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Adjuvant durvalumab
Adjuvant durvalumab is a PD-L1 inhibitor Small molecule drug developed by ETOP IBCSG Partners Foundation. It is currently in Phase 3 development for Adjuvant treatment of stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy, Adjuvant treatment of resected stage II-III gastric or gastroesophageal junction adenocarcinoma.
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 Adjuvant treatment of stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy, Adjuvant treatment of resected stage II-III gastric or gastroesophageal junction adenocarcinoma.
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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.
| 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 | Adjuvant durvalumab |
|---|---|
| Sponsor | ETOP IBCSG Partners Foundation |
| 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 reverses tumor-mediated immune suppression, allowing cytotoxic T lymphocytes to recognize and eliminate cancer cells. In the adjuvant setting, durvalumab is used post-operatively to reduce recurrence risk in early-stage disease.
Approved indications
- Adjuvant treatment of stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy
- Adjuvant treatment of resected stage II-III gastric or gastroesophageal junction adenocarcinoma
Common side effects
- Fatigue
- Pneumonitis
- Diarrhea
- Nausea
- Rash
- Immune-mediated hepatitis
- Immune-mediated colitis
Key clinical trials
- Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
- Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer (PHASE3)
- Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC (PHASE2)
- Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment (PHASE3)
- 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) (PHASE3)
- A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. (PHASE3)
- Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (PHASE3)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (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:
- Adjuvant durvalumab CI brief — competitive landscape report
- Adjuvant durvalumab updates RSS · CI watch RSS
- ETOP IBCSG Partners Foundation portfolio CI
Frequently asked questions about Adjuvant durvalumab
What is Adjuvant durvalumab?
How does Adjuvant durvalumab work?
What is Adjuvant durvalumab used for?
Who makes Adjuvant durvalumab?
What drug class is Adjuvant durvalumab in?
What development phase is Adjuvant durvalumab in?
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What does Adjuvant durvalumab target?
Related
- Drug class: All PD-L1 inhibitor drugs
- Target: All drugs targeting PD-L1
- Manufacturer: ETOP IBCSG Partners Foundation — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy
- Indication: Drugs for Adjuvant treatment of resected stage II-III gastric or gastroesophageal junction adenocarcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing