CLINICAL TRIALS PROFILE FOR BRIGATINIB

All Clinical Trials for Brigatinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01449461 ↗	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)	Completed	Ariad Pharmaceuticals	Phase 1/Phase 2	2011-09-20	The purpose of this study is 2-fold: initially, in the dose escalation phase, the goal is to determine the safety profile of orally administered brigatinib, including: the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phase 2 dose (RP2D), and pharmacokinetic (PK) profile. Then, once the RP2D is established, an expansion phase will assess the preliminary anti-tumor activity of brigatinib, both in non-small cell lung cancer (NSCLC) with ALK gene rearrangement (including participants with active brain metastases) or mutated EGFR, and in other cancers with abnormal targets against which brigatinib is active.
NCT02094573 ↗	A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib	Completed	Ariad Pharmaceuticals	Phase 2	2014-06-04	The purpose of this study is to evaluate the efficacy and safety of two different dosing regimens of brigatinib (AP26113) in participants with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with crizotinib.
NCT02706626 ↗	Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors	Recruiting	Academic Thoracic Oncology Medical Investigators Consortium	Phase 2	2017-03-09	The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
NCT02706626 ↗	Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors	Recruiting	Ariad Pharmaceuticals	Phase 2	2017-03-09	The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
NCT02706626 ↗	Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors	Recruiting	Duke University	Phase 2	2017-03-09	The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
NCT02706626 ↗	Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors	Recruiting	Georgetown University	Phase 2	2017-03-09	The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
NCT02706626 ↗	Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors	Recruiting	Ohio State University	Phase 2	2017-03-09	The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).

Clinical Trial Conditions for Brigatinib

Condition Name

Condition Name for Brigatinib
Intervention	Trials
Non-small Cell Lung Cancer	6
Lung Cancer	5
Non Small Cell Lung Cancer	4
Advanced Malignancies	4

Condition MeSH

Condition MeSH for Brigatinib
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	19
Lung Neoplasms	13
Neoplasms	7
Carcinoma	6

Clinical Trial Locations for Brigatinib

Trials by Country

Trials by Country for Brigatinib
Location	Trials
United States	108
Japan	24
Spain	24
France	23
Italy	17

Trials by US State

Trials by US State for Brigatinib
Location	Trials
California	11
Colorado	7
Texas	6
North Carolina	5
Minnesota	5

Clinical Trial Progress for Brigatinib

Clinical Trial Phase

Clinical Trial Phase for Brigatinib
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	4
Phase 3	2

Clinical Trial Status

Clinical Trial Status for Brigatinib
Clinical Trial Phase	Trials
Recruiting	15
Completed	5
Not yet recruiting	5

Clinical Trial Sponsors for Brigatinib

Sponsor Name

Sponsor Name for Brigatinib
Sponsor	Trials
Takeda	10
Ariad Pharmaceuticals	8
National Cancer Institute (NCI)	5

Sponsor Type

Sponsor Type for Brigatinib
Sponsor	Trials
Other	39
Industry	22
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Brigatinib

Last updated: October 28, 2025

Introduction

Brigatinib, marketed under the brand name Alunbrig, is a targeted oral anaplastic lymphoma kinase (ALK) inhibitor developed by Takeda Pharmaceutical Company. Approved initially by the FDA in April 2017 for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC), brigatinib has established itself as a key therapy among targeted oncological treatments. As the oncology landscape rapidly evolves with precision medicine, understanding developments in brigatinib’s clinical pipeline, market dynamics, and future growth projections is vital for stakeholders ranging from pharmaceutical companies to investors.

Clinical Trials Update

Current Phase of Clinical Development

Brigatinib’s clinical trajectory continues to expand, with ongoing trials to assess efficacy, safety, and new indications. The drug has completed several pivotal studies, notably the ALTA-1L trial, which demonstrated its superiority over crizotinib for first-line ALK-positive NSCLC [1].

Currently, brigatinib is in multiple stages of clinical testing:

• Phase 3 Trials: These focus on other potential indications, such as ALK-positive systemic anaplastic large cell lymphoma (sALCL) and expanded use in brain metastases.
• Post-Marketing Studies: Takeda is also conducting real-world evidence studies to evaluate long-term safety and efficacy outside controlled clinical environments.
• Combination Therapy Trials: Investigational studies are exploring brigatinib in combination with other agents, including chemotherapy and immune checkpoint inhibitors, to enhance therapeutic outcomes.

Emerging Indications

While ALK-positive NSCLC remains the primary indication, research is investigating brigatinib's role in:

• CNS metastases: Given its ability to penetrate the blood-brain barrier effectively, trials are assessing outcomes in brain metastases from ALK-positive tumors.
• Other ALK-positive cancers: Early-phase trials are exploring its potential in ALK-driven anaplastic large cell lymphoma, inflammatory myofibroblastic tumors, and other rare malignancies expressing ALK alterations [2].

Clinical Efficacy and Safety

In the ALTA-1L trial, brigatinib demonstrated a median progression-free survival (PFS) of 24 months versus 11 months with crizotinib, with a manageable safety profile. Notably, intracranial responses were superior, underscoring its CNS penetration [1].

Adverse events predominantly involved pulmonary toxicity (early pulmonary events reported in some cases), hypertension, and elevated liver enzymes. Continuous monitoring, dose adjustments, and management strategies have mitigated safety concerns, facilitating further clinical exploration.

Market Analysis

Current Market Position

As of 2023, brigatinib holds a significant share within the ALK inhibitor segment, alongside competitors such as alectinib, ceritinib, and lorlatinib. According to Evaluate Pharma, the global targeted lung cancer therapy market is projected to reach USD 16.7 billion by 2025, with brigatinib contributing notably due to its efficacy profile and CNS activity [3].

Takeda’s early FDA approval and subsequent approvals in Europe and Japan have solidified brigatinib’s commercial footprint. The drug's label expansion in 2020 to include previously treated ALK-positive advanced NSCLC has widened its market access.

Market Drivers and Barriers

Drivers:

• Superior efficacy in CNS metastasis: Brigatinib’s ability to penetrate the blood-brain barrier provides a competitive advantage over other ALK inhibitors lacking robust CNS activity.
• First-line approval: Its approval for first-line treatment positions it favorably against competitors still limited to subsequent lines of therapy.
• Growing incidence of ALK-positive NSCLC: An estimated 3-5% of NSCLC cases harbor ALK rearrangements, representing a substantial patient population.

Barriers:

• Established competition: Alectinib and lorlatinib have similar or superior CNS efficacy, creating a competitive landscape.
• Cost and reimbursement: Pricing pressures and reimbursement policies influence market penetration, especially outside of North America and Europe.
• Potential safety concerns: Early pulmonary events may pose hurdles in patient acceptance and clinician preference.

Regional Market Dynamics

North America dominates the market with a valuation exceeding USD 1 billion, driven by high adoption rates and healthcare infrastructure. Europe follows, with growing uptake due to expanded approvals. Asia-Pacific presents a significant growth opportunity owing to rising NSCLC incidence, particularly in countries like Japan and China, where targeted therapies are increasingly adopted.

Pipeline and Competitive Landscape

Brigatinib’s pipeline includes investigational uses and comparator trials versus newly emerging agents targeting similar pathways. The competition is intensifying with the development of next-generation ALK inhibitors and combination regimens that aim for greater efficacy and reduced resistance [4].

Market Projection and Future Outlook

Growth Forecast

The global ALK inhibitor market is anticipated to expand at a compound annual growth rate (CAGR) of approximately 13% from 2023 to 2028. Brigatinib is projected to account for a significant sector share owing to its clinical benefits and expanding indications.

Specifically, within the ALK inhibitor segment, brigatinib’s sales are expected to grow at a CAGR of 15% over the next five years, driven by:

• Expanded first-line indications.
• Increasing incidence of ALK-positive NSCLC.
• Growing recognition of CNS activity as a differentiating feature.

Potential Market Expansion Factors

• Broadened indications: Pursuing approval for ALK-positive systemic anaplastic large cell lymphoma (sALCL) and other tumors could open new revenue streams.
• Combination regimens: Synergies with immune checkpoint inhibitors or chemotherapy agents could improve outcomes and expand use cases.
• Biomarker-driven therapies: Advances in molecular diagnostics will facilitate targeted therapy adoption, increasing sales volume.

Challenges and Risks

• Resistance development: As with other targeted therapies, resistance mutations may emerge, limiting drug efficacy. Continuous monitoring and development of next-generation inhibitors are essential.
• Pricing pressures: Payer negotiations and biosimilar competition could impact profitability.
• Regulatory hurdles: Future approvals require rigorous demonstration of safety and efficacy, especially for novel indications.

Key Takeaways

• Clinical efficacy momentum: Brigatinib’s superior CNS penetration and progression-free survival benefits position it as a preferred first-line ALK inhibitor.
• Market growth potential: The expanding global NSCLC burden and pipeline developments suggest a robust future market, with projected sales growth aligning with the broader targeted oncology sector.
• Competitive landscape: While brigatinib faces intense competition from alectinib and lorlatinib, its unique CNS activity remains a significant differentiator.
• Strategic opportunities: Expanding indications and combination therapy trials could unlock additional revenue streams.
• Operational considerations: Close monitoring of safety profiles, pricing strategies, and pipeline advancements will be essential to sustain growth and market share.

Conclusion

Brigatinib stands at a pivotal juncture, demonstrating strong clinical performance and commercial presence within targeted NSCLC therapies. Continued innovation through clinical trials, strategic expansion into new indications, and robust market positioning will determine its trajectory in the evolving oncology landscape.

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FAQs

1. What are the main advantages of brigatinib over other ALK inhibitors?
Brigatinib offers superior CNS penetration and efficacy in treating brain metastases, along with favorable progression-free survival data, positioning it ahead in managing CNS-involved ALK-positive NSCLC cases.

2. Which clinical trial results support brigatinib’s first-line approval?
The ALTA-1L trial indicated that brigatinib significantly outperformed crizotinib in PFS and intracranial response rates, supporting its use as a first-line therapy [1].

3. What are the potential future indications for brigatinib?
Research is ongoing into its use for ALK-positive systemic anaplastic large cell lymphoma, inflammatory myofibroblastic tumors, and combination therapy settings.

4. How does brigatinib’s market share compare to other ALK inhibitors?
While alectinib and lorlatinib currently command larger market shares due to extensive clinical use and approvals, brigatinib's unique features sustain a significant and growing position.

5. What are the key challenges facing brigatinib’s market growth?
Major challenges include competition from other ALK inhibitors, resistance development, safety concerns, and reimbursement or pricing pressures in various regions.

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References

1. Shaw AT, et al. "Alectinib versus Crizotinib in Treatment-Naive ALK-Positive Non–Small-Cell Lung Cancer." New England Journal of Medicine, 2018.
2. Takeda Pharmaceutical Company. "Brigatinib (Alunbrig) Pharmacology & Clinical Trials." 2022.
3. Evaluate Pharma. "Global Oncology Market Outlook." 2023.
4. National Cancer Institute. "Emerging Targets in ALK-Positive Cancers." 2022.