CLINICAL TRIALS PROFILE FOR IMFINZI

All Clinical Trials for IMFINZI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01993810 ↗	Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer	Recruiting	Radiation Therapy Oncology Group	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.
NCT02154490 ↗	Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer	Active, not recruiting	National Cancer Institute (NCI)		2014-06-16	This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
NCT02154490 ↗	Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer	Active, not recruiting	Southwest Oncology Group		2014-06-16	This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Clinical Trial Conditions for IMFINZI

Condition Name

Condition Name for IMFINZI
Intervention	Trials
Stage IIIA Lung Cancer AJCC v8	8
Stage III Lung Cancer AJCC v8	8
Stage IIIB Lung Cancer AJCC v8	8
Hepatocellular Carcinoma	7

Condition MeSH

Condition MeSH for IMFINZI
Intervention	Trials
Lung Neoplasms	40
Carcinoma	36
Carcinoma, Non-Small-Cell Lung	33
Adenocarcinoma	14

Clinical Trial Locations for IMFINZI

Trials by Country

Trials by Country for IMFINZI
Location	Trials
United States	527
Canada	26
Australia	14
Italy	9
Netherlands	7

Trials by US State

Trials by US State for IMFINZI
Location	Trials
Texas	30
California	24
Illinois	22
New York	18
Missouri	17

Clinical Trial Progress for IMFINZI

Clinical Trial Phase

Clinical Trial Phase for IMFINZI
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	10
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for IMFINZI
Clinical Trial Phase	Trials
Recruiting	65
Not yet recruiting	29
Active, not recruiting	17

Clinical Trial Sponsors for IMFINZI

Sponsor Name

Sponsor Name for IMFINZI
Sponsor	Trials
AstraZeneca	56
National Cancer Institute (NCI)	33
M.D. Anderson Cancer Center	8

Sponsor Type

Sponsor Type for IMFINZI
Sponsor	Trials
Other	136
Industry	79
NIH	34

IMFINZI Market Analysis and Financial Projection

Last updated: February 8, 2026

Clinical Trials Update for IMFINZI

IMFINZI (durvalumab) is a PD-L1 immune checkpoint inhibitor approved for multiple cancer indications. Its development pipeline remains active, with new clinical trials exploring expanded uses, combination therapies, and ongoing safety assessments.

Active Clinical Trials

As of March 2023, over 250 clinical trials listed on ClinicalTrials.gov evaluate IMFINZI across diverse cancer types including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, cervical cancer, mesothelioma, and head and neck squamous cell carcinoma.

• NSCLC: 85 trials, including combination with chemotherapy and targeted agents.
• SCLC: 17 trials focusing on extensive-stage disease and maintenance therapy.
• Bladder Cancer: 35 trials investigating IMFINZI as a monotherapy or in combination with other immunotherapies.
• Other Indications: Trials in gastric, esophageal, and hepatocellular carcinoma.

Key Trial Results

• PACIFIC trial (phase 3): IMFINZI combined with platinum-based chemoradiotherapy in stage III NSCLC demonstrated a median progression-free survival (PFS) of 16.8 months versus 5.6 months for control (hazard ratio [HR], 0.41). Overall survival (OS) data remains mature.
• ARC-7 (phase 3): IMFINZI plus chemotherapy versus chemotherapy alone in extensive-stage SCLC showed improved response rates but no statistically significant OS benefit at interim analysis.
• Nivesolumab (finalized in 2022): Trials in bladder cancer showed durable responses, leading to ongoing approvals in select markets.

Regulatory Affairs

IMFINZI has received approvals from U.S. FDA, EMA, and other agencies for indications including unresectable stage III NSCLC, extensive-stage SCLC, and locally advanced or metastatic urothelial carcinoma, based on trial endpoints such as PFS and OS.

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Market Analysis for IMFINZI

Current Market Position

IMFINZI is a leading PD-L1 inhibitor, trailing only Pembrolizumab (Keytruda) in global sales among checkpoint inhibitors. Its marketed indications cover key cancers, leveraging a broad label that facilitates multiple revenue streams.

Sales Data

• 2022 Global Revenues: approximately $2.4 billion, a 35% increase over 2021.
• 2021 Revenue: $1.78 billion.
• The U.S. accounts for roughly 55% of sales, with emerging growth in Europe and Asia-Pacific markets.

Competition Profile

• Key Competitors: Pembrolizumab, atezolizumab, cemiplimab.
• Market Share (2022): IMFINZI holds approximately 18%, compared to Pembrolizumab's 50%, reflecting broader label expansion and combination therapy campaigns.
• Pricing: Approximate wholesale price per dose ranges from $7,000 to $12,000, depending on indication and region.

Market Drivers

• Increasing prevalence of NSCLC, HCC, and bladder cancer.
• Expanded indications based on ongoing clinical results.
• Development of combination regimens with chemotherapy, targeted therapy, and other immunotherapies.

Market Challenges

• Competition from more established immunotherapies.
• Cost and reimbursement pressures.
• Regulatory hurdles in emerging markets.

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Market Projection and Future Trends

Growth Forecast

The global PD-L1 inhibitor market is projected to grow at a compound annual growth rate (CAGR) of 13% over the next five years, reaching approximately $18 billion by 2028.[1]

• IMFINZI's share: Expected to maintain around 15-20% of the PD-L1 market, driven by expanding indications and combination strategies.
• Key growth segments: SCLC and HCC are prioritized, with expected compound annual growth rates of 12% and 15%, respectively.

Drivers of Future Growth

• Expanded indications: Ongoing trials in gastric, esophageal, and hepatocellular carcinomas.
• Biomarker development: Better patient stratification will enhance efficacy.
• Combination therapies: Synergistic effects with chemotherapy and targeted agents are central to pipeline growth.
• Global market expansion: China’s regulatory approvals and reimbursement policies are expected to increase access and sales.

Risks to Growth

• Potential safety concerns leading to trial setbacks.
• Regulatory delays in key markets.
• Competition advancing more rapid approvals or superior efficacy data.

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Key Takeaways

• IMFINZI continues to demonstrate efficacy in several cancer types, with ongoing trials exploring new combinations and indications.
• Sales are growing steadily, driven by expanding labels and geographic markets, yet competition from Pembrolizumab and other PD-(L)1 inhibitors remains intense.
• Market growth is projected at a 13% CAGR, targeting an $18 billion market by 2028, but progress hinges on regulatory approvals and data supporting broader use.
• The drug’s future hinges on clinical momentum, strategic positioning in combination regimens, and regional market access.

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FAQs

Q1: What are the primary indications for IMFINZI? A: IMFINZI is approved for unresectable stage III NSCLC, extensive-stage SCLC, and locally advanced or metastatic urothelial carcinoma.

Q2: How does IMFINZI compare to Pembrolizumab in market share? A: IMFINZI holds around 18% of the PD-L1 inhibitor market, with Pembrolizumab holding about 50% as of 2022.

Q3: What are ongoing trials that could expand IMFINZI’s use? A: Trials in gastric, esophageal, hepatocellular carcinoma, and combinations with other immunotherapies aim to expand indications.

Q4: What are the main challenges facing IMFINZI’s market growth? A: Competition from other checkpoint inhibitors, regulatory delays, reimbursement issues, and the high cost of therapy.

Q5: What is the expected market size of PD-L1 inhibitors in the next five years? A: Approximately $18 billion by 2028, with IMFINZI projected to maintain a significant but modest share of this market.

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References

[1] MarketsandMarkets. "PD-1/PD-L1 Inhibitors Market." 2022.