:0004948 | EFO:0000095 |
| acquired polycythemia vera | 1 | MONDO:0009891 | EFO:0002429 |
| primary cutaneous T-cell non-Hodgkin lymphoma | 1 | MONDO:0000607 | EFO:0002913 |
| plasmacytoma | 1 | MONDO:0005615 | EFO:0006738 |
| metastatic neoplasm | 1 | MONDO:0024883 | EFO:0009709 |
| follicular lymphoma | 1 | MONDO:0018906 | MONDO:0018906 |
| skin neoplasm | 1 | MONDO:0002531 | MONDO:0002898 |
16 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 719.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 380 |
| PHASE1 | 125 |
| PHASE1/PHASE2 | 88 |
| PHASE3 | 87 |
| Not specified | 20 |
| EARLY_PHASE1 | 9 |
| PHASE4 | 5 |
| PHASE2/PHASE3 | 5 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06031233 | PHASE4 | RECRUITING | Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie |
| NCT06908070 | PHASE4 | RECRUITING | Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab |
| NCT04078152 | PHASE4 | COMPLETED | Durvalumab Long-Term Safety and Efficacy Study |
| NCT04356222 | PHASE4 | UNKNOWN | Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis |
| NCT04416633 | PHASE4 | COMPLETED | Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC |
| NCT02273375 | PHASE3 | ACTIVE_NOT_RECRUITING | Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC |
| NCT02453282 | PHASE3 | ACTIVE_NOT_RECRUITING | Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC) |
| NCT02516241 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer |
| NCT02542293 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) |
| NCT03003962 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL) |
| NCT03043872 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) |
| NCT03164616 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). |
| NCT03288532 | PHASE3 | RECRUITING | Renal Adjuvant MultiPle Arm Randomised Trial |
| NCT03298451 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma |
| NCT03519971 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer |
| NCT03528694 | PHASE3 | ACTIVE_NOT_RECRUITING | Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer |
| NCT03682068 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer |
| NCT03703297 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy |
| NCT03706690 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients |
| NCT03732677 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC |
| NCT03737643 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients |
| NCT03778957 | PHASE3 | ACTIVE_NOT_RECRUITING | A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma |
| NCT03800134 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer |
| NCT03833154 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation |
| NCT03847428 | PHASE3 | ACTIVE_NOT_RECRUITING | Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment |
| NCT03875235 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) |
| NCT04092283 | PHASE3 | ACTIVE_NOT_RECRUITING | Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer |
| NCT04116047 | PHASE3 | ACTIVE_NOT_RECRUITING | CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC) |
| NCT04269200 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer |
| NCT04380636 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) |
| NCT04465968 | PHASE3 | NOT_YET_RECRUITING | Efficacy and Safety of CRT, Durvalumab and Surgery for SST |
| NCT04550260 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC |
| NCT04585490 | PHASE3 | RECRUITING | Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC |
| NCT04592913 | PHASE3 | ACTIVE_NOT_RECRUITING | Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer |
| NCT04597671 | PHASE3 | ACTIVE_NOT_RECRUITING | Durvalumab and Low-dose PCI vs Durvalumab and Observation in Radically Treated Patients With Stage III NSCLC (NVALT28) |
| NCT04628767 | PHASE2/PHASE3 | RECRUITING | Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer |
| NCT04637594 | PHASE3 | ACTIVE_NOT_RECRUITING | Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy |
| NCT04960709 | PHASE3 | ACTIVE_NOT_RECRUITING | Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin |
| NCT05043090 | PHASE3 | ACTIVE_NOT_RECRUITING | Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC |
| NCT05170204 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) |
Clinical evidence (CIViC)
Variant × indication × effect (10 predictive associations from 10 curated evidence items):
| Variant | Indication | Effect | Therapy | Level | CIViC |
|---|---|---|---|---|---|
| CD274 Amplification | Triple-receptor Negative Breast Cancer | Sensitivity/Response | Durvalumab | CIViC B | EID12054 |
| CD274 Expression | Lung Non-small Cell Carcinoma | Sensitivity/Response | Atezolizumab + Avelumab + Pembrolizumab + Nivolumab + Durvalumab | CIViC B | EID4857 |
| PBRM1 Loss-of-function | Renal Cell Carcinoma | Sensitivity/Response | Atezolizumab + Durvalumab | CIViC B | EID7537 |
| TMB High | Colorectal Cancer | Sensitivity/Response | Tremelimumab + Durvalumab | CIViC B | EID12042 |
| TMB High | Lung Non-small Cell Carcinoma | Sensitivity/Response | Durvalumab + Tremelimumab | CIViC B | EID12799 |
| TMB High | Head And Neck Squamous Cell Carcinoma | Sensitivity/Response | Durvalumab | CIViC B | EID12850 |
| MSH2 Loss | Transitional Cell Carcinoma | Sensitivity/Response | Anti-PD-1 Monoclonal Antibody MEDI0680 + Durvalumab | CIViC C | EID1877 |
| MSH6 LOSS | Transitional Cell Carcinoma | Sensitivity/Response | Anti-PD-1 Monoclonal Antibody MEDI0680 + Durvalumab | CIViC C | EID1878 |
| EGFR E746_A750del | Lung Non-small Cell Carcinoma | Sensitivity/Response | Durvalumab | CIViC D | EID2518 |
| CD274 v242 | Lung Non-small Cell Carcinoma | Resistance | Durvalumab + Atezolizumab + Avelumab | CIViC E | EID9695 |
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: neoplasm, non-small cell lung carcinoma, small cell lung carcinoma, breast carcinoma, breast neoplasm, head and neck squamous cell carcinoma, ovarian carcinoma, squamous cell lung carcinoma, mesothelioma, hepatocellular carcinoma, urinary bladder neoplasm, clear cell renal carcinoma, renal cell carcinoma, squamous cell carcinoma, biliary tract neoplasm, esophageal squamous cell carcinoma, oropharynx cancer, urothelial carcinoma, malignant pleural mesothelioma, endometrium neoplasm, ovarian cancer, lung neoplasm, papillary renal cell carcinoma, lung carcinoma, triple-negative breast carcinoma, colorectal carcinoma, transitional cell carcinoma