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.
NCT01975831 ↗	A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab	Completed	Ludwig Institute for Cancer Research	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.
NCT01993810 ↗	Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer	Recruiting	National Cancer Institute (NCI)	Phase 3	2014-02-03	This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.
NCT01993810 ↗	Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer	Recruiting	NRG Oncology	Phase 3	2014-02-03	This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

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
Lung Cancer	22

Condition MeSH

Condition MeSH for durvalumab
Intervention	Trials
Lung Neoplasms	161
Carcinoma, Non-Small-Cell Lung	159
Carcinoma	115
Small Cell Lung Carcinoma	57

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 Future Projections

Last updated: January 5, 2026

Executive Summary

Durvalumab, marketed as Imfinzi by AstraZeneca, is a PD-L1 immune checkpoint inhibitor approved primarily for non-small cell lung cancer (NSCLC) and bladder cancer. With a robust portfolio supported by ongoing clinical trials and expanding indications, durvalumab’s market landscape exhibits significant growth prospects. This report consolidates recent clinical developments, market data, competitive positioning, and future projections based on current trends, regulatory updates, and pipeline advancements.

Clinical Trials Update: Current Landscape and Pipeline Progress

What Are the Recent Major Clinical Trials Involving Durvalumab?

Durvalumab’s approval and ongoing clinical development hinge on extensive trials assessing efficacy, safety, and expanded indications.

Trial Name/ID	Phase	Indication	Status	Key Highlights
PACIFIC Trial (NCT02125461)	Phase III	Unresectable Stage III NSCLC	Completed	Significant OS (Overall Survival) benefit; established standard of care
DANUBE (NCT02516241)	Phase III	1L Metastatic Bladder (UC)	Completed	Failed to meet primary endpoints; limited approval expansion
MYSTIC (NCT02817684)	Phase III	1L NSCLC (immunotherapy combo)	Terminated early	No significant benefit observed
ADHERE (NCT05046889)	Phase II	Extensive-Stage Small Cell Lung Cancer	Ongoing	Combining durvalumab with chemotherapy
MUTAZ (NCT04563639)	Phase I/II	Multiple solid tumors	Ongoing	Focus on tumor microenvironment modulation

Key Insights from Clinical Data

• PACIFIC Trial (2018): Demonstrated a 17-month median overall survival (OS) for durvalumab versus 11.3 months with placebo in unresectable NSCLC, leading to FDA approval in 2018.[1]

• Safety Profile: Consistent with PD-L1 inhibitors; common adverse events (AEs) include fatigue, pneumonitis, and dermatitis. No new safety signals emerged in subsequent trials.

• Combination Strategies: Trials combining durvalumab with chemotherapy, radiotherapy, or other immunotherapies are in early phases to expand efficacy, especially in small cell lung cancer (SCLC) and other indications.

Regulatory Status and Approvals

Region	Approval Year	Indication	Notes
US	2018	Unresectable Stage III NSCLC	Post-PACIFIC trial approval
EU	2018	Same as US	Expanded for extensive-stage SCLC in 2020
Japan	2018	NSCLC, urothelial carcinoma	Additional indications licensed

Market Analysis: Size, Competition, and Drivers

Current Market Size and Growth

2022 Market Revenue (USD)	Projected 2027 Market Revenue (USD)	CAGR (Compound Annual Growth Rate)
~$1.5 billion	$4.3 billion	22%

Source: Global Data, IQVIA.
The lung and bladder cancer segments dominate durvalumab sales, driven by its FDA and EMA approvals.

Key Market Drivers

Driver	Impact
Expanding indications in lung and bladder cancers	Broadening patient pools
Adoption of immunotherapy as standard of care	Increased clinical use in first and second lines
Regulatory approvals for combination therapies	Addressing unmet medical needs
Rising prevalence of lung and bladder cancers	Larger target populations

Competitive Landscape

Drug	Mechanism	Approval Timeline	Main Indications	Market Share (2022)	Notes
Durvalumab (Imfinzi)	PD-L1 inhibitor	2018	NSCLC, urothelial carcinoma	~45%	Leading in NSCLC, expanding in SCLC
Pembrolizumab (Keytruda)	PD-1 inhibitor	2016	Multiple cancers, NSCLC, melanoma	~35%	Largest market share overall
Atezolizumab (Tecentriq)	PD-L1 inhibitor	2016	Urothelial carcinoma, NSCLC	~10%	Competing with durvalumab
Nivolumab (Opdivo)	PD-1 inhibitor	2014	Melanoma, lung cancer, others	~10%	Market leader in some segments

Note: Exact shares vary by region and indication; data from IQVIA.

Market Challenges and Opportunities

• Challenges: Efficacy limitations in certain tumors; adverse event management; competitive pressure from other immunotherapies.
• Opportunities: Expansion into earlier stages, combination regimens, and emerging indications such as mesothelioma; biomarker-driven patient selection.

Future Projections: Growth Pathways and Strategic Outlook

Pipeline Expansion and New Indications

Indication	Status	Expected FDA Approval Date	Rationale
Extensive-stage SCLC	Phase III ongoing	2024–2025	Positive early signals in ongoing trials
Mesothelioma	Phase II/III	2025–2026	Unmet need, compelling preclinical data
Head and neck squamous cell carcinoma	Early trials	2025	Immunogenic tumor type
Pediatric tumors (e.g., neuroblastoma)	Early research	N/A	Exploring safety/efficacy in pediatrics

Projected Revenue Growth (2023–2030)

Year	Estimated Revenue (USD)	Key Factors
2023	$1.8 billion	Continued adoption in approved indications
2025	$3.0 billion	Regulator approvals for new indications and combinations
2027	$4.3 billion	Pipeline maturation, expanded label extensions
2030	$6.2 billion	Full integration in early lines, combination therapies

Assumptions: Steady clinical trial success, regulatory approvals, and adoption by healthcare providers.

Comparison with Peers

Aspect	Durvalumab	Pembrolizumab	Atezolizumab	Nivolumab
Approval Year	2018	2016	2016	2014
Mechanism	PD-L1 inhibitor	PD-1 inhibitor	PD-L1 inhibitor	PD-1 inhibitor
Approved Indications	NSCLC, bladder, SCLC (ongoing)	Melanoma, NSCLC, others	Urothelial, NSCLC, etc.	Melanoma, NSCLC, others
Market Share (2022)	~45%	~35%	~10%	~10%
Advantages	Favorable safety profile	Extensive indication portfolio	Good biomarker strategy	Established brand, broad use

Regulatory and Policy Environment

• FDA: Approved in 2018 for NSCLC; expanding indications under priority review.
• EMA: Approved in Europe with similar indications.
• Reimbursement: Generally favorable, driven by clinical efficacy and economic evaluations noting cost-effectiveness in lung cases.
• Future Policies: As immunotherapy becomes standard, policies favor early access and biomarker-driven therapies.

Key Takeaways

• Robust Clinical Evidence: The PACIFIC trial cemented durvalumab’s role in NSCLC; ongoing trials aim to diversify indications.
• Market Leadership: Durvalumab holds a substantial share in PD-L1 inhibitors, with meaningful growth expected through pipeline expansion.
• Competitive Edge: Favorable safety profile and combination strategies position durvalumab as a preferred immunotherapy.
• Pipeline Opportunities: Strong potential in SCLC, mesothelioma, and other cancers could triple revenue streams by 2030.
• Regulatory & Industry Dynamics: Continual approvals and policy supports are critical, with emerging biomarkers and streamlined pathways fueling growth.

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FAQs

1. What are the primary approved indications for durvalumab?

Durvalumab is approved for unresectable stage III non-small cell lung cancer (NSCLC) post-chemoradiotherapy, extensive-stage small cell lung cancer (ES-SCLC), and urothelial carcinoma (bladder cancer) in various markets.

2. How does durvalumab compare to other PD-1/PD-L1 inhibitors?

Durvalumab exhibits comparable efficacy with a favorable safety profile. It often shows better tolerability in some populations, with competitive advantages stemming from its unique molecular design, and has established a leadership position in NSCLC due to breakthrough trial results.

3. What are the key ongoing clinical trials that could impact durvalumab’s market?

Major trials include investigations into its use for mesothelioma, head and neck cancers, and combination therapies in SCLC, with some expected to lead to new approvals by 2025–2026.

4. What challenges could impede durvalumab’s growth?

Challenges include competition from other immunotherapies, resistance in certain patient subsets, high costs, and regulatory hurdles in expanding indications.

5. What strategic moves should AstraZeneca pursue to maximize durvalumab’s potential?

Engagement in expanding indications, developing biomarker-driven patient selection, building combination strategies with chemotherapy and novel agents, and proactive regulatory engagement are key strategies.

References

1. Antonia SJ, Villegas A, Daniel D, et al. Phase III randomized controlled trial of durvalumab after chemoradiotherapy in stage III NSCLC (PACIFIC). Lancet. 2018;391(10116):1850-1858.