CLINICAL TRIALS PROFILE FOR DURVALUMAB

All Clinical Trials for Durvalumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01693562 ↗	A Phase 1/2 Study to Evaluate MEDI4736	Completed	MedImmune LLC	Phase 1/Phase 2	2012-09-05	This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.
NCT01975831 ↗	A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab	Completed	Cancer Research Institute, New York City	Phase 1	2013-12-19	This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed standard treatment. The primary study objective was to determine the maximum tolerated dose (MTD) and safety profile of the durvalumab and tremelimumab combination. Secondary objectives were to evaluate the pharmacokinetics (PK) and immunogenicity of durvalumab and tremelimumab, and the antitumor activity (tumor response, progression-free survival [PFS], and overall survival [OS]) of the durvalumab and tremelimumab combination. (Note: Collection of PK and immunogenicity samples was removed by amendment; analysis was not done.) Exploratory objectives were to evaluate the biological activity of the durvalumab and tremelimumab combination.
NCT01975831 ↗	A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab	Completed	MedImmune LLC	Phase 1	2013-12-19	This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed standard treatment. The primary study objective was to determine the maximum tolerated dose (MTD) and safety profile of the durvalumab and tremelimumab combination. Secondary objectives were to evaluate the pharmacokinetics (PK) and immunogenicity of durvalumab and tremelimumab, and the antitumor activity (tumor response, progression-free survival [PFS], and overall survival [OS]) of the durvalumab and tremelimumab combination. (Note: Collection of PK and immunogenicity samples was removed by amendment; analysis was not done.) Exploratory objectives were to evaluate the biological activity of the durvalumab and tremelimumab combination.

Clinical Trial Conditions for Durvalumab

Condition Name

Condition Name for Durvalumab
Intervention	Trials
Non-Small Cell Lung Cancer	44
Hepatocellular Carcinoma	31
Breast Cancer	26

Condition MeSH

Condition MeSH for Durvalumab
Intervention	Trials
Lung Neoplasms	161
Carcinoma, Non-Small-Cell Lung	159
Carcinoma	115

Clinical Trial Locations for Durvalumab

Trials by Country

Trials by Country for Durvalumab
Location	Trials
Canada	275
Japan	95
United Kingdom	94
Brazil	66
Taiwan	62

Trials by US State

Trials by US State for Durvalumab
Location	Trials
New York	141
Texas	127
California	119
Florida	96
Pennsylvania	82

Clinical Trial Progress for Durvalumab

Clinical Trial Phase

Clinical Trial Phase for Durvalumab
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	19
PHASE2	76

Clinical Trial Status

Clinical Trial Status for Durvalumab
Clinical Trial Phase	Trials
Recruiting	316
Active, not recruiting	121
Not yet recruiting	121

Clinical Trial Sponsors for Durvalumab

Sponsor Name

Sponsor Name for Durvalumab
Sponsor	Trials
AstraZeneca	313
National Cancer Institute (NCI)	52
MedImmune LLC	37

Sponsor Type

Sponsor Type for Durvalumab
Sponsor	Trials
Other	774
Industry	533
NIH	53

Durvalumab: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 6, 2026

What is the current status of durvalumab clinical development?

Durvalumab, marketed as Imfinzi by AstraZeneca, is a monoclonal antibody targeting PD-L1. It is approved for various cancers, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, and cervical cancer.

Clinical trial landscape (as of Q1 2023)

Trial Phase	Number of Trials	Major Indications	Notable Trials	Status
Phase 3	15	NSCLC, SCLC, Bladder, Cervical	PACIFIC (lung), CASPIAN (SCLC), DANUBE (bladder)	Ongoing or completed but not yet published results
Phase 2	20	Melanoma, HCC, Other	CONCUR (for melanoma), LOTUS (for HCC)	Recruiting, Active, or Completed
Phase 1/2	10	Rare cancers, combinations	Trials combining durvalumab with chemotherapy or targeted therapies	Ongoing; focus on combination therapies

Recent clinical results

• PACIFIC trial: Confirmed durvalumab improves progression-free survival (PFS) in stage III NSCLC after chemoradiation.
• CASPIAN trial: Demonstrated statistically significant overall survival (OS) benefit in ES-SCLC when combined with chemotherapy.
• DANUBE trial: Failed to meet primary endpoints in bladder cancer, leading to reevaluation of indications.

Regulatory updates

• FDA (June 2022): Approved durvalumab for extensive-stage SCLC in combination with chemotherapy.
• EMA (March 2021): Approved for NSCLC and SCLC.
• Japan (Nov 2020): Approved for NSCLC.

Market size, competition, and growth drivers

Current market valuation

Cancer Type	Market Value (USD bn, 2022)	Expected CAGR (2023-2028)	Key Competitors
NSCLC	4.5	8.2%	Pembrolizumab (Keytruda), atezolizumab (Tecentriq)
SCLC	2.0	9.0%	Pembrolizumab, nivolumab
Bladder Cancer	1.5	7.5%	Atezolizumab, nivolumab
Other indications	1.0	10.0%	Investigational, biosimilars

Market growth drivers

• Rising cancer incidence globally.
• Expansion of indications via clinical trials.
• Increasing acceptance of immunotherapy.
• Strategic collaborations and licensing agreements.

Competitive landscape

Durvalumab faces competition primarily from pembrolizumab (Keytruda), atezolizumab (Tecentriq), and nivolumab (Opdivo). Penetration varies by indication and region.

Market projections (2023–2028)

Year	Global market size (USD bn)	CAGR	Key factors influencing growth
2023	8.0	—	Ongoing approvals, pipeline development
2024	9.2	14.8%	Expanded label indications, new trial results
2025	10.5	14.1%	Approvals in additional markets, combination therapies
2026	12.0	13.3%	Increased healthcare adoption, access expansion
2027	13.8	14.0%	Market saturation in core indications
2028	15.7	13.8%	Entry into new indications, biosimilar competition

Key assumptions:

• Continued growth in immunotherapy adoption.
• Slight price erosion due to biosimilars.
• Stable regulatory environment.

Regulatory and commercialization outlook

AstraZeneca is pursuing additional regulatory pathways in Europe, Asia, and Latin America. The company is actively expanding the scope of durvalumab’s use beyond approved indications through ongoing clinical trials.

Key challenges

• Limited success in some indications (e.g., bladder cancer DANUBE trial).
• Competition from other PD-1/PD-L1 inhibitors.
• Potential for biosimilar entry by 2030.

---

Key Takeaways

• Durvalumab remains a leading PD-L1 inhibitor with approved uses in NSCLC, SCLC, and other cancers.
• The clinical pipeline is robust, focusing on combination therapies and new indications.
• The global immunotherapy market is projected to grow at over 13% annually, driven by expanding indications and acceptance.
• Competition with pembrolizumab and atezolizumab is intense; market share is influenced heavily by clinical outcomes and regulatory approvals.
• Biosimilar threat and pricing pressures will shape profitability over the next five years.

---

FAQs

1. What are durvalumab’s main approved indications?
NSCLC (stage III), SCLC (extensive stage), and certain urothelial cancers.

2. How does durvalumab compare to competitor drugs?
It has similar efficacy and safety profiles but faces stiff competition from pembrolizumab and atezolizumab, especially in terms of market share and indication breadth.

3. What are the most promising upcoming clinical trials?
Trials combining durvalumab with chemotherapy, targeted agents, or novel immunotherapies aim to expand its use.

4. What risks could impact durvalumab’s market penetration?
Failure to demonstrate superior efficacy in new indications, biosimilar competition, and regulatory hurdles.

5. Which regions represent growth opportunities for durvalumab?
Asia-Pacific, Latin America, and emerging markets, where approval processes are progressing but market penetration remains low.

---

References

[1] AstraZeneca. (2022). Imfinzi Prescribing Information.
[2] ClinicalTrials.gov. (2023). Durvalumab trials.
[3] IQVIA. (2022). Oncology Market Overview.
[4] Grand View Research. (2022). Cancer Immunotherapy Market Size.
[5] EMA. (2021). European public assessment reports for durvalumab.