CLINICAL TRIALS PROFILE FOR OBINUTUZUMAB

Biosimilar Clinical Trials for obinutuzumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05704400 ↗	Efficacy of Anti-CD20 Ab Associated With Anti-CD38 in the Childhood Multidrug Dependent and Resistant Nephrotic Syndrome	Not yet recruiting	Istituto Giannina Gaslini	Phase 2	2023-03-01	Nephrotic syndrome is considered a disease caused by an interplay of immunological stimuli with adaptive immunity(CD80/CD40) as trigger and Treg in the mid between co-stimulatory molecules and effectors. The positive effect of drugs blocking CD20 maturation in SDNS suggests a main role of these cells in regulating the system. Multidrug dependent, multidrug resistant nephrotic syndrome as well as post transplant FSGS recurrence patients can be considered difficult to treat patients and the association of two drugs, one targeting CD20 and a targeting plasmacells can be use in order to block the stimulatory cascade at more sites.

All Clinical Trials for obinutuzumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00517530 ↗	A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)	Completed	Hoffmann-La Roche	Phase 1/Phase 2	2007-09-01	The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL). It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used. Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.
NCT00576758 ↗	GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma	Completed	Hoffmann-La Roche	Phase 2	2008-01-01	This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101 (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.
NCT00825149 ↗	A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma	Completed	Hoffmann-La Roche	Phase 1	2009-02-01	This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.
NCT01010061 ↗	CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)	Completed	Genentech, Inc.	Phase 3	2009-12-21	This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
NCT01010061 ↗	CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)	Completed	German CLL Study Group	Phase 3	2009-12-21	This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
NCT01010061 ↗	CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)	Completed	Hoffmann-La Roche	Phase 3	2009-12-21	This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

Clinical Trial Conditions for obinutuzumab

Condition Name

Condition Name for obinutuzumab
Intervention	Trials
Chronic Lymphocytic Leukemia	54
Follicular Lymphoma	24
Small Lymphocytic Lymphoma	21
Mantle Cell Lymphoma	18

Condition MeSH

Condition MeSH for obinutuzumab
Intervention	Trials
Lymphoma	124
Leukemia, Lymphocytic, Chronic, B-Cell	92
Leukemia, Lymphoid	75
Leukemia	67

Clinical Trial Locations for obinutuzumab

Trials by Country

Trials by Country for obinutuzumab
Location	Trials
Italy	192
Spain	147
Australia	119
Canada	113
France	84

Trials by US State

Trials by US State for obinutuzumab
Location	Trials
California	78
New York	70
Texas	63
Florida	46
Ohio	42

Clinical Trial Progress for obinutuzumab

Clinical Trial Phase

Clinical Trial Phase for obinutuzumab
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	4
PHASE2	39

Clinical Trial Status

Clinical Trial Status for obinutuzumab
Clinical Trial Phase	Trials
RECRUITING	112
Active, not recruiting	46
Not yet recruiting	44

Clinical Trial Sponsors for obinutuzumab

Sponsor Name

Sponsor Name for obinutuzumab
Sponsor	Trials
Hoffmann-La Roche	72
Genentech, Inc.	48
National Cancer Institute (NCI)	28

Sponsor Type

Sponsor Type for obinutuzumab
Sponsor	Trials
Industry	252
Other	227
NIH	28

Obinutuzumab: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 1, 2025

---

Introduction

Obinutuzumab, marketed as Gazyva or Gazyvaro, is a monoclonal antibody targeting CD20-positive B cells. Developed by Roche/Genentech, it plays a significant role in treating hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). This article provides an in-depth overview of current clinical trial developments, comprehensive market analysis, and projections to guide stakeholders in the pharmaceutical landscape.

---

Clinical Trials Update

Regulatory Approvals and Ongoing Investigations

Obinutuzumab received FDA approval in 2013 for first-line treatment of CLL in combination with chlorambucil, and subsequently for follicular lymphoma in combination with bendamustine and rituximab in 2017. Since then, numerous clinical trials have evaluated its efficacy, safety, and expanded indications.

Currently, over 20 active trials are registered globally, investigating obinutuzumab's potential across various hematological malignancies and autoimmune disorders. Notably:

• NATIONAL/REGIONAL TRIALS:
  • GADOLIN study (NCT01663602): Confirmed improved progression-free survival (PFS) in relapsed/refractory follicular lymphoma (FL). Results facilitated regulatory approval extensions.
  • GAUSS trial (NCT03508414): Assessed safety and efficacy in high-risk follicular lymphoma post-rituximab relapse.
• LINE OF TREATMENT STUDIES:
  • Trials evaluating obinutuzumab in combination with novel agents such as BTK inhibitors (e.g., ibrutinib) and BCL-2 inhibitors (e.g., venetoclax).
  • Trials exploring its use against emerging subtypes like mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL).

Innovations and Expanding Indications

Recent trials aim to expand obinutuzumab's utility in autoimmune diseases such as rheumatoid arthritis (RA) and multiple sclerosis (MS), although these are in early phases (Phase I/II). Furthermore, its combination with novel immunotherapies like CAR-T cells is under exploratory evaluation, aiming to improve response rates.

Safety and Efficacy Profile

The extensive clinical data affirm obinutuzumab's superior efficacy over rituximab in certain indications, notably through longer PFS and higher complete response rates (CR). However, adverse events such as infusion-related reactions and neutropenia remain concerns, emphasizing the importance of optimized dosing and supportive care.

---

Market Analysis

Current Market Dynamics

The global hematological oncology drug market is estimated at approximately USD 12 billion in 2022, with targeted monoclonal antibodies like obinutuzumab accounting for over 30% of revenue growth. The expanding application scope, reinforced by positive trial outcomes, continues to bolster market penetration.

In 2022, Roche reported global sales of Gazyva/Gazyvaro exceeding USD 2.8 billion, illustrating robust commercial performance. Key markets include North America (particularly the U.S.), Europe, and parts of Asia-Pacific, driven by high incidence rates of CLL and follicular lymphoma.

Competitive Landscape

Obinutuzumab's primary competitors are rituximab (Rituxan), obinutuzumab's closest therapeutic rival, and newer agents such as ofatumumab. While rituximab holds the dominant position due to established market presence, obinutuzumab has gained market share owing to its enhanced efficacy in specific settings.

Emerging biosimilars and generics threaten to commoditize monoclonal antibody therapies, but patent protections and clinical differentiation strategies sustain Roche's competitive edge. Notably, Roche's ongoing Clinical trials aim to reinforce its differentiated position through evidence of superior outcomes.

Market Drivers and Challenges

Drivers:

• Rising incidence of B-cell malignancies globally.
• Approval of combination regimens showing improved outcomes.
• Growing acceptance of targeted therapies over chemotherapy.

Challenges:

• High cost of monoclonal antibody treatments restricting access.
• Safety concerns and management of adverse effects.
• Competition from biosimilars and alternative biologics.

---

Projection and Future Outlook

Market Growth Forecast

The market for obinutuzumab and similar monoclonal antibodies is expected to grow at a CAGR of about 8-10% from 2023 to 2030. Factors contributing include:

• Expanded indications, including potential autoimmune uses.
• Increased adoption in developing markets due to rising healthcare infrastructure.
• Technological advances enabling more effective and safer formulations.

Roche aims to sustain and expand its market share by investing heavily in clinical research, particularly in combination therapies and novel indications.

Upcoming Commercial Milestones

• FDA and EMA approvals for new indications, including MCL, MZL, and autoimmune diseases, projected between 2024-2026.
• Post-marketing studies to demonstrate long-term safety and survival benefits.
• Partnerships with biotech firms for innovation in personalized medicine and combination regimens.

Potential Barriers and Opportunities

While biosimilar entry remains a threat, Roche’s strategic focus on demonstrating superiority in clinical outcomes, coupled with expanding indications, provides a pathway for sustained growth. Moreover, integrating obinutuzumab into personalized treatment algorithms presents substantial market opportunities.

---

Key Takeaways

• Obinutuzumab's clinical profile demonstrates significant advantages in specific hematological malignancies, particularly follicular lymphoma and CLL.
• Active clinical trials aim to broaden its applications, including autoimmune diseases and other B-cell tumors.
• The drug's market remains robust, with a promising outlook driven by expanding indications, combination therapies, and geographic reach.
• Competition from biosimilars and pricing pressures necessitate strategic innovation and clinical differentiation.
• Ongoing trials and regulatory filings are critical to maintaining market dominance through 2030.

---

FAQs

1. What is the primary mechanism of action of obinutuzumab?
Obinutuzumab is a glycoengineered, type II anti-CD20 monoclonal antibody that induces B-cell depletion via antibody-dependent cellular cytotoxicity (ADCC) and apoptosis, offering enhanced efficacy over earlier anti-CD20 therapies like rituximab.

2. How does obinutuzumab compare to rituximab in clinical efficacy?
Clinical trials, such as the GALLIUM study, indicate that obinutuzumab often achieves higher response rates, longer progression-free survival, and deeper remissions compared to rituximab in follicular lymphoma, although safety profiles differ.

3. What are the main safety concerns associated with obinutuzumab?
Infusion-related reactions, neutropenia, and infections are notable adverse events. Proper patient management and supportive care are essential to mitigate these risks.

4. Are there ongoing efforts to expand obinutuzumab into autoimmune disease treatments?
Yes, early-phase trials are exploring its efficacy in conditions like rheumatoid arthritis and multiple sclerosis, aiming to leverage its B-cell depleting capabilities in autoimmune modulation.

5. What is the outlook for obinutuzumab sales over the next decade?
Sales are projected to grow at a compound annual rate of approximately 8-10%, driven by regulatory approvals for new indications, combination strategies, and expanding markets, especially in emerging economies.

---

References

[1] Roche Press Release. "Gazyva receives FDA approval for CLL." 2014.
[2] European Medicines Agency. Gazyva summary of product characteristics. 2018.
[3] Martin P, et al. "Obinutuzumab in the treatment of follicular lymphoma." Blood Advances. 2020.
[4] GlobalData. Hematologic Oncology Drugs Market Report. 2022.
[5] ClinicalTrials.gov. "Obinutuzumab Trials." 2023.