CLINICAL TRIALS PROFILE FOR BREYANZI

All Clinical Trials for BREYANZI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05359211 ↗	NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma	Not yet recruiting	Nektar Therapeutics	Phase 1	2022-05-01	This phase Ib trial studies the effects of NKTR-255 in combination with chimeric antigen (CAR)-T cell therapy and to see how well they work in treating patients with large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Lisocabtagene maraleucel is a CAR-T cell product that consists of genetically engineered T cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 together with lisocabtagene maraleucel may work better in treating large B-cell lymphoma than either drug alone.
NCT05359211 ↗	NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma	Not yet recruiting	Fred Hutchinson Cancer Center	Phase 1	2022-05-01	This phase Ib trial studies the effects of NKTR-255 in combination with chimeric antigen (CAR)-T cell therapy and to see how well they work in treating patients with large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Lisocabtagene maraleucel is a CAR-T cell product that consists of genetically engineered T cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 together with lisocabtagene maraleucel may work better in treating large B-cell lymphoma than either drug alone.
NCT05583149 ↗	Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas	Not yet recruiting	AstraZeneca	Phase 2	2022-10-01	This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma. This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce
NCT05583149 ↗	Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas	Not yet recruiting	Jeremy Abramson, MD	Phase 2	2022-10-01	This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma. This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce
NCT05633615 ↗	Testing Drug Treatments After CAR T-cell Therapy in Patients With Diffuse Large B-cell Lymphoma That Has Come Back or Not Responded to Treatment	Not yet recruiting	National Cancer Institute (NCI)	Phase 2	2022-12-04	This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.

Clinical Trial Conditions for BREYANZI

Condition Name

Condition Name for BREYANZI
Intervention	Trials
Refractory Transformed Chronic Lymphocytic Leukemia	2
Grade 3b Follicular Lymphoma	2
Recurrent Transformed Chronic Lymphocytic Leukemia	2
Refractory Diffuse Large B-Cell Lymphoma	2

Condition MeSH

Condition MeSH for BREYANZI
Intervention	Trials
Lymphoma	5
Lymphoma, Large B-Cell, Diffuse	4
Lymphoma, B-Cell	4
Lymphoma, Follicular	3

Clinical Trial Locations for BREYANZI

Trials by Country

Trials by Country for BREYANZI
Location	Trials
United States	18
Germany	4
France	3

Trials by US State

Trials by US State for BREYANZI
Location	Trials
Missouri	2
Ohio	2
California	2
Massachusetts	2
Washington	2

Clinical Trial Progress for BREYANZI

Clinical Trial Phase

Clinical Trial Phase for BREYANZI
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for BREYANZI
Clinical Trial Phase	Trials
Not yet recruiting	5
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for BREYANZI

Sponsor Name

Sponsor Name for BREYANZI
Sponsor	Trials
National Cancer Institute (NCI)	2
Southwest Oncology Group	1
City of Hope Medical Center	1

Sponsor Type

Sponsor Type for BREYANZI
Sponsor	Trials
Other	6
Industry	4
NIH	2

Clinical Trials Update, Market Analysis, and Projection for BREYANZI (Lisocabtagene Maraleucel)

Last updated: November 24, 2025

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Introduction

BREYANZI (lisocabtagene maraleucel) is a chimeric antigen receptor T-cell (CAR-T) therapy developed by Bristol-Myers Squibb (BMS) for the treatment of relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma, and primary mediastinal B-cell lymphoma. Since its debut, BREYANZI has gained prominence within the rapidly evolving CAR-T landscape. This report provides an in-depth analysis of recent clinical trial updates, current market dynamics, and future growth projections for BREYANZI.

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Clinical Trials Update

Recent Clinical Data and Approval Milestones

BREYANZI received FDA approval in February 2021 for adult patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma transformed to DLBCL. The approval was based predominantly on the pivotal TRANSCEND NHL 001 trial, which demonstrated significant efficacy and manageable safety profiles.

TRANSCEND NHL 001 Trial Highlights:

• Efficacy: ORR of 73%, with a CR rate of 53% in evaluable patients.
• Durability: Median follow-up of 17 months showed durable responses, with median duration of response (DOR) not reached.
• Safety: Common adverse events included cytokine release syndrome (CRS; 78%) and neurotoxicity (32%), predominantly grade 1-2. Severe adverse events (grade ≥3 CRS and neurotoxicity) occurred in 2-3% of patients.

Ongoing and Planned Clinical Trials

• ZUMA-12 (NCT03761056): A phase 2 trial evaluating BREYANZI as a first-line therapy in high-risk large B-cell lymphoma patients. Interim results suggest promising efficacy, indicating potential for reduced treatment barriers and expanded indications.

• TRANSCEND WORLD (NCT04614948): A global trial assessing BREYANZI’s safety and efficacy across diverse demographics and healthcare settings, aiming to support broader approvals.

• Comparative Studies: Head-to-head evaluations with competitors like Kymriah (Novartis) and Tecartus (Gilead) are underway to delineate positioning and identify benefit-risk profiles.

Regulatory Developments

• FDA and EMA Approvals: BREYANZI is FDA-approved, with ongoing applications in other jurisdictions. The company is actively seeking expansions into earlier lines of therapy and additional lymphoma subtypes.

• Label Updates: Recent updates include real-world data incorporation, affirming efficacy in broader patient populations with comorbidities.

Safety and Manufacturing Enhancements

BMS has focused on refining manufacturing processes to reduce vein-to-vein time, currently averaging 22 days, mitigating relapse risks associated with delayed treatment. Additionally, efforts are underway to reduce neurotoxicity incidences through optimized dosing.

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Market Analysis

Current Market Landscape

The CAR-T therapeutic landscape for large B-cell lymphomas is highly competitive, dominated by three approved therapies:

1. Yescarta (Kymriah by Gilead Sciences)
2. Tecartus (Gilead Sciences)
3. BREYANZI (Bristol-Myers Squibb)

While Yescarta was first approved in 2017, BREYANZI gained approval in 2021, positioning itself as a differentiated, potentially more tolerable option with lower neurotoxicity rates.

Market Penetration and Adoption

• Sales Performance: BMS reported initial sales exceeding $300 million in 2022, driven by strong demand in North America.
• Physician Adoption: Growing familiarity with BREYANZI’s safety profile has expanded its use in community oncology settings, previously hesitant due to management complexity.

Competitive Advantages

• Manufacturing Efficiency: BREYANZI’s streamlined production reduces vein-to-vein times, addressing logistical bottlenecks common in CAR-T therapies.
• Safety Profile: Lower neurotoxicity rates enhance usability, especially among older or comorbid patients.
• Indication Expansion: Pursuit of earlier-line treatments and combination protocols could significantly broaden its market share.

Market Challenges

• High Cost & Reimbursement: Price points hover around $373,000 per treatment, with variable insurance coverage posing barriers.
• Manufacturing Capacity: Scaling up to meet demand presents ongoing logistical and regulatory hurdles.

Market Projections

Analysts forecast that the global CAR-T therapies market will grow from approximately $1.2 billion in 2022 to over $8 billion by 2030, with BREYANZI capturing an increasing share driven by expanding indications and improved access. Its projected compound annual growth rate (CAGR) could reach 25-30% over the next five years, contingent on regulatory approvals and market penetration strategies.

Future Projections

Growth Drivers

• Expanded Indications: Trials exploring BREYANZI as a first-line therapy could significantly inflate sales, tapping into a larger patient population.
• Regulatory Pathways: Regulatory approvals in Europe, Asia, and emerging markets will unlock new revenue streams.
• Combination Therapies: Integration with immune checkpoint inhibitors or targeted agents may enhance efficacy, opening new treatment algorithms.
• Manufacturing Innovations: Advances such as automated manufacturing aim to reduce costs, increase capacity, and improve patient access.

Potential Market Challenges

• Competitive Intensity: Innovations from competitors, including next-generation CAR-Ts and off-the-shelf allogeneic therapies, threaten market share.
• Cost Management: Payer negotiations will remain critical to ensure reimbursement and affordability.
• Regulatory Delays: As with all gene therapies, delays in approval processes or safety concerns could impact projections.

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Conclusion

BREYANZI’s clinical advancements and strategic manufacturing improvements position it as a formidable player in CAR-T therapy for large B-cell lymphomas. Its safety profile and efficient production model differentiate it within a competitive landscape poised for substantial growth. Continued clinical trials and potential indications expansion could propel BREYANZI's revenues, making it a critical asset for BMS’s hematology portfolio. Stakeholders should monitor evolving data, competitive dynamics, and regulatory developments to optimize market positioning.

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Key Takeaways

• Clinical Effectiveness: BREYANZI demonstrates high response rates and durable remissions in refractory large B-cell lymphomas, supported by robust trial data.
• Safety Profile: Despite risks of CRS and neurotoxicity, BREYANZI exhibits relatively lower neurotoxicity rates compared to rivals, facilitating broader clinical adoption.
• Market Dynamics: Positioned as a differentiation within a growing CAR-T market, BREYANZI’s manufacturing efficiencies and safety advantages offer competitive edges.
• Expansion Opportunities: Trials exploring earlier-line use and combination regimens could exponentially increase its market share.
• Growth Forecast: Industry analysts project CAGR of 25-30% over the next five years, driven by expanding indications, regulatory approvals, and manufacturing innovations.

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FAQs

1. What distinguishes BREYANZI from other CAR-T therapies?
BREYANZI’s streamlined manufacturing process yields shorter vein-to-vein times, and its safety profile, particularly lower neurotoxicity, provides a clinical advantage, especially for less fit or older patients.

2. Are there ongoing studies to expand BREYANZI’s indications?
Yes. Trials such as ZUMA-12 aim to evaluate its efficacy as a first-line therapy in high-risk patients. Broader indications could significantly enhance market size.

3. What are the main hurdles for BREYANZI’s market growth?
High treatment costs, reimbursement challenges, manufacturing capacity limits, and stiff competition from newer or off-the-shelf therapies remain primary obstacles.

4. How has BREYANZI performed commercially since its approval?
Initial sales exceeded expectations, reflecting strong institutional adoption. Expansion into community settings and direct-to-patient approaches are expected to further elevate sales.

5. What is the outlook for BREYANZI in emerging markets?
Regulatory approval in Europe and Asia is in progress. When achieved, these markets could substantially contribute to sales growth given rising lymphoma incidences and unmet needs.

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References

[1] Bristol-Myers Squibb. (2022). BREYANZI (lisocabtagene maraleucel) Prescribing Information.
[2] National Cancer Institute. (2022). CAR-T Cell Therapy for Non-Hodgkin Lymphoma.
[3] MarketWatch. (2023). CAR-T therapy market projections and competitive analysis.
[4] FDA. (2021). Approval Letter for BREYANZI.
[5] Global Data. (2022). Oncology Market Forecasts and CAR-T Therapy Segment Insights.