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Durvalumab (Regimen 2)
Durvalumab (Regimen 2) is a PD-L1 inhibitor Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy, Metastatic or unresectable locally advanced urothelial carcinoma, Biliary tract cancer.
Durvalumab is a PD-L1 inhibitor that blocks the interaction between PD-L1 on tumor cells and PD-1/PD-L2 on immune cells, thereby restoring anti-tumor immune responses.
Durvalumab is a PD-L1 inhibitor that blocks the interaction between PD-L1 on tumor cells and PD-1/PD-L2 on immune cells, thereby restoring anti-tumor immune responses. Used for Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy, Metastatic or unresectable locally advanced urothelial carcinoma, Biliary tract cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Durvalumab (Regimen 2) |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Durvalumab binds to programmed death ligand 1 (PD-L1) expressed on tumor cells and immune cells, preventing engagement with PD-1 and PD-L2 receptors on T cells. This blockade removes the inhibitory signal that tumors use to evade immune surveillance, allowing T cells to recognize and attack cancer cells. Regimen 2 typically refers to a specific dosing or combination schedule in clinical trials.
Approved indications
- Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy
- Metastatic or unresectable locally advanced urothelial carcinoma
- Biliary tract cancer
Common side effects
- Fatigue
- Pneumonitis
- Diarrhea
- Nausea
- Decreased appetite
- Immune-mediated hepatitis
- Immune-mediated colitis
Key clinical trials
- Durvalumab as Consolidation for Patients LS-SCLC (PHASE2)
- IIT2025-03-YANG-LIFT-HCC (PHASE2)
- 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 (PHASE3)
- 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) (PHASE1, PHASE2)
- Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (PHASE3)
- SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety (PHASE2)
- Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (PHASE3)
- Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Durvalumab (Regimen 2) CI brief — competitive landscape report
- Durvalumab (Regimen 2) updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Durvalumab (Regimen 2)
What is Durvalumab (Regimen 2)?
How does Durvalumab (Regimen 2) work?
What is Durvalumab (Regimen 2) used for?
Who makes Durvalumab (Regimen 2)?
What drug class is Durvalumab (Regimen 2) in?
What development phase is Durvalumab (Regimen 2) in?
What are the side effects of Durvalumab (Regimen 2)?
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Related
- Drug class: All PD-L1 inhibitor drugs
- Target: All drugs targeting PD-L1
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy
- Indication: Drugs for Metastatic or unresectable locally advanced urothelial carcinoma
- Indication: Drugs for Biliary tract cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing