Durvalumab
Also known as Imfinzi
ASTRAZENECA PLC AZN · Biliary Tract Cancer; Breast Cancer; Hepatocellular Carcinoma; Esophagogastric Junction; Non-Small Cell Lung Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
30
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761069,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Biliary Tract Cancer; Breast Cancer; Hepatocellular Carcinoma; Esophagogastric Junction; Non-Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761069 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761069 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 14 May 201830 linked trials
- Filed Completed
- Approved Current stageFirst approval 1 May 2017
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Durvalumab. Editors add each one with its source.
Filed application
No filed application is on record for Durvalumab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Durvalumab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07877818ClinicalTrials.gov record for NCT07877818 (opens in a new tab) | A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC. | Phase 3 | Not yet recruiting | 140 (estimated) | 1 Nov 2029 (estimated) | No |
| NCT07720284ClinicalTrials.gov record for NCT07720284 (opens in a new tab)TU-04 | An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC | Phase 3 | Recruiting | 915 (estimated) | 11 Sep 2030 (estimated) | No |
| NCT07221253ClinicalTrials.gov record for NCT07221253 (opens in a new tab)AB02 | A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) | Phase 3 | Recruiting | 1,100 (estimated) | 31 Jul 2029 (estimated) | No |
| NCT06992609ClinicalTrials.gov record for NCT06992609 (opens in a new tab)ALBORAN | Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer. | Phase 3 | Active, not recruiting | 71 (actual) | 30 Jun 2029 (estimated) | No |
| NCT06746116ClinicalTrials.gov record for NCT06746116 (opens in a new tab)DUoENDE | A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Advanced or Recurrent Endometrial Cancer in Spain | Phase 3 | Active, not recruiting | 45 (actual) | 30 Nov 2028 (estimated) | No |
| NCT06467357ClinicalTrials.gov record for NCT06467357 (opens in a new tab)DESTINY-BTC01 | Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer | Phase 3 | Recruiting | 620 (estimated) | 12 Jun 2028 (estimated) | No |
| NCT06103864ClinicalTrials.gov record for NCT06103864 (opens in a new tab) | A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) | Phase 3 | Recruiting | 625 (estimated) | 28 Jul 2027 (estimated) | No |
Publications listing NCT06103864 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT06112379ClinicalTrials.gov record for NCT06112379 (opens in a new tab) | A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer | Phase 3 | Active, not recruiting | 1,902 (actual) | 20 Nov 2028 (estimated) | No |
Publications listing NCT06112379 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05771480ClinicalTrials.gov record for NCT05771480 (opens in a new tab)TOURMALINE | Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) | Phase 3 | Active, not recruiting | 142 (actual) | 2 Oct 2025 (actual) | No |
Publications listing TOURMALINE (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05943106ClinicalTrials.gov record for NCT05943106 (opens in a new tab)PATAPSCO | BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants | Phase 3 | Active, not recruiting | 100 (actual) | 16 Jun 2025 (actual) | No |
| NCT05924880ClinicalTrials.gov record for NCT05924880 (opens in a new tab)TopDouble | A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC) | Phase 3 | Completed | 116 (actual) | 7 Feb 2025 (actual) | No |
| NCT05883644ClinicalTrials.gov record for NCT05883644 (opens in a new tab)SIERRA | Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC) | Phase 3 | Active, not recruiting | 111 (actual) | 30 Mar 2026 (actual) | No |
Publications listing SIERRA (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05557838ClinicalTrials.gov record for NCT05557838 (opens in a new tab)TREMENDOUS | Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC | Phase 3 | Active, not recruiting | 214 (actual) | 30 Sep 2026 (estimated) | No |
| NCT05687266ClinicalTrials.gov record for NCT05687266 (opens in a new tab)AVANZAR | Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations | Phase 3 | Active, not recruiting | 1,350 (actual) | 1 Nov 2027 (estimated) | No |
| NCT05629585ClinicalTrials.gov record for NCT05629585 (opens in a new tab) | A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03) | Phase 3 | Active, not recruiting | 1,174 (actual) | 1 Sep 2027 (estimated) | No |
Publications listing NCT05629585 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05450692ClinicalTrials.gov record for NCT05450692 (opens in a new tab)LATIFY | A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy | Phase 3 | Active, not recruiting | 594 (actual) | 6 Oct 2025 (actual) | No |
| NCT05303532ClinicalTrials.gov record for NCT05303532 (opens in a new tab)ROSY-D | Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab | Phase 3 | Enrolling by invitation | 214 (estimated) | 31 Dec 2026 (estimated) | No |
| NCT05301842ClinicalTrials.gov record for NCT05301842 (opens in a new tab)EMERALD-3 | Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC | Phase 3 | Active, not recruiting | 760 (actual) | 23 Feb 2026 (actual) | No |
Publications listing EMERALD-3 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05211895ClinicalTrials.gov record for NCT05211895 (opens in a new tab)PACIFIC-8 | A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC | Phase 3 | Active, not recruiting | 791 (actual) | 10 Aug 2026 (actual) | No |
| NCT05221840ClinicalTrials.gov record for NCT05221840 (opens in a new tab)PACIFIC-9 | A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | Phase 3 | Active, not recruiting | 1,051 (actual) | 30 Sep 2026 (estimated) | No |
Publications listing PACIFIC-9 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05043090ClinicalTrials.gov record for NCT05043090 (opens in a new tab)SAMETA | Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC | Phase 3 | Active, not recruiting | 148 (actual) | 31 Dec 2025 (actual) | No |
Publications listing SAMETA (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04960709ClinicalTrials.gov record for NCT04960709 (opens in a new tab)VOLGA | 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 | Phase 3 | Active, not recruiting | 712 (actual) | 2 Mar 2026 (actual) | No |
| NCT04592913ClinicalTrials.gov record for NCT04592913 (opens in a new tab) | Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer | Phase 3 | Active, not recruiting | 957 (actual) | 20 Dec 2024 (actual) | No |
Publications listing NCT04592913 (5), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04550260ClinicalTrials.gov record for NCT04550260 (opens in a new tab)KUNLUN | Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC | Phase 3 | Active, not recruiting | 640 (actual) | 30 Jun 2027 (estimated) | No |
| NCT04269200ClinicalTrials.gov record for NCT04269200 (opens in a new tab)DUO-E | Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer | Phase 3 | Active, not recruiting | 805 (actual) | 8 Jul 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04269200 (opens in a new tab) |
Posted results on ClinicalTrials.gov for DUO-E
Serious adverse events (Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months): Global Cohort - SoC 73 of 236; Global Cohort - SoC + Durvalumab 73 of 235; Global Cohort - SoC + Durvalumab + Olaparib 85 of 238; China Cohort - SoC 14 of 44; China Cohort - SoC + Durvalumab 8 of 41; China Cohort - SoC + Durvalumab + Olaparib 19 of 41 Source: ClinicalTrials.gov results for NCT04269200 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing DUO-E (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03847428ClinicalTrials.gov record for NCT03847428 (opens in a new tab)EMERALD-2 | Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment | Phase 3 | Completed | 908 (actual) | 15 May 2026 (actual) | No |
| NCT03833154ClinicalTrials.gov record for NCT03833154 (opens in a new tab)PACIFIC-4 | 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 | Phase 3 | Active, not recruiting | 724 (actual) | 31 Oct 2028 (estimated) | No |
| NCT03737643ClinicalTrials.gov record for NCT03737643 (opens in a new tab)DUO-O | Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients | Phase 3 | Active, not recruiting | 1,407 (actual) | 17 Mar 2025 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03737643 (opens in a new tab) |
Posted results on ClinicalTrials.gov for DUO-O
Serious adverse events (For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.): Global Non-tBRCAm: SoC 132 of 376; Global Non-tBRCAm: SoC + Durvalumab 165 of 373; Global Non-tBRCAm: SoC + Durvalumab + Olaparib 152 of 378; Global tBRCAm: SoC + Durvalumab + Olaparib 74 of 153; China Non-tBRCAm: SoC 19 of 40; China Non-tBRCAm: SoC + Durvalumab 17 of 43; China Non-tBRCAm: SoC + Durvalumab + Olaparib 22 of 41 Source: ClinicalTrials.gov results for NCT03737643 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing DUO-O (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03682068ClinicalTrials.gov record for NCT03682068 (opens in a new tab)NILE | Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer | Phase 3 | Active, not recruiting | 1,246 (actual) | 1 Jun 2026 (actual) | No |
Publications listing NILE (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03528694ClinicalTrials.gov record for NCT03528694 (opens in a new tab)POTOMAC | Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer | Phase 3 | Active, not recruiting | 1,018 (actual) | 3 Apr 2025 (actual) | No |
Publications listing POTOMAC (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Imfinzi (EMEA/H/C/004771)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- Marketing authorisation holder
- AstraZeneca AB
- Active substance (INN)
- durvalumab
- ATC code
- L01XC28
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Imfinzi (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
- Positive Overall Survival Results from the Phase III HARMONi-GI1 Trial of Ivonescimab Plus Chemotherapy Versus Durvalumab Plus Chemotherapy in First-Line Biliary Tract Cancer Presented at the ESMO 2026 Presidential Symposium (opens in a new tab)
- IMDELLTRA® IN COMBINATION WITH IMFINZI® REDUCED RISK OF DEATH BY AN UNPRECEDENTED 58% IN FIRST-LINE EXTENSIVE STAGE SMALL CELL LUNG CANCER (opens in a new tab)
Sources
- Drugs@FDA 761069 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07877818 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT07720284 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT07221253 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06992609 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06746116 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06467357 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06103864 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06112379 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05771480 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05943106 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05924880 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05883644 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05557838 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05687266 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05629585 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05450692 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05303532 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05301842 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05211895 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05221840 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05043090 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04960709 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04592913 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04550260 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04269200 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03847428 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03833154 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03737643 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03682068 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03528694 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761069 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.