CLINICAL TRIALS PROFILE FOR BRUKINSA

All Clinical Trials for Brukinsa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03145064 ↗	Study of BTK Inhibitor Zanubrutinib in Participants With Relapsed/Refractory Non-GCB Type Diffuse Large B Cell Lymphoma	Completed	BeiGene	Phase 2	2017-06-30	Screening (up to 28 days); daily treatment until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow-up, or study termination from sponsor; treatment (up to 2 years), safety follow-up (30 days); survival follow-up until data cutoff for final analysis.
NCT03332017 ↗	A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma	Active, not recruiting	BeiGene	Phase 2	2017-11-15	The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.
NCT03336333 ↗	A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL	Recruiting	BeiGene	Phase 3	2017-11-02	To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival.
NCT04002297 ↗	Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma	Recruiting	BeiGene	Phase 3	2019-08-21	This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
NCT04116437 ↗	Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment	Recruiting	BeiGene	Phase 2	2019-10-15	The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.
NCT04382586 ↗	Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants	Completed	BeiGene	Phase 2	2020-07-06	The primary objective of this study is to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress.
NCT04458610 ↗	Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2020-05-26	This phase II trial studies how well zanubrutinib and rituximab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma for which the patient has not received treatment in the past (previously untreated). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The study is being done to find out if zanubrutinib combined with rituximab can help control previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Clinical Trial Conditions for Brukinsa

Condition Name

Condition Name for Brukinsa
Intervention	Trials
Small Lymphocytic Lymphoma	3
Healthy Volunteers	2
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	2
Recurrent Transformed B-Cell Non-Hodgkin Lymphoma	2

Condition MeSH

Condition MeSH for Brukinsa
Intervention	Trials
Lymphoma	17
Lymphoma, B-Cell	7
Leukemia, Lymphoid	7
Leukemia, Lymphocytic, Chronic, B-Cell	7

Clinical Trial Locations for Brukinsa

Trials by Country

Trials by Country for Brukinsa
Location	Trials
United States	92
China	27
Australia	22
France	14
Japan	11

Trials by US State

Trials by US State for Brukinsa
Location	Trials
Texas	7
Illinois	6
Florida	6
New York	5
Nevada	5

Clinical Trial Progress for Brukinsa

Clinical Trial Phase

Clinical Trial Phase for Brukinsa
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	16

Clinical Trial Status

Clinical Trial Status for Brukinsa
Clinical Trial Phase	Trials
Not yet recruiting	12
Recruiting	10
Completed	3

Clinical Trial Sponsors for Brukinsa

Sponsor Name

Sponsor Name for Brukinsa
Sponsor	Trials
BeiGene	17
National Cancer Institute (NCI)	4
Peking Union Medical College Hospital	2

Sponsor Type

Sponsor Type for Brukinsa
Sponsor	Trials
Industry	21
Other	14
NIH	4

Brukinsa: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Brukinsa

Brukinsa, also known as zanubrutinib, is a potent and selective inhibitor of Bruton's tyrosine kinase (BTK), developed by BeiGene. It has been approved for the treatment of various B-cell malignancies, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenström’s macroglobulinemia (WM).

Clinical Trials and Efficacy

Trial Design and Outcomes

Brukinsa's efficacy and safety were established through several clinical trials. Two key trials include:

• Trial 1: A Phase 2 open-label, multicenter, single-arm trial that enrolled patients with MCL who had received at least one prior therapy. Patients received Brukinsa orally at a dose of 160 mg twice daily until disease progression or unacceptable toxicity. The trial showed a significant overall response rate (ORR) with about 84% of patients experiencing complete or partial shrinkage of their tumors[1].

• Trial 2: A Phase 1/2 open-label, dose-escalation, global, multicenter, single-arm trial that included patients with B-cell malignancies, including MCL. Patients received Brukinsa at doses of 160 mg twice daily or 320 mg daily. This trial also demonstrated promising efficacy and tolerability[1].

Long-Term Efficacy Data

Recent updates from the SEQUOIA study, a Phase 3 trial, have reinforced Brukinsa's durable efficacy. With a median follow-up of 61.2 months, the study showed that Brukinsa reduced the risk of progression or death by 71% compared to bendamustine-rituximab in patients with treatment-naïve CLL. At 60 months, the progression-free survival (PFS) rates were 75.8% for Brukinsa and 40.1% for the comparator arm[4].

Safety Profile

Brukinsa has demonstrated a favorable safety profile compared to other BTK inhibitors like ibrutinib. It has a lower incidence of adverse events such as atrial fibrillation, hypertension, and diarrhea. However, rare risks like interstitial lung disease (ILD) have been identified and are included in the drug's warnings and precautions[3].

Market Analysis

Current Market Size and Growth

The global Brukinsa market was valued at USD 565 million in 2022 and is expected to grow at a strong Compound Annual Growth Rate (CAGR) of around 6% during the forecast period from 2023 to 2030. This growth is driven by the increasing prevalence of acute lymphoblastic leukemia (ALL) and CLL, as well as growing awareness of the drug's efficacy and safety[2].

Regional Market Dynamics

The Asia Pacific region dominated the Brukinsa market in 2022, driven by the large population and increasing prevalence of ALL and CLL in this region. Other significant markets include North America and Europe, where Brukinsa has gained substantial market share, particularly in the treatment of CLL and WM[2].

End-User Segmentation

The market is segmented based on end-users, including hospitals, clinics, and others. Clinics are expected to grow with a high CAGR during the forecast period, driven by the increasing demand for effective treatment options for ALL and CLL[2].

Market Projections

Sales Performance

In the first quarter of 2024, U.S. sales of Brukinsa totaled $351 million, representing a 153% growth over the prior-year period. In Europe, sales totaled $67 million, with a growth rate of 243%, driven by continued gains in market share and additional reimbursements in countries like France[5].

Competitive Landscape

The market is highly competitive, with key players including Bristol Myers Squibb, Celgene, Novartis, Pfizer, and Merck. However, BeiGene has solidified its leadership in the BTK inhibitor class, particularly in CLL, with Brukinsa emerging as the leader in new patient starts in both frontline and relapsed/refractory CLL[2].

Regulatory Approvals and Submissions

Brukinsa has undergone expedited review processes for various indications. For instance, the request for priority status for the treatment of WM was accepted due to substantial evidence of clinical effectiveness and an improved benefit-risk profile over existing therapies[3].

Future Outlook and Pipeline

Ongoing and Future Trials

Ongoing trials, such as the SEQUOIA study, continue to provide long-term efficacy and safety data, further solidifying Brukinsa's position in the treatment landscape. Additionally, BeiGene is advancing its pipeline with new assets like sonrotoclax, a next-generation BCL2 inhibitor, which shows promising results in combination with Brukinsa for treatment-naïve CLL[4].

Market Expansion

The market for Brukinsa is expected to expand further with increasing reimbursements and approvals in various regions. The drug's broad label and favorable safety profile are key factors driving its adoption in both frontline and relapsed/refractory settings[5].

Key Takeaways

• Efficacy and Safety: Brukinsa has demonstrated significant efficacy in clinical trials, with a favorable safety profile compared to other BTK inhibitors.
• Market Growth: The global market for Brukinsa is expected to grow at a CAGR of around 6% from 2023 to 2030, driven by increasing prevalence of ALL and CLL.
• Regional Dynamics: The Asia Pacific region is a major market, with significant growth also observed in North America and Europe.
• Sales Performance: Brukinsa has shown strong sales growth in the U.S. and Europe, solidifying its leadership in the BTK inhibitor class.
• Future Outlook: Ongoing and future trials, along with pipeline advancements, are expected to further expand Brukinsa's market presence.

FAQs

What is Brukinsa used for?

Brukinsa (zanubrutinib) is used to treat various B-cell malignancies, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenström’s macroglobulinemia (WM).

What are the key benefits of Brukinsa in clinical trials?

In clinical trials, Brukinsa has shown significant tumor response rates, with about 84% of patients experiencing complete or partial shrinkage of their tumors. It also reduces the risk of progression or death by 71% compared to bendamustine-rituximab in CLL patients[1][4].

What is the current market size of Brukinsa?

The global Brukinsa market was valued at USD 565 million in 2022 and is expected to grow at a CAGR of around 6% from 2023 to 2030[2].

Which regions are driving the growth of the Brukinsa market?

The Asia Pacific region is a major driver, followed by North America and Europe, where Brukinsa has gained significant market share[2].

What are the safety concerns associated with Brukinsa?

While Brukinsa has a favorable safety profile, rare risks such as interstitial lung disease (ILD) have been identified. It also has a lower incidence of adverse events like atrial fibrillation, hypertension, and diarrhea compared to other BTK inhibitors[3].

How is Brukinsa performing in terms of sales?

In the first quarter of 2024, U.S. sales of Brukinsa totaled $351 million, representing a 153% growth over the prior-year period. European sales also showed significant growth, totaling $67 million with a 243% increase[5].

Sources

1. FDA Drug Trials Snapshots: BRUKINSA - FDA
2. Brukinsa Market: Current Analysis and Forecast (2023-2030) - UnivDatos
3. Summary Basis of Decision for Brukinsa - Health Products and Food Branch
4. BeiGene Advances Leadership in CLL at ASH 2024 with New Data From Its Hematology Franchise Including BRUKINSA® and Novel Pipeline Assets - BeiGene
5. BeiGene Reports First Quarter 2024 Financial Results and Business Updates - BeiGene