CLINICAL TRIALS PROFILE FOR IMFINZI

All Clinical Trials for IMFINZI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for IMFINZI

Condition Name

Condition Name for IMFINZI
Intervention	Trials
Stage III Lung Cancer AJCC v8	8
Stage IIIB Lung Cancer AJCC v8	8
Stage IIIA Lung Cancer AJCC v8	8
Stage IIIC Lung Cancer AJCC v8	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

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

Trials by US State

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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
Phase 3	10
Phase 2/Phase 3	2
Phase 2	69

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	135
Industry	79
NIH	34

Clinical Trials and Efficacy of IMFINZI

IMFINZI, also known as durvalumab, is a PD-L1 inhibitor that has been extensively studied in various clinical trials for its efficacy in treating different types of cancers.

Clinical Trials in Advanced Bladder and Urinary Tract Cancer

IMFINZI was approved by the FDA based on evidence from a clinical trial involving 182 patients with advanced bladder and urinary tract cancer. In this trial, 17% of the patients treated with IMFINZI showed complete or partial shrinkage of their cancer. Notably, 45% of the responding patients maintained their response for more than 6 months, and some for 12 months or longer[1].

Clinical Trials in Non-Small Cell Lung Cancer (NSCLC)

In the context of NSCLC, IMFINZI has demonstrated significant benefits. A clinical trial compared patients with unresectable Stage 3 NSCLC who received IMFINZI after completing chemoradiation therapy (CRT) to those who received a placebo. The results showed that the median time tumors did not grow or spread was 16.8 months for patients receiving IMFINZI, compared to 5.6 months for those receiving the placebo. This trial measured overall survival and progression-free survival, with IMFINZI significantly extending both parameters[4].

Clinical Trials in Small Cell Lung Cancer (SCLC)

Recently, IMFINZI has shown promising results in limited-stage small cell lung cancer (LS-SCLC). The phase 3 ADRIATIC trial demonstrated that IMFINZI significantly extended patients’ lives and prolonged the time before tumor progression or death compared to placebo. This makes IMFINZI the first immunotherapy to show a survival benefit in this setting[5].

Ongoing and Future Trials

Several ongoing clinical trials are investigating the efficacy of IMFINZI in other cancer types, including malignant pleural mesothelioma (MPM). For example, the PrE0505 and DREAM3R trials are evaluating IMFINZI in combination with standard chemotherapy for MPM patients. These trials aim to assess the first-line treatment efficacy of IMFINZI in advanced pleural mesothelioma[3].

Market Analysis and Projections for IMFINZI

Market Size and Growth

The immune checkpoint inhibitors market, which includes IMFINZI, is projected to grow significantly. By 2025, this market is expected to reach $56.53 billion, up from $10.56 billion in 2017, with a Compound Annual Growth Rate (CAGR) of 20.1% from 2018 to 2025. The PD-L1 inhibitor segment, where IMFINZI belongs, is expected to grow at a CAGR of 34.2% during this period due to increased adoption and R&D activities[2].

Market Share and Dominance

The PD-1 inhibitor segment currently dominates the market, capturing 82% of the total market share in 2017. However, the PD-L1 inhibitor segment, which includes drugs like IMFINZI and Bavencio, is expected to grow rapidly. IMFINZI, although having a marginal share currently, is anticipated to gain more market share as it expands into new indications and demonstrates positive clinical outcomes[2].

Geographic Market

North America is the largest revenue contributor to the immune checkpoint inhibitors market and is expected to maintain its dominance. However, the Asia-Pacific region is projected to be the fastest-growing market, with a CAGR of 22.1% through 2025, driven by factors such as increasing awareness, rising healthcare expenditure, and a growing prevalence of cancer[2].

Competitive Landscape

The market for immune checkpoint inhibitors is highly competitive, with key players including AstraZeneca (the manufacturer of IMFINZI), Bristol Myers Squibb, and Merck & Co. IMFINZI faces competition from other successful drugs like Opdivo and Keytruda but is expected to carve out its own niche with its unique clinical benefits and expanding indications[2].

Future Market Assessments

Forecasted Sales

The forecasted sales data for IMFINZI from 2026 to 2032 indicate a positive trend, especially as the drug gains approvals in new indications. For malignant pleural mesothelioma, the market scenario is expected to change significantly due to extensive research and incremental healthcare spending, which will expand the market size and allow drug manufacturers to penetrate deeper[3].

Emerging Therapies and Challenges

The launch of late-stage emerging therapies in the near future will significantly impact the market for IMFINZI. Other products for malignant pleural mesothelioma are expected to provide tough competition, but IMFINZI's strong clinical data and expanding indications position it well in the market[3].

Key Takeaways

• Clinical Efficacy: IMFINZI has shown significant efficacy in various clinical trials for advanced bladder and urinary tract cancer, NSCLC, and SCLC.
• Market Growth: The immune checkpoint inhibitors market, including IMFINZI, is projected to grow substantially, reaching $56.53 billion by 2025.
• Geographic Expansion: North America dominates the market, but the Asia-Pacific region is expected to be the fastest-growing.
• Competitive Landscape: IMFINZI faces competition but is expected to gain market share with its unique clinical benefits.
• Future Projections: Forecasted sales indicate a positive trend, especially with new indications and expanding market size.

FAQs

Q: What is IMFINZI used for?

IMFINZI (durvalumab) is used to treat various types of cancers, including advanced bladder and urinary tract cancer, non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC).

Q: What were the key findings of the clinical trials for IMFINZI in NSCLC?

In clinical trials for NSCLC, IMFINZI significantly extended the time tumors did not grow or spread and improved overall survival compared to placebo[4].

Q: How does IMFINZI compare to other immune checkpoint inhibitors in the market?

IMFINZI, while having a marginal market share currently, is expected to grow rapidly due to its positive clinical outcomes and expanding indications. It competes with drugs like Opdivo and Keytruda but has unique benefits[2].

Q: What are the future market projections for IMFINZI?

The market for IMFINZI is expected to grow as the drug gains approvals in new indications and expands its market size, especially in the Asia-Pacific region[2][3].

Q: What are the ongoing clinical trials for IMFINZI?

Several ongoing trials are investigating IMFINZI's efficacy in malignant pleural mesothelioma, including the PrE0505 and DREAM3R trials[3].

Sources

1. FDA: Drug Trials Snapshots: IMFINZI - FDA.
2. Biospace: Immune Checkpoint Inhibitors Market Size to Reach $56.53 Billion ...
3. Research and Markets: IMFINZI Emerging Drug Insight and Market Forecast - 2032.
4. Imfinzi.com: NSCLC Clinical Trial Results for IMFINZI® (durvalumab).
5. FiercePharma: AstraZeneca's Imfinzi tackles another type of lung cancer with latest trial win.