CLINICAL TRIALS PROFILE FOR IRESSA

All Clinical Trials for Iressa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005806 ↗	Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.
NCT00005806 ↗	Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.
NCT00006048 ↗	ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer	Unknown status	AstraZeneca	Phase 3	2000-05-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
NCT00006049 ↗	ZD 1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer	Unknown status	AstraZeneca	Phase 3	2000-05-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage III or stage IV non-small cell lung cancer.
NCT00012337 ↗	ZD 1839 in Treating Patients With Metastatic Kidney Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-01-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to die. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have metastatic kidney cancer.
NCT00012337 ↗	ZD 1839 in Treating Patients With Metastatic Kidney Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2001-01-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to die. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have metastatic kidney cancer.
NCT00014170 ↗	Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme	Completed	National Cancer Institute (NCI)	Phase 2	2001-03-01	Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

Clinical Trial Conditions for Iressa

Condition Name

Condition Name for Iressa
Intervention	Trials
Non-small Cell Lung Cancer	28
Lung Cancer	23
Breast Cancer	17
Head and Neck Cancer	14

Condition MeSH

Condition MeSH for Iressa
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	97
Lung Neoplasms	85
Breast Neoplasms	23
Head and Neck Neoplasms	23

Clinical Trial Locations for Iressa

Trials by Country

Trials by Country for Iressa
Location	Trials
United States	364
China	82
Italy	55
Japan	45
Canada	42

Trials by US State

Trials by US State for Iressa
Location	Trials
Texas	22
New York	21
California	20
Pennsylvania	19
Massachusetts	19

Clinical Trial Progress for Iressa

Clinical Trial Phase

Clinical Trial Phase for Iressa
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	36
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Iressa
Clinical Trial Phase	Trials
Completed	152
Terminated	28
Unknown status	28

Clinical Trial Sponsors for Iressa

Sponsor Name

Sponsor Name for Iressa
Sponsor	Trials
AstraZeneca	103
National Cancer Institute (NCI)	51
Massachusetts General Hospital	7

Sponsor Type

Sponsor Type for Iressa
Sponsor	Trials
Other	208
Industry	135
NIH	53

IRESSA: Clinical Trials, Market Analysis, and Projections

Introduction

IRESSA, also known as gefitinib, is a targeted therapy developed by AstraZeneca for the treatment of non-small cell lung cancer (NSCLC), particularly in patients with specific epidermal growth factor receptor (EGFR) mutations. Here, we will delve into the clinical trials, market analysis, and future projections for IRESSA.

Clinical Trials and Approval History

Initial Approval

IRESSA was first approved by the FDA in 2003 for the treatment of advanced NSCLC in patients whose disease had progressed despite treatment with platinum-based and docetaxel chemotherapy. This approval was based on a phase II trial involving 216 patients, which showed a 10.6% overall response rate, with a median response duration of 7 months[3].

Safety Concerns and Postmarketing Studies

The initial approval was conditional, requiring AstraZeneca to conduct postmarketing studies to confirm clinical benefit and evaluate long-term safety. Notably, the FDA delayed the approval to investigate reports of interstitial lung disease (ILD) associated with IRESSA, particularly in Japanese patients. The incidence of ILD was found to be about 2% in Japan and 0.3% in the expanded access program, with a mortality rate of approximately 33%[3].

First-Line Treatment Approval

In 2015, the FDA approved IRESSA for the first-line treatment of patients with metastatic NSCLC who have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. This approval was based on data from the IFUM1 and IPASS2 clinical trials, which demonstrated the efficacy of IRESSA in this patient population[4].

Ongoing and Recent Trials

A phase II study (ICARUS) is currently investigating the efficacy, safety, and tolerability of IRESSA as a third-line treatment in patients with EGFR mutation-positive NSCLC who have responded to gefitinib as first-line treatment and progressed after second-line chemotherapy. This study aims to characterize the benefits of re-challenging patients with IRESSA[1].

