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CLINICAL TRIALS PROFILE FOR ALUNBRIG

All Clinical Trials for ALUNBRIG

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03420742 ↗	A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors	Completed	Ariad Pharmaceuticals	Phase 1	2019-06-26	The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.
NCT03596866 ↗	A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer	Recruiting	Ariad Pharmaceuticals	Phase 3	2019-04-19	Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: - Brigatinib tablets - Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.
NCT03596866 ↗	A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer	Recruiting	Takeda	Phase 3	2019-04-19	Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: - Brigatinib tablets - Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.
NCT03707938 ↗	Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer	Recruiting	National Cancer Institute (NCI)	Early Phase 1	2018-12-18	This early phase I trial studies the side effects and how well local consolidative therapy (LCT) and brigatinib works in treating patients with non-small cell lung cancer that is stage IV or has come back (recurrent). Giving LCT, such as surgery and/or radiation, after initial treatment may kill any remaining tumor cells. Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LCT and brigatinib may work better in treating patients with non-small cell lung cancer.
NCT03707938 ↗	Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer	Recruiting	M.D. Anderson Cancer Center	Early Phase 1	2018-12-18	This early phase I trial studies the side effects and how well local consolidative therapy (LCT) and brigatinib works in treating patients with non-small cell lung cancer that is stage IV or has come back (recurrent). Giving LCT, such as surgery and/or radiation, after initial treatment may kill any remaining tumor cells. Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LCT and brigatinib may work better in treating patients with non-small cell lung cancer.
NCT03737994 ↗	Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer	Active, not recruiting	NRG Oncology	Phase 2	2019-04-01	This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. Lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, 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 a combination of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with ALK positive non-squamous non-small cell lung cancer.

Clinical Trial Conditions for ALUNBRIG

Condition Name

Condition Name for ALUNBRIG
Intervention	Trials
ALK Gene Rearrangement	3
Stage IV Lung Cancer AJCC v8	3
Stage IVA Lung Cancer AJCC v8	3
Stage IVB Lung Cancer AJCC v8	3

Condition MeSH

Condition MeSH for ALUNBRIG
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	6
Lung Neoplasms	5
Neoplasms	3
Carcinoma	2

Clinical Trial Locations for ALUNBRIG

Trials by Country

Trials by Country for ALUNBRIG
Location	Trials
United States	53
France	9
China	8
Spain	5
Italy	5

Trials by US State

Trials by US State for ALUNBRIG
Location	Trials
California	5
New York	3
Minnesota	2
Massachusetts	2
Maryland	2

Clinical Trial Progress for ALUNBRIG

Clinical Trial Phase

Clinical Trial Phase for ALUNBRIG
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for ALUNBRIG
Clinical Trial Phase	Trials
Recruiting	6
Not yet recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for ALUNBRIG

Sponsor Name

Sponsor Name for ALUNBRIG
Sponsor	Trials
National Cancer Institute (NCI)	4
Takeda	4
Ariad Pharmaceuticals	2

Sponsor Type

Sponsor Type for ALUNBRIG
Sponsor	Trials
Other	9
Industry	7
NIH	4

ALUNBRIG Market Analysis and Financial Projection

ALUNBRIG: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to ALUNBRIG

ALUNBRIG (brigatinib) is a tyrosine kinase inhibitor developed by Takeda Pharmaceuticals for the treatment of anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). Here, we delve into the clinical trials, market analysis, and future projections for this significant therapeutic agent.

Clinical Trials Overview

Phase 1/2 Trial

The initial Phase 1/2 trial of ALUNBRIG was designed to evaluate its safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. This trial laid the groundwork for further clinical investigations[3].

Pivotal Phase 2 ALTA Trial

The Phase 2 ALTA trial investigated the efficacy and safety of ALUNBRIG in patients with ALK+ locally advanced or metastatic NSCLC who had progressed on crizotinib. This trial demonstrated clinically meaningful response rates, including overall response rates (ORR) and duration of response (DOR), as evaluated by an Independent Review Committee (IRC)[4].

Phase 3 ALTA-1L Trial

The Phase 3 ALTA-1L trial was a global, randomized, open-label trial comparing ALUNBRIG to crizotinib in patients with ALK+ locally advanced or metastatic NSCLC who had not received prior treatment with an ALK inhibitor. This trial met its primary endpoint, showing a statistically significant improvement in progression-free survival (PFS) for ALUNBRIG over crizotinib. Notably, ALUNBRIG reduced the risk of intracranial disease progression or death by 69% in patients with baseline brain metastases[1][3].

Additional Trials

Other ongoing and completed trials include the Phase 2 J-ALTA trial in Japanese patients who progressed on alectinib, the Phase 2 ALTA 2 trial evaluating ALUNBRIG in patients who progressed on alectinib or ceritinib, and the Phase 3 ALTA 3 trial comparing ALUNBRIG to alectinib in patients who progressed on crizotinib[3].

Efficacy and Safety Profile

Primary Endpoints

The ALTA-1L trial demonstrated that ALUNBRIG significantly improved PFS compared to crizotinib, with a hazard ratio indicating a reduced risk of disease progression or death. Secondary endpoints included objective response rate (ORR), intracranial ORR, intracranial PFS, and overall survival (OS)[1].

Safety Profile

The safety profile of ALUNBRIG from the ALTA-1L trial was consistent with the existing prescribing information, with no new safety concerns identified. Common treatment-emergent adverse events (TEAEs) Grade ≥3 included increased CPK, increased lipase, and hypertension[3].

Regulatory Approvals

FDA and EMA Approvals

ALUNBRIG received Breakthrough Therapy Designation from the FDA for treating patients with ALK+ NSCLC whose tumors are resistant to crizotinib and was granted Orphan Drug Designation for the treatment of ALK+, ROS1+, and EGFR+ NSCLC. The European Commission approved ALUNBRIG as a first-line treatment for ALK+ NSCLC based on the results of the ALTA-1L trial[1][3].

Market Analysis and Projections

Market Size and Growth

The global ALUNBRIG market is expected to grow significantly over the forecast period from 2025 to 2031. The market analysis includes historical data from 2019 to 2023 and projected data up to 2031. Key factors influencing the market include the drug's efficacy, safety profile, and competitive landscape[2].

Competitive Landscape

The ALK-positive NSCLC market is competitive, with other notable players including Pfizer's Xalkori and Roche's Alecensa. ALUNBRIG has demonstrated superiority over Xalkori in clinical trials, reducing the risk of disease progression or death by 51% in newly diagnosed patients. Alecensa, however, remains a market leader, with significant sales and a strong market presence[5].

Value-Based Pricing

Takeda has launched a value-based pricing program for ALUNBRIG in collaboration with Point32Health, aiming to broaden access and stand behind the drug's value. This program is unique in its lack of eligibility limitations and offers a risk-sharing agreement to mitigate initial treatment concerns[5].

Regional Analysis

Global Reach

ALUNBRIG is currently approved in more than 40 countries, including the U.S., Canada, and the European Union. The European Commission's approval has expanded its marketing authorization to all European Union member states, as well as Norway, Liechtenstein, and Iceland[3].

Market Trends and Drivers

Increasing Demand for Targeted Therapies

The demand for targeted therapies in NSCLC is increasing, driven by their efficacy and safety profiles. ALUNBRIG's ability to treat patients with brain metastases effectively is a significant market driver[1].

Value-Based Pricing Models

The adoption of value-based pricing models is becoming more prevalent, especially in the oncology sector. Takeda's initiative with ALUNBRIG sets a precedent for other pharmaceutical companies to follow[5].

Challenges and Opportunities

Competitive Market

The ALK-positive NSCLC market is highly competitive, with multiple drugs vying for market share. ALUNBRIG must continue to demonstrate its superiority through clinical trials and real-world data to maintain its position[5].

Expanding Indications

There is an opportunity for ALUNBRIG to expand its indications into other areas of NSCLC treatment, potentially increasing its market share and patient access[3].

Key Takeaways

• Clinical Trials: ALUNBRIG has demonstrated significant efficacy in Phase 3 trials, particularly in the ALTA-1L trial, showing improved PFS over crizotinib.
• Regulatory Approvals: Approved as a first-line treatment for ALK+ NSCLC in multiple regions, including the U.S. and EU.
• Market Analysis: Expected to grow significantly from 2025 to 2031, driven by its efficacy and value-based pricing models.
• Competitive Landscape: Faces competition from other ALK inhibitors like Xalkori and Alecensa but has shown clinical superiority in some aspects.

FAQs

Q: What is the primary endpoint of the Phase 3 ALTA-1L trial for ALUNBRIG?

A: The primary endpoint of the Phase 3 ALTA-1L trial was progression-free survival (PFS), which ALUNBRIG demonstrated to be significantly improved compared to crizotinib[1].

Q: How does ALUNBRIG's safety profile compare to crizotinib?

A: The safety profile of ALUNBRIG was generally consistent with the existing prescribing information, with no new safety concerns identified. Common adverse events included increased CPK, lipase, and hypertension[3].

Q: What is the value-based pricing program for ALUNBRIG?

A: Takeda launched a value-based pricing program for ALUNBRIG in collaboration with Point32Health, offering a risk-sharing agreement to broaden access and mitigate initial treatment concerns[5].

Q: Which regions have approved ALUNBRIG for marketing?

A: ALUNBRIG is approved in more than 40 countries, including the U.S., Canada, and the European Union, as well as Norway, Liechtenstein, and Iceland[3].

Q: How does ALUNBRIG compare to other ALK inhibitors in the market?

A: ALUNBRIG has demonstrated clinical superiority over Xalkori and is competitive with Alecensa, although Alecensa remains a market leader in terms of sales[5].

Sources

1. Takeda Announces Phase 3 Trial of ALUNBRIG® (brigatinib) Met Primary Endpoint - Takeda Oncology.
2. Alunbrig Market Report 2024 (Global Edition) - Cognitive Market Research.
3. European Commission Approves Takeda's ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ NSCLC - Takeda.
4. Efficacy Results in Patients Previously Treated With ALUNBRIG - Alunbrig.
5. Takeda launches value-based pricing program for lung cancer med Alunbrig - Fierce Pharma.