CLINICAL TRIALS PROFILE FOR AFATINIB DIMALEATE

All Clinical Trials for Afatinib Dimaleate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02122172 ↗	Afatinib in Advanced Refractory Urothelial Cancer	Recruiting	National Cancer Institute (NCI)	Phase 2	2013-10-30	This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.
NCT02122172 ↗	Afatinib in Advanced Refractory Urothelial Cancer	Recruiting	University of Chicago	Phase 2	2013-10-30	This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.
NCT02131259 ↗	Long-term Observation PMS for Afatinib	Completed	Boehringer Ingelheim		2014-05-07	In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
NCT02285361 ↗	GIOTRIF rPMS in Korean Patients With NSCLC	Completed	Boehringer Ingelheim		2014-10-31	To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
NCT02364609 ↗	Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib	Completed	National Cancer Institute (NCI)	Phase 1	2015-09-30	This phase I/Ib trial studies the side effects and best dose of pembrolizumab when given together with afatinib dimaleate in treating patients with non-small cell lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment, or has come back and does not respond to erlotinib hydrochloride. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and afatinib dimaleate together may be an effective treatment for non-small cell lung cancer.
NCT02364609 ↗	Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib	Completed	University of California, Davis	Phase 1	2015-09-30	This phase I/Ib trial studies the side effects and best dose of pembrolizumab when given together with afatinib dimaleate in treating patients with non-small cell lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment, or has come back and does not respond to erlotinib hydrochloride. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and afatinib dimaleate together may be an effective treatment for non-small cell lung cancer.

Clinical Trial Conditions for Afatinib Dimaleate

Condition Name

Condition Name for Afatinib Dimaleate
Intervention	Trials
Advanced Malignant Solid Neoplasm	3
Recurrent Pancreatic Carcinoma	2
Refractory Plasma Cell Myeloma	2
Carcinoma, Non-Small-Cell Lung	2

Condition MeSH

Condition MeSH for Afatinib Dimaleate
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	5
Lung Neoplasms	4
Neoplasms	3
Neoplasms, Plasma Cell	2

Clinical Trial Locations for Afatinib Dimaleate

Trials by Country

Trials by Country for Afatinib Dimaleate
Location	Trials
United States	101
Japan	2
Puerto Rico	1
Guam	1
Korea, Republic of	1

Trials by US State

Trials by US State for Afatinib Dimaleate
Location	Trials
Indiana	3
Washington	3
California	3
North Carolina	3
New York	3

Clinical Trial Progress for Afatinib Dimaleate

Clinical Trial Phase

Clinical Trial Phase for Afatinib Dimaleate
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Afatinib Dimaleate
Clinical Trial Phase	Trials
Recruiting	3
Completed	3
Active, not recruiting	2

Clinical Trial Sponsors for Afatinib Dimaleate

Sponsor Name

Sponsor Name for Afatinib Dimaleate
Sponsor	Trials
National Cancer Institute (NCI)	6
Boehringer Ingelheim	2
Shanghai Chest Hospital	1

Sponsor Type

Sponsor Type for Afatinib Dimaleate
Sponsor	Trials
NIH	6
Other	5
Industry	2

Afatinib Dimaleate: Clinical Trials, Market Analysis, and Projections

Introduction

Afatinib dimaleate, a tyrosine kinase inhibitor, has been a significant player in the treatment of non-small cell lung cancer (NSCLC), particularly in patients with epidermal growth factor receptor (EGFR) mutations. Here, we delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

S1403 Trial: Afatinib Dimaleate With or Without Cetuximab

A randomized phase II/III trial, S1403, is currently underway to evaluate the efficacy of afatinib dimaleate with or without cetuximab in treating patients with newly diagnosed stage IV or recurrent EGFR mutation positive NSCLC. The primary objectives include comparing progression-free survival (PFS) and overall survival (OS) between the two treatment arms. Secondary objectives focus on overall response rates, safety assessments, and the impact of molecular mechanisms on clinical outcomes[1].

Patient-Reported Symptom Burden and HRQoL

Another study aims to assess the impact of afatinib therapy on patient-reported lung cancer-specific symptom burden and health-related quality of life (HRQoL) in real-world clinical settings. This non-interventional study in Greece evaluates symptoms, total symptomatic distress, functional activity, and HRQoL over 6 months of therapy. The results have shown significant improvements in symptoms and HRQoL compared to chemotherapy, highlighting afatinib's benefits in managing disease-related symptoms[3].

