CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [6]

Active Indication

Lupus NephritisCD20 Positive B-Cell Chronic Lymphocytic LeukemiaCD20 positive Follicular Lymphoma+ [47]

Inactive Indication

CD20 positive Diffuse Large B-Cell LymphomaCD20 positive Hematologic NeoplasmsGranulomatosis With Polyangiitis+ [16]

Originator Organization

Roche Glycart AG

Active Organization

F. Hoffmann-La Roche Ltd.

Roche Diagnostics GmbH

Acerta Pharma BV

+ [18]

Inactive Organization

Janssen-Cilag Ltd.Janssen-Cilag GmbH

Roche Nederland BV

License Organization

Biogen, Inc.

Nippon Shinyaku Co., Ltd.

Genentech, Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (01 Nov 2013),

Chronic Lymphocytic Leukemia

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China)

Structure/Sequence

Sequence Code 68713L

Source: *****

Sequence Code 9699891H

Source: *****

358

Clinical Trials associated with Obinutuzumab

NCT07634289

/ Not yet recruitingPhase 2IIT

Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma: The Phase II Radio-GLO Study

The goal of this clinical trial is to see if a new combination of standard of care radiotherapy treatment prior to administering the study drugs obinutuzumab and glofitamab in relapsed/refractory Diffuse Large B Cell Lymphoma patients is effective. The main question it aims to answer is:
If you are able to tolerate the study treatments, and whether your cancer responds to the study treatment, compared with other reported studies of standard care treatments.
Participants will have three parts they need to complete over a 5 year period.
* Screening period over a 28 day period
* Treatment period - Radiotherapy followed by 12 treatment cycles every three weeks (total time approx. 37 weeks)
* Follow up, up to 4 years. Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and 18F-Granzyme B for evaluation of the impact of radiotherapy plus glofitamab with relapsed diffuse large B-cell lymphoma.

Start Date01 Dec 2026

Sponsor / Collaborator

Olivia Newton-John Cancer Research Institute

[+4]

NCT07624799

/ Not yet recruitingPhase 2IIT

Fixed Duration Treatment With Combined Pirtobrutinib and Short Course Immuno-chemotherapy in Fit Patients With Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL). A Phase II FILO Trial

The evidence base in support of fixed-duration, first-line approaches in medically fit patients with CLL is clearly strengthening, whether through combining targeted agents with immunochemotherapy or through chemotherapy-free combinations. The long-term PB MRD response rates with the investagators fixed-duration (15-month) immunochemotherapy approach remain the best to date, even compared to the new targeted agent combinations of ibrutinib-venetoclax or obinutuzumab-venetoclax.
The investigators' phase 2 ICLL07 trial in previously untreated fit CLL patients with a fixed-duration immunochemotherapy approach (with 4 cycles of FC-obinutuzumab and chemosparing strategy) carries a low risk for short and long term toxicities which still exist, including cardiac toxicities probably related to BTK inhibitors, moreover, two patients experienced treatment related myelodysplastic syndrome or acute myeloid leukemia beyond the end of treatment. Follow-up at 5,5 years from treatment start showed a persistent PB MRD benefit beyond end of treatment, high survival rates, and low long term toxicity with no difference in the durability of MRD response between the mutated and unmutated IGHV patients.
The investigators aim to explore the safety and efficacy of a fixed duration strategy combining a new BTK inhibitor with a favorable safety profile and a limited number of ICT courses.
The main goals and concerns are:
i) to ensure deep response and long lasting MRD ii) to reduce the duration of BTKi exposure and the risk of clonal evolution with the appearance of deleterious mutations iii) to limit the risk of hematopoietic secondary cancers (MDS/AML) by excluding patients in whom clonal hematopoiesis of undetermined potential (CHIP) is detected before inclusion and decreasing the number of courses of chemotherapy to 3 cycles. Moreover, patients with TP53 abnormalities will be excluded with a lower cut off (1% versus 10% in the previous studies) iv) to limit the risk of BTKi toxicity by using a non-covalent BTKi

Start Date01 Sep 2026

Sponsor / Collaborator-

NCT07003295

/ RecruitingPhase 2IIT

A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy

This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.

Start Date14 Aug 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Obinutuzumab

100 Translational Medicine associated with Obinutuzumab

100 Patents (Medical) associated with Obinutuzumab

1,208

Literatures (Medical) associated with Obinutuzumab

31 Dec 2026·mAbs

Impact of afucosylation strategy on antibody function: a comparative study of glycoengineered anti-CD20 antibodies Obinutuzumab and Obinutuzumab beta

Article

Author: Sun, Mingze ; Huang, Shuo ; Shuang, Qing ; Sun, Jicui ; Jiang, Lingling ; Li, Feng ; Shen, Qunfang ; Yang, Lijing ; Zhang, Lunfeng ; Li, Jiangmei ; Chen, Hong ; Lin, Guangzhong

Enhancing antibody-dependent cellular cytotoxicity (ADCC) via N-glycan afucosylation of Asn-297 is a validated strategy to improve the clinical efficacy of therapeutic antibodies. However, the impact of distinct glycoengineering approaches on the function of antibodies has not been systematically elucidated. Here, we experimentally compared two type II anti-CD20 antibodies, Obinutuzumab (Gazyva®) and Obinutuzumab beta (MIL62, Bejescin®), which share identical amino acid sequences but exhibit divergent glycosylation profiles. MIL62 was engineered with complete core afucosylation (fucose < 0.1%) lacking bisecting N-acetylglucosamine (GlcNAc) via knockout of the GDP-fucose transporter (GFT) in Chinese hamster ovary (CHO) cells used to produce the antibody. Conversely, Gazyva was produced in CHO cells that overexpress β-1,4-N-acetylglucosaminyltransferase III (GnT-III) and α-mannosidase II (α-ManII), resulting in ~50% fucose content and >80% bisecting GlcNAc occupancy. These distinct glycoengineering strategies led to disparate functional outcomes: afucosylated MIL62 showed improved FcγRIIIA binding and ADCC potency, while Gazyva with bisecting GlcNAc modifications exhibited higher glycoform heterogeneity and reduced thermal stability. Both antibodies displayed comparable FcRn binding, mannosylation, sialylation, and murine pharmacodynamics, mediating complete depletion of B cells in blood, lymph nodes, and spleen. Upon antigen rechallenge, MIL62 suppressed specific antibody titers, indicating memory B-cell eradication and profound potential to prevent autoimmune relapse. This study demonstrates that distinct glycoengineering strategies fundamentally reshape the antibody glycan profile beyond merely reducing fucose. These structural differences not only fine-tune ADCC potency, but also impact antibody stability. Particularly, complete afucosylation of MIL62 led to optimized ADCC potency and effectively suppressed pathogenic B cells repopulation in a delta-like ligand 3 (DLL3) re-challenge model, providing a critical framework for designing next-generation antibodies with superior therapeutic efficacy.

18 Jun 2026·BLOOD

Venetoclax combinations in untreated CLL: 5-year results and patient-reported outcomes analysis of the CLL13/GAIA trial

Article

Author: Frederiksen, Henrik ; Knauf, Wolfgang ; Tausch, Eugen ; Nösslinger, Thomas ; Fürstenau, Moritz ; Ritgen, Matthias ; Kroeber, Alexander ; Widmer, Anouk ; Janssens, Ann ; Snijders, Tjeerd F. ; Fischer, Kirsten ; Kreuzer, Karl-Anton ; O’Shea, Derville ; Rotbain, Emelie C. ; Fink, Anna ; Kater, Arnon P. ; Siemes, Claire ; Juliusson, Gunnar ; Levin, Mark-David ; von Tresckow, Julia ; Brüggemann, Monika ; Baumann, Michael ; Stilgenbauer, Stephan ; Velders, Gerjo ; Lindström, Vesa ; da Cunha-Bang, Caspar ; Robrecht, Sandra ; Giza, Adam ; Enggaard, Lisbeth ; Thornton, Patrick ; Illmer, Thomas ; Zhang, Can ; Vekemans, Marie-Christiane ; Holmes, Emily ; Ranti, Juha ; Hallek, Michael ; Staber, Philipp B. ; Lotfi, Kourosh ; Eurelings, Laura ; Wendtner, Clemens-Martin ; Tadmor, Tamar ; D’Brot, Ronald ; Simon, Florian ; Schöttker, Björn ; Herishanu, Yair ; Schneider, Christof ; Poulsen, Christian B. ; Eichhorst, Barbara ; Zahn, Mark-Oliver ; Niemann, Carsten U. ; de Heer, Koen ; Gregor, Michael

Abstract:

Fixed-duration venetoclax combinations have become a standard first-line treatment in chronic lymphocytic leukemia (CLL). The phase 3 CLL13/GAIA trial assesses 3 time-limited combinations: venetoclax-rituximab (RV), venetoclax-obinutuzumab (GV), and venetoclax-obinutuzumab-ibrutinib (GIV), in comparison with chemoimmunotherapy (CIT). Fit patients with CLL without TP53 aberrations were randomized between 6 cycles of CIT (fludarabine-cyclophosphamide-rituximab [FCR] or bendamustine-rituximab [BR]) or 12 cycles of RV, GV, or GIV (GIV: ibrutinib continuation until cycle 36 if measurable residual disease at months 12/15). In total, 926 patients were randomized (GIV: 231, GV: 229, RV: 237, and CIT: 229 [FCR: 150, BR: 79]). With a median observation time of 63.8 months, 5-year progression-free survival (PFS) rates were 81.3% (GIV), 69.8% (GV), 57.4% (RV), and 50.7% (CIT). PFS was superior for GV and GIV compared with CIT and RV (P< .001 in each case). In addition, GIV showed longer PFS than GV (P = .0046). Venetoclax-based re-treatment after venetoclax-based first-line regimens was efficacious, with 2-year treatment-free survival >80% from second-line treatment. No differences in overall survival were observed between treatment arms (5-year rates: GIV, 94.3%; GV, 93.6%; RV, 94.7%; and CIT, 90.7%). The incidence rates of severe infections were highest with CIT, whereas cardiac events were most frequent with GIV. Compared with patients treated with CIT, those treated with GV or RV reported rapid and significantly greater quality-of-life (QoL) improvements. In the GIV arm, clinically relevant QoL improvements occurred later (month 15, after the end of treatment in most patients) than with GV/RV, likely due to a higher treatment-related symptom burden. This trial was registered at www.clinicaltrials.gov as NCT02950051.

11 Jun 2026·BLOOD

Fixed-duration VenO vs FCR/BR in fit patients with untreated CLL: primary analysis of the phase 3 CRISTALLO trial

Article

Author: Morschhauser, Franck ; Sportoletti, Paolo ; Laurenti, Luca ; Huang, Weize ; Casado Montero, Luis Felipe ; Ibatici, Adalberto ; Jiang, Yanwen ; Cazares, Oscar ; Boyer, Michelle ; Mulligan, Stephen P. ; Opat, Stephen ; Jin, Hyun Yong ; Thadani-Mulero, Maria ; Sharman, Jeff P. ; Harrup, Rosemary ; Clark, Emma ; Ferrant, Emmanuelle ; Marasca, Roberto

Abstract:

The phase 3 CRISTALLO trial compared first-line fixed-duration venetoclax-obinutuzumab (VenO) vs fludarabine, cyclophosphamide, and rituximab (FCR)/bendamustine-rituximab (BR) in patients with chronic lymphocytic leukemia (CLL), using undetectable minimal residual disease (uMRD) as the sole primary end point. Previously untreated patients with a cumulative illness rating scale score ≤6 and creatinine clearance ≥70 mL/min without del(17p)/TP53 mutations were randomized 1:1 to VenO or FCR/BR. The primary end point was uMRD (<10−4) in peripheral blood (PB) using next-generation sequencing at month 15. Key secondary end points included uMRD (<10−4) in PB and bone marrow (BM) at end of treatment (EOT) and progression-free survival (PFS). uMRD at deeper cutoffs were explored. At data cutoff (19 March 2024), 80 patients received VenO, and 86 received FCR/BR. Baseline characteristics were generally balanced across arms. The primary end point was met: 81.3% (VenO) and 54.7% (FCR/BR) achieved uMRD (<10−4) in PB at month 15 (P = .0004). uMRD (<10−4) in PB and BM at EOT was also higher with VenO vs FCR/BR. Short follow-up precluded evaluation of PFS at the first planned interim analysis; however, fewer patients progressed/died with VenO vs FCR/BR (7 vs 13). At month 15, 65.0% (VenO) and 25.6% (FCR/BR) achieved uMRD (<10−6) in PB. The overall safety profile was consistent with the known safety profile of each drug. No patient in the VenO arm was deemed high risk for tumor lysis syndrome (TLS) after obinutuzumab debulking; no clinical TLS occurred. These results confirm and extend the findings from the GAIA-CLL13 trial, validating increased depth of response with VenO vs chemoimmunotherapies. This trial was registered at www.clinicaltrials.gov as NCT04285567.

364

News (Medical) associated with Obinutuzumab

18 Jun 2026

·www.biospace.com

FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma

Filing acceptance based on data from the phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death 1 People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment Basel, June 18, 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy® (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy. The FDA is expected to make a decision on approval by 9 February 2027. The sBLA acceptance is based on results from the phase III SUNMO study. At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination demonstrated a 59% reduction in risk of disease progression or death (progression-free survival [PFS]) compared to MabThera®/Rituxan® (rituximab), gemcitabine and oxaliplatin (R-GemOx) (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001) and a three-times longer median PFS at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1). 1 The safety pro the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines. 1 The incidence of cytokine release syndrome events (CRS) in the Lunsumio VELO plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events. 1 Updated data were presented recently at the American Society of Clinical Oncology Annual Meeting and the European Hematology Association Congress, which showed that with longer follow-up, this treatment combination continued to demonstrate clinical benefit in PFS, particularly in the second-line setting, with no new safety signals. 2,3 “Relapsed or refractory large B-cell lymphoma is an aggressive disease thereby representing one of the highest unmet needs in lymphoma care,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “If approved, this Lunsumio/Polivy combination could provide an important chemotherapy-free, outpatient-ready option to help improve outcomes in this setting.” "When treating large B-cell lymphoma, the second-line setting represents a critical window where we must act quickly with effective therapies," said Tara M. Graff, DO, MS, Director of Clinical Research at Mission Cancer and Blood. "Current advanced therapies may present complex logistical and geographical barriers for many patients. Since most patients in the US are treated in the community setting, we need more chemotherapy-free, outpatient-ready treatments, like Lunsumio and Polivy." LBCL, composed predominantly of DLBCL, is the most common type of non-Hodgkin lymphoma with more than 18,000 new diagnoses each year in the US. 4 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. 5,6 Because this stage of disease is time-sensitive, delays caused by referral requirements, inpatient coordination, or complex treatment logistics can have meaningful clinical consequences. 7,8 "Navigating relapsed or refractory large B-cell lymphoma can be challenging, particularly for patients who do not live near a major academic centre,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. "The potential new Lunsumio VELO and Polivy combination may address this critical access issue by offering treatment options closer to where a patient lives. It fills a gap in care for people who can't afford to travel far distances or for long periods of time for treatment." Lunsumio is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. It is designed with the unique needs and preferences of patients in mind, offering the possibility of outpatient treatment and flexibility between intravenous (IV) and subcutaneous administration routes. Lunsumio IV and Lunsumio VELO are approved for people with third-line or later follicular lymphoma (FL). Lunsumio holds the most extensive long-term data for any bispecific antibody in lymphoma. Ongoing development of Lunsumio in combination with other treatments includes the phase III CELESTIMO and MorningLyte studies in second-line or later and frontline FL, respectively. About the SUNMO study The SUNMO study [ NCT05171647 ] is a phase III, randomised, open-label, multicentre trial evaluating the efficacy and safety of Lunsumio VELO™ (mosunetuzumab) in combination with intravenously administered Polivy® (polatuzumab vedotin) versus MabThera®/Rituxan® (rituximab) plus gemcitabine and oxaliplatin in patients with relapsed or refractory large B-cell lymphoma who have received at least one prior systemic therapy and are ineligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes. About Large B-cell Lymphoma (LBCL) Large B-cell lymphomas, composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cell. 5 DLBCL is a highly aggressive and life-threatening disease. 9 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. 5,6 While existing intensive standard-of-care treatments exist, structural, geographical, and clinical access barriers mean that many patients — particularly those in rural communities or receiving care outside of specialised academic transplant centres — face significant burdens and inequities in obtaining timely treatment. 10,11 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. About Lunsumio® (mosunetuzumab) Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate malignant B cells. Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory follicular lymphoma (FL) in both intravenous and subcutaneous (Lunsumio VELO™) formulations. A robust, global development programme is ongoing to explore the clinical utility of Lunsumio earlier in the disease course and in novel combinations, including the phase III CELESTIMO trial in second-line or later FL. About Polivy® (polatuzumab vedotin) Polivy is a first-in-class antibody-drug conjugate (ADC) targeted against CD79b, a protein preferentially expressed on the surface of mature B cells. Polivy binds to CD79b on the lymphoma cells and delivers a cytotoxic chemotherapy agent directly into the cell, inducing cell death via apoptosis while minimising damage to healthy tissue. Polivy is widely approved globally in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone for previously untreated (first-line) diffuse large B-cell lymphoma (DLBCL), as well as in combination with bendamustine and MabThera/Rituxan for relapsed or refractory DLBCL. About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and off-the-shelf allogeneic CAR T-cell therapies. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Westin J, et al. Mosunetuzumab plus polatuzumab vedotin is superior to R-GemOx in transplant-ineligible patients with R/R LBCL: primary results of the Phase III SUNMO trial. Presented at: ICML; 2025 17-21 June; Lugano, Switzerland, Abstract #LBA3. [2] Kim W, et al. Mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): Updated efficacy and safety from the phase 3 SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups. Presented at: ASCO Annual Meeting; 2026 May 29-Jun 2; Chicago, IL, USA, Abstract #7007. [3] Budde E, et al. Mosunetuzumab plus polatuzumab vedotin versus rituximab, gemcitabine and oxaliplatin in large B-cell lymphoma: updated efficacy and safety from the phase 3 SUNMO study including in patient subgroups. Presented at: EHA Congress; 2026 Jun 11-14; Stockholm, Sweden, Abstract #PF968. [4] Lymphoma Research Foundation. Understanding Diffuse Large B-Cell Lymphoma [Internet; cited June 2026]. Available from: . [5] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. [6] Maurer MJ, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32:1066-73. [7] Morimoto S, Jo T, Kitawaki T, et al. Prolonged chimeric antigen receptor-T apheresis to infusion time is associated with inferior outcomes in diffuse large B-cell lymphoma. Br J Haematol. 2025;207(4):1484–1494. [8] Battiwalla M, et al. Access barriers to anti-CD19+ CART therapy for NHL across a community transplant and cellular therapy network. Blood Advances. 2025;9(2):429-435. [9] Adiyaman SC, et al. Prognostic Factors in Elderly Patients with Diffuse Large B-Cell Lymphoma and Their Treatment Results. Turk J Haematol. 2019;36(2):81–87. [10] Patel AR, et al. Access to Chimeric Antigen Receptor T-Cell Therapy in Patients With Diffuse Large B-Cell Lymphoma. JAMA Netw Open. 2025 Oct 22;8(10):e2538602. [11] Luminari S, et al. Overcoming barriers to referral for CAR T-cell therapy in patients with non-Hodgkin aggressive B-cell lymphomas: A Delphi consensus. Cytotherapy. 2025;27(11):1316-1325. Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Irène Stephan Phone: +41 79 377 83 75 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment Roche Media Investor Release SUNMO FDA filing acceptance media release English