Mechanism of Action

IRESSA is an oral EGFR tyrosine kinase inhibitor (TKI) that works by blocking the activity of the EGFR tyrosine kinase enzyme. This inhibition disrupts the signaling pathways involved in the growth and survival of cancer cells, leading to an inhibition of cancer cell proliferation and an increase in apoptosis[4].

Market Analysis

Global Market Trends

The global NSCLC market is projected to grow significantly, with sales expected to reach $26.8 billion by 2025, driven by a Compound Annual Growth Rate (CAGR) of 15.7%. The China NSCLC market is anticipated to be a major driver, growing at a robust CAGR of 25.4%[5].

IRESSA Market Position

IRESSA is approved in 91 countries for the treatment of adult patients with locally advanced or metastatic EGFR mutation-positive NSCLC. The drug's market position is strengthened by its targeted mechanism and the availability of a companion diagnostic test, the therascreen® EGFR test, which helps identify patients who are likely to benefit from IRESSA treatment[4].

Competitive Landscape

The NSCLC market is highly competitive, with other EGFR-TKIs such as Tarceva and newer agents like Tagrisso, Alecensa, and Zykadia. However, IRESSA remains a significant player, particularly in the first-line treatment of EGFR mutation-positive patients. The market share of EGFR-TKIs is expected to grow, albeit at a moderate CAGR of 4.9%, compared to the more rapid growth of immunotherapy (IO) therapies, which are projected to dominate the market by 2025[5].

Projections and Future Outlook

Market Growth

Despite the competitive landscape, IRESSA is expected to maintain its market presence due to its established safety profile and efficacy in specific patient populations. The global uptake of targeted therapies, including EGFR-TKIs, will continue to drive market growth, although at a slower pace compared to IO therapies[5].

Combination Therapies

AstraZeneca is exploring the potential of IRESSA in combination with other investigational medicines, such as the anti-PD-L1 monoclonal antibody durvalumab. These combination therapies could expand the treatment options for a broader range of lung cancer patients and potentially enhance the market position of IRESSA[4].

Patent and Generic Impact

The patent expiration of several blockbuster drugs, including Tarceva, will lead to increased competition from generics. However, IRESSA's unique positioning and the ongoing development of combination therapies are expected to mitigate the impact of generic competition to some extent[5].

Key Takeaways

• Clinical Trials: IRESSA has undergone extensive clinical trials, including phase II and phase IV studies, to establish its efficacy and safety in NSCLC patients with EGFR mutations.
• Market Approval: Approved for first-line treatment in patients with specific EGFR mutations and as a third-line treatment in certain cases.
• Mechanism of Action: Works by inhibiting the EGFR tyrosine kinase enzyme, disrupting cancer cell growth and survival pathways.
• Market Trends: The NSCLC market is growing, driven by targeted therapies and IO therapies, with IRESSA maintaining a significant market presence.
• Future Outlook: Combination therapies and the development of new diagnostic tests are expected to enhance IRESSA's market position despite increasing competition.

FAQs

What is IRESSA used for?

IRESSA (gefitinib) is used for the treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.

What are the common side effects of IRESSA?

Common side effects include diarrhea, skin reactions such as rash, acne, dry skin, and pruritus[4].

How is IRESSA administered?

IRESSA is administered as a 250-mg tablet taken once daily[4].

What is the significance of the therascreen® EGFR test?

The therascreen® EGFR test is a companion diagnostic that helps identify patients with EGFR mutations who are likely to benefit from IRESSA treatment[4].

What are the future prospects for IRESSA in the NSCLC market?

IRESSA is expected to maintain its market presence through its established safety profile, efficacy, and potential use in combination therapies, despite the growing competition from IO therapies and generics[5].

Sources

1. AstraZeneca Clinical Trials: Iressa re-Challenge in Advanced NSCLC EGFR M+ Patients who Responded to gefitinib Used as 1st line or previous treatment - ICARUS.
2. Cognitive Market Research: Global Iressa Market Report 2024 Edition.
3. Cancer Network: FDA Approves Iressa for Advanced NSCLC Patients.
4. AstraZeneca Media Centre: IRESSA approved by US FDA for first-line treatment of patients with metastatic NSCLC.
5. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.

Last updated: 2025-01-05