Data updated: May 26, 2026
IMFINZI (durvalumab)
Programmed Death Ligand-1 Antagonists Genetically Validated
Trial Activity: Growth 291 active trials
Breakthrough Therapy Priority Review Accelerated Approval
Oncology
Approved 2017-05-01
IMFINZI is indicated for the treatment of Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Biliary Tract Cancer.
Development Insights
AstraZeneca conducting 93 trials (17%)
897 indications explored (Broad Platform)
→ non-small cell lung cancer (39 trials)
→ hepatocellular carcinoma (28 trials)
→ breast cancer (21 trials)
15
Indications
--
Phase 3 Trials
10
Priority Reviews
9
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-05-01
- Patent Cliff
- 2031
- Revenue
- $1.7B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IMFINZI Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
26 FDA actions from 2017 to 2025 · 14 indication expansions
What IMFINZI Treats
3 indicationsIMFINZI is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
- Small Cell Lung Cancer
- Biliary Tract Cancer
Source: FDA Label
IMFINZI Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
PD-L1 (Programmed Death-Ligand 1) ligand
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
PD-L2 (Programmed Death-Ligand 2) ligand
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
IMFINZI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
2
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
2
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IMFINZI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IMFINZI treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Brigimadlin BI 907828
Boehringer Ingelheim MDM2 · small-molecule MDM2-p53 inhibitor · 3 Phase 3 trials
Drugs Similar to IMFINZI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
KEYTRUDA
PEMBROLIZUMAB
Merck
Shared indications:
Non-Small Cell Lung CancerBiliary Tract Cancer
TECENTRIQ
ATEZOLIZUMAB
Roche
Shared indications:
Non-Small Cell Lung CancerSmall Cell Lung Cancer
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Clinical Trial Registry
545 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06058377 | NCI-2023-04566 NCI-2023-04566, S2206 | Ph 3 | recruiting | Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer |
| NCT03606967 | NCI-2018-01581 NCI-2018-01581, 10146 | Ph 2 | recruiting | Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer |
| NCT06058663 | MC1943 21-007474 | Ph 1 | recruiting | Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma |
| NCT07012798 | DB-HERO | Ph 2 | recruiting | FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma |
| NCT04628767 | NCI-2020-09850 NCI-2020-09850, EA8192 | Ph 2, Ph 3 | recruiting | Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer |
| NCT06050252 | NCI-2023-07031 NCI-2023-07031, 2024-0230 | Ph 2 | recruiting | Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery |
| NCT06732401 | NCI-2024-10081 NCI-2024-10081, EA5231 | Ph 3 | active not recruiting | Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer |
| NCT06591650 GCND | Huashan010 | Ph 2 | recruiting | Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer |
| NCT04379596 DG-03 | D967LC00001 2019-004483-22 | Ph 2 | recruiting | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) |
| NCT06287775 | NCI-2024-01398 NCI-2024-01398, 10629 | Ph 1, Ph 2 | recruiting | Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer |
| NCT04216290 | NCI-2019-08628 NCI-2019-08628, EA8185 | Ph 2 | active not recruiting | A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial |
| NCT03706690 PACIFIC-5 results posted | D933YC00001 2018-002294-22 | Ph 3 | active not recruiting | A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients |
| NCT03907475 | NCI-2019-01886 NCI-2019-01886, 10292 | Ph 2 | recruiting | Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial |
| NCT06498635 | NCI-2024-05588 NCI-2024-05588, S2414 | Ph 3 | recruiting | Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial |
| NCT05411094 | NCI-2022-04526 NCI-2022-04526, UMCC 2021.037 | Ph 1 | recruiting | Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer |
| NCT06694454 | 10001609 001609-C | Ph 1, Ph 2 | recruiting | Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) |
| NCT04550260 KUNLUN | D910SC00001 2020-001001-22 | Ph 3 | active not recruiting | Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC |
| NCT05198830 | NCI-2021-14403 NCI-2021-14403, CASE1522 | Ph 2 | recruiting | Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer |
| NCT07081633 TREMENDOUS-2 | D419CL00025 | Ph 2 | active not recruiting | Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma |
| NCT04918186 IPROC | I240 | Ph 2 | recruiting | Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer |
| NCT06890598 SUNRAY-02 | 18763 2024-512302-25-00, J3M-MC-JZQH | Ph 3 | recruiting | Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer |
| NCT03819465 MAGELLAN | D933IC00001 2018-001748-74 | Ph 1 | active not recruiting | A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC |
| NCT06667908 CONVERGE | 90301900NSC2001 90301900NSC2001, 2024-518276-32-00 | Ph 2 | recruiting | A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC) |
| NCT04716946 | 20-415 | Ph 2 | active not recruiting | Treating Early-stage Non-Small Cell Lung Cancer With Durvalumab and Radiation Therapy |
| NCT03459846 BAYOU results posted | D933IC00003 2017-004556-27 | Ph 2 | active not recruiting | A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) |
| NCT06282575 | JZP598-302 2023-508219-21-00 | Ph 3 | recruiting | Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer |
| NCT03601455 | 17-001894 NCI-2018-01415, 17-001894 | Ph 2 | active not recruiting | Radiation Therapy and Durvalumab With or Without Tremelimumab in Treating Participants With Unresectable, Locally Advanced, or Metastatic Bladder Cancer |
| NCT05092412 | ESR-20-20849 | Ph 2 | active not recruiting | Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC |
| NCT06290505 PALEO | PALEO | Ph 2 | recruiting | A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study |
| NCT06728410 | HCRN-GI23-621 | Ph 2 | recruiting | A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement |
| NCT06564623 | J2477 IRB00416341 | Ph 1 | recruiting | Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC) |
| NCT04116047 CompARE | RG 14-093 2014-003389-26, ISRCTN41478539 | Ph 3 | active not recruiting | CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC) |
| NCT05154994 RESOLVE | HCI143952 NCI-2021-12484, HCI143952 | Ph 1 | active not recruiting | Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma |
| NCT07531095 DeLLphi-313 | 20250114 2025-522888-15-00 | Ph 1 | recruiting | Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) |
| NCT07146230 SPRINT 2 | 2024-15810 | Ph 2 | not yet recruiting | The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2 |
| NCT05027425 results posted | UCCC-GI-21-01 | Ph 2 | terminated | Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant |
| NCT02484404 | 150145 15-C-0145 | Ph 1, Ph 2 | active not recruiting | Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can... |
| NCT07195695 | 1479-0032 U1111-1320-6149, 2025-521284-12-00 | Ph 3 | recruiting | Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations |
| NCT06094140 NEO-IMPACT | NEO-IMPACT | Ph 2 | active not recruiting | NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer |
| NCT06441747 | BIL-PPP | Ph 2 | recruiting | Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP) |
| NCT05170204 HORIZON 1 | BO42777 2023-503920-14-00 | Ph 3 | 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) |
| NCT04786093 results posted | STU-2021-0171 | Ph 2 | terminated | Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC |
| NCT07247786 MIGRANT | GECP 24/02_MIGRANT 2025-521251-24-00 | Ph 2 | not yet recruiting | Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT) |
| NCT07122089 IOSPHERE | 2025-3-77-001 2025-A01081-48 | Ph 2 | recruiting | Evaluation of SIRT Followed by Immunotherapy for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis |
| NCT07005128 DeLLphi-312 | 20240178 | Ph 3 | recruiting | A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) |
| NCT07226063 | CASE11225 | Ph 2 | not yet recruiting | Maintenance Zanzalintinib and Durvalumab in Participants With Advanced Hepatocellular Cancer |
| NCT07166406 | NRG-GI012 NCI-2025-05951, NRG-GI012 | Ph 3 | recruiting | Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial |
| NCT03482102 | 17-517 | Ph 2 | active not recruiting | Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer |
| NCT04585490 | IRB-54807 LUN0114, NCI-2021-09500 | Ph 3 | recruiting | Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC |
| NCT03660826 results posted | NCI-2017-01672 NCI-2017-01672, NRG-GY012 | Ph 2 | active not recruiting | Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone |
Showing 50 of 545 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMFINZI FDA Label Details
Indications & Usage
FDA Label (PDF)IMFINZI is indicated for the treatment of Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Biliary Tract Cancer.
Pro Intelligence Preview
Deep insights for IMFINZI
Revenue Insights
- • Q4-2025: $1.7B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • 551 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment