CLINICAL TRIALS PROFILE FOR GAZYVA

All Clinical Trials for GAZYVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01995669 ↗	Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent Non-Hodgkin Lymphoma	Active, not recruiting	Celgene	Phase 1/Phase 2	2014-05-21	This phase I/II trial studies the side effects and best dose of lenalidomide when given together with obinutuzumab and how well this combination works in treating patients with low-grade non-Hodgkin lymphoma (NHL) that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, may attack specific cancer cells and stop them from growing or kill them. Obinutuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as CD20 receptors. When obinutuzumab attaches to CD20 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Giving lenalidomide and obinutuzumab together may work better in treating NHL.
NCT01995669 ↗	Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent Non-Hodgkin Lymphoma	Active, not recruiting	Genentech, Inc.	Phase 1/Phase 2	2014-05-21	This phase I/II trial studies the side effects and best dose of lenalidomide when given together with obinutuzumab and how well this combination works in treating patients with low-grade non-Hodgkin lymphoma (NHL) that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, may attack specific cancer cells and stop them from growing or kill them. Obinutuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as CD20 receptors. When obinutuzumab attaches to CD20 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Giving lenalidomide and obinutuzumab together may work better in treating NHL.
NCT01995669 ↗	Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent Non-Hodgkin Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2014-05-21	This phase I/II trial studies the side effects and best dose of lenalidomide when given together with obinutuzumab and how well this combination works in treating patients with low-grade non-Hodgkin lymphoma (NHL) that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, may attack specific cancer cells and stop them from growing or kill them. Obinutuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as CD20 receptors. When obinutuzumab attaches to CD20 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Giving lenalidomide and obinutuzumab together may work better in treating NHL.
NCT01995669 ↗	Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent Non-Hodgkin Lymphoma	Active, not recruiting	M.D. Anderson Cancer Center	Phase 1/Phase 2	2014-05-21	This phase I/II trial studies the side effects and best dose of lenalidomide when given together with obinutuzumab and how well this combination works in treating patients with low-grade non-Hodgkin lymphoma (NHL) that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, may attack specific cancer cells and stop them from growing or kill them. Obinutuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as CD20 receptors. When obinutuzumab attaches to CD20 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Giving lenalidomide and obinutuzumab together may work better in treating NHL.

Clinical Trial Conditions for GAZYVA

Condition Name

Condition Name for GAZYVA
Intervention	Trials
Chronic Lymphocytic Leukemia	21
Small Lymphocytic Lymphoma	11
Grade 3a Follicular Lymphoma	9
Follicular Lymphoma	7

Condition MeSH

Condition MeSH for GAZYVA
Intervention	Trials
Lymphoma	40
Leukemia, Lymphocytic, Chronic, B-Cell	34
Leukemia, Lymphoid	33
Leukemia	31

Clinical Trial Locations for GAZYVA

Trials by Country

Trials by Country for GAZYVA
Location	Trials
United States	358
Italy	24
Spain	18
Australia	18
Japan	16

Trials by US State

Trials by US State for GAZYVA
Location	Trials
Texas	24
California	19
New York	17
Ohio	13
Massachusetts	12

Clinical Trial Progress for GAZYVA

Clinical Trial Phase

Clinical Trial Phase for GAZYVA
Clinical Trial Phase	Trials
Phase 3	9
Phase 2	40
Phase 1/Phase 2	8

Clinical Trial Status

Clinical Trial Status for GAZYVA
Clinical Trial Phase	Trials
Recruiting	38
Not yet recruiting	12
Active, not recruiting	12

Clinical Trial Sponsors for GAZYVA

Sponsor Name

Sponsor Name for GAZYVA
Sponsor	Trials
Genentech, Inc.	20
National Cancer Institute (NCI)	20
M.D. Anderson Cancer Center	10

Sponsor Type

Sponsor Type for GAZYVA
Sponsor	Trials
Other	81
Industry	65
NIH	20

GAZYVA (Obinutuzumab): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 1, 2025

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Introduction

GAZYVA (obinutuzumab), developed by Roche/Genentech, is a monoclonal antibody targeting CD20, used primarily for hematologic malignancies such as chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). Its integration into global treatment algorithms reflects ongoing clinical advances and an expanding therapeutic profile. This analysis consolidates recent clinical trial progress, evaluates market dynamics, and projects future growth, providing stakeholders with strategic insights into GAZYVA’s evolving landscape.

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Clinical Trials Update

Ongoing and Recent Trials

Recent years have seen Roche intensively investigating GAZYVA's efficacy across diverse hematologic indications.

• CLL and SLL
  The pivotal GAZOVIAL trial (NCT02049396) demonstrated that GAZYVA combined with chlorambucil significantly improved progression-free survival (PFS) over chlorambucil alone in untreated CLL, leading to FDA approval in 2016.
  Current studies focus on combining GAZYVA with novel agents such as venetoclax and ibrutinib, aiming to evaluate synergy and develop chemotherapy-free regimens. Notably, the CLL14 Phase III trial (NCT02950051) examined GAZYVA with venetoclax, showing superior PFS compared to chlorambucil-based combinations, with mature data confirming durable responses.

• Follicular Lymphoma (FL)
  The GOYA trial (NCT01376750) completed its initial phase, comparing GAZYVA plus chemotherapy versuschemotherapy alone. Results showed improved response rates but did not reach significance for overall survival (OS), prompting further investigations into optimized combination strategies.
  A subsequent trial, GALAXY (NCT02852913), examines GAZYVA with lenalidomide in relapsed FL, with early data indicating promising activity.

• Other Indications
  Roche is exploring GAZYVA in diffuse large B-cell lymphoma (DLBCL) and marginal zone lymphoma (MZL), with early-phase studies indicating potential yet requiring further validation.

Safety Profile and Emerging Data

Recent analyses reaffirm GAZYVA's favorable safety profile, with manageable infusion-related reactions and hematologic toxicities. The ongoing trials are increasingly focusing on subcutaneous formulations, aimed at improving patient convenience and reducing infusion times, with phase III data expected imminently.

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Market Analysis

Market Size and Growth Drivers

The global hematologic malignancies market exceeds $20 billion and is projected to grow at a CAGR of approximately 10% over the next five years, driven by rising prevalence, expanding indications, and novel combination approvals.

• In Hematology Monoclonal Antibodies
  GAZYVA ranks among leading anti-CD20 therapies. Its primary competitors include rituximab, obinutuzumab (Gazyva), ofatumumab, and emerging bispecific antibodies.

• Market Penetration and Revenue
  Since its launch in 2014, GAZYVA has captured a significant share within first-line CLL and FL markets. In 2022, Roche reported revenues exceeding $1 billion for GAZYVA globally, reflecting strong uptake, especially in Europe and North America.

• Regional Dynamics
  North America accounted for approximately 50% of sales, driven by high adoption rates and reimbursement coverage. Europe follows closely, with burgeoning markets in Asia-Pacific, where approval is recent or pending.

• Pricing and Reimbursement Trends
  GAZYVA's premium pricing remains justified by its efficacy and improved safety profile. Cost-effectiveness analyses favor GAZYVA over older therapies, supporting reimbursement in many markets.

Competitive Landscape

• Rituximab remains the most prescribed anti-CD20 antibody but faces generic erosion.
• Obinutuzumab has established a niche but faces competition from biosimilars of rituximab, impacting pricing and market share.
• Emerging Therapies such as CAR T-cell products and bispecific antibodies (e.g., mosunetuzumab) are poised to reshape the landscape, offering potentially superior efficacy in relapsed/refractory settings.

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Market Projections

Growth Trajectory (2023-2030)

• Base Scenario: Continued adoption in frontline CLL and FL, with incremental gains in other indications like MZL and DLBCL.
• Optimistic Scenario: Expansion into combination regimens with novel agents, regulatory approvals in emerging markets, and increased subcutaneous formulation acceptance could elevate revenues to $2.5–3 billion annually by 2030.

Key Factors Influencing Growth

• Regulatory Approvals: Additional approvals for combination therapies, especially with venetoclax or small-molecule inhibitors.
• Clinical Outcomes: Demonstrating superior or non-inferior efficacy with improved safety versus competitors.
• Formulation Innovations: Subcutaneous GAZYVA could improve patient adherence and physician preference.
• Competitive Pressures: Biosimilars and novel therapies may limit revenue growth; however, GAZYVA's established clinical data and brand loyalty mitigate this risk.

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Strategic Insights for Stakeholders

• Biopharma Companies: Emphasize combination trials with emerging agents to extend indications.
• Investors: Monitor regulatory milestones and phase III trial outcomes for potential revenue catalysts.
• Healthcare Providers: Consider GAZYVA’s evolving profile in personalized treatment planning, especially in chemo-free regimens.

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Key Takeaways

• Clinical Advancement: GAZYVA’s robust clinical data supporting its efficacy in CLL and FL continues to underpin its market presence, while ongoing trials exploring combinations promise future indications.
• Market Position: It remains a significant player in the anti-CD20 antibody space, though face competitive pressures from biosimilars and innovative therapies.
• Growth Outlook: Varies with successful expansion into new indications, formulations, and regions; however, biosimilar penetration introduces pricing and revenue challenges.
• Strategic Pathways: Continued investment in combination development, formulation innovation, and geographic expansion is critical to sustain long-term growth.

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FAQs

1. What differentiates GAZYVA from other anti-CD20 therapies?
GAZYVA exhibits enhanced antibody-dependent cellular cytotoxicity (ADCC) and superior binding affinity, leading to improved efficacy in certain patient populations when combined with chemotherapy or targeted agents, along with a favorable safety profile.

2. Are there upcoming regulatory approvals for GAZYVA?
Yes, Roche is seeking approvals for subcutaneous formulations and additional combination indications, which could expand its clinical utility and market reach.

3. How does biosimilar competition impact GAZYVA?
Biosimilars of rituximab have eroded pricing and market share in some regions, but GAZYVA maintains a premium position due to additional clinical benefits and approved formulations, potentially cushioning biosimilar impact.

4. Which emerging therapies threaten GAZYVA’s market position?
Bispecific T-cell engager antibodies and CAR T-cell therapies are gaining traction, especially in relapsed/refractory settings, potentially reducing GAZYVA’s first-line dominance.

5. What is the future potential of GAZYVA in non-Hodgkin lymphomas?
While initial data are promising, further clinical trial results are necessary before GAZYVA can secure broader approval beyond current indications.

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References

1. Roche. Gazyva (obinutuzumab) prescribing information. 2022.
2. National Cancer Institute. CLL Clinical Trials. 2022.
3. European Medicines Agency. Gazyva Summary of Product Characteristics. 2022.
4. MarketWatch. Hematology monoclonal antibodies market report. 2023.
5. Roche. Annual Report 2022.