Afatinib in Chordoma Patients

Recent results from a Phase 2 clinical trial supported by the Chordoma Foundation indicate that a subset of chordoma patients benefit from afatinib. The trial showed that 40% of patients avoided tumor progression at 12 months, and 13% achieved a partial response. The median PFS for patients with a partial response was nearly 28 months, underscoring the potential of afatinib in this patient population[4].

Market Analysis

Market Size and Growth

The Afatinib Dimaleate Market has experienced significant growth in recent years and is projected to continue this trend. The market size is expected to reach substantial values by 2031, driven by the increasing demand for the treatment of EGFR-mutated NSCLC and NSCLC patients with squamous cell carcinoma histologically. The market is segmented by type (20 mg, 30 mg, 40 mg), application, and geographical regions[2][5].

Key Drivers and Restraints

The growth of the Afatinib Dimaleate Market is driven by several factors, including the rising incidence of NSCLC, advancements in targeted therapies, and the efficacy of afatinib in improving PFS and OS. However, the market also faces restraints such as high treatment costs, potential side effects, and the need for biomarkers to predict patient response to EGFR inhibitors[5].

Geographical Segmentation

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to show significant growth due to the large patient population and increasing healthcare expenditure in countries like China and India[2][5].

Market Projections

Forecast Period

The Afatinib Dimaleate Market is forecasted to grow at a remarkable CAGR from 2023 to 2031. This growth is attributed to the increasing adoption of targeted therapies, improved patient outcomes, and expanding healthcare infrastructure in emerging markets[5].

Lucrative Opportunities

The market report highlights lucrative opportunities at the country level, emphasizing the need for detailed analysis of product pricing, penetration rates, and consumer behavior. The report also considers economic, political, and social factors influencing market dynamics[5].

Competitive Landscape

The market is characterized by the presence of key players, including Boehringer Ingelheim, the primary developer of afatinib dimaleate. The competitive landscape is expected to evolve with the entry of new players and the development of biosimilars, which could impact market dynamics[2].

Patient Outcomes and Quality of Life

Symptom Improvement

Studies have consistently shown that afatinib improves patient-reported symptoms such as cough, dyspnea, and pain, and enhances HRQoL compared to traditional chemotherapy. These improvements are crucial for maintaining the quality of life in patients with advanced NSCLC[3].

Adherence and Safety

Afatinib has been shown to have manageable side effects through dose reductions and supportive care. The treatment discontinuation rate due to adverse events is significantly lower compared to chemotherapy, indicating better tolerability and adherence to afatinib therapy[3].

Key Takeaways

• Clinical Efficacy: Afatinib dimaleate has demonstrated significant efficacy in treating EGFR-mutated NSCLC, improving PFS and OS.
• Market Growth: The Afatinib Dimaleate Market is projected to grow substantially from 2023 to 2031, driven by increasing demand and improving patient outcomes.
• Geographical Expansion: The Asia-Pacific region is expected to be a key growth area due to its large patient population and increasing healthcare expenditure.
• Patient Outcomes: Afatinib improves patient-reported symptoms and HRQoL, making it a preferred treatment option for many patients.

FAQs

What is the primary use of afatinib dimaleate in clinical practice?

Afatinib dimaleate is primarily used in the treatment of patients with newly diagnosed stage IV or recurrent EGFR mutation positive non-small cell lung cancer.

How does afatinib dimaleate compare to chemotherapy in terms of patient outcomes?

Afatinib dimaleate has been shown to improve progression-free survival, overall survival, and health-related quality of life compared to chemotherapy, with fewer side effects and better tolerability.

What are the key drivers of the Afatinib Dimaleate Market growth?

The growth is driven by the rising incidence of NSCLC, advancements in targeted therapies, and the efficacy of afatinib in improving patient outcomes.

Which geographical region is expected to show significant growth in the Afatinib Dimaleate Market?

The Asia-Pacific region is expected to show significant growth due to its large patient population and increasing healthcare expenditure.

Are there any ongoing studies to identify biomarkers for predicting patient response to afatinib?

Yes, there are ongoing studies to identify biomarkers that can predict which patients are most likely to benefit from EGFR inhibitors like afatinib, particularly in chordoma patients[4].

Sources

1. UCSD Lung Cancer Trial: S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer.
2. Market Research Intellect: Afatinib Dimaleate Market Size, Scope And Forecast Report.
3. ClinicalTrials.gov: Non-interventional Study Protocol - Assessing the Impact of Afatinib Therapy on Patient-Reported Lung Cancer-Specific Symptom Burden.
4. Chordoma Foundation: Phase 2 Afatinib Results and Other ASCO Advances.
5. Verified Market Reports: Afatinib Dimaleate Market Size, Share, Trends | Industry Forecast.