Phase 3Clinical ResultDrug ApprovalImmunotherapyCell Therapy

16 Jun 2026

·www.prnewswire.com

AbbVie Presents New Data at EHA 2026 Congress for VENCLEXTA®/VENCLYXTO® (venetoclax) in First-Line Chronic Lymphocytic Leukemia Highlighting Long-Term Treatment Outcomes for Patients: Nine-Year Results

June 12, 2026 -- AbbVie (NYSE: ABBV) today announced new Phase 3 data on a fixed-duration venetoclax-based combination at the European Hematology Association (EHA) 2026 Congress taking place June 11-14 in Stockholm, Sweden. Final results from the Phase 3 CLL14 trial in previously untreated chronic lymphocytic leukemia (CLL), which was conducted in collaboration with the German CLL Study Group, will be featured in an oral presentation. "The nine-year results from the landmark Phase 3 CLL14 trial affirm venetoclax's enduring safety and efficacy," said Daejin Abidoye, vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These data continue to add to the impressive body of evidence supporting the first-line use of venetoclax-based combination regimens in broader CLL patient populations, offering patients unprecedented time to next treatment — and therefore time off treatment — after one year of fixed-duration therapy. This research advances our mission to transform care and deliver better outcomes for patients living with difficult-to-cure blood cancers." "Venetoclax in combination with obinutuzumab has shown positive responses across several key measures compared to obinutuzumab plus chlorambucil, including an extended increase in progression-free survival in previously untreated patients with chronic lymphocytic leukemia," said Kirsten Fischer, M.D., investigator in the CLL14 study, University Hospital Cologne. "Importantly, with a demonstrated median time to next treatment of approximately eight years, the findings reflect the sustained durability of this combination treatment option with a meaningful time without CLL specific treatment for patients." A final analysis of the Phase 3 CLL14 trial, conducted in close collaboration with the German CLL Study Group, comparing venetoclax plus obinutuzumab to chlorambucil plus obinutuzumab in previously untreated patients with CLL and coexisting medical conditions, found that venetoclax plus obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, providing a limited-duration treatment option for unfit patients with previously untreated CLL. The nine-year analysis demonstrated the long-term off-treatment efficacy and safety of the venetoclax plus obinutuzumab fixed-duration combination, with the median time to next treatment (TTNT) of 7.6 years.1 After a median follow-up of 9.2 years, treatment with venetoclax plus obinutuzumab resulted in superior PFS compared to the obinutuzumab plus chlorambucil group, with median PFS of 6.4 years versus 3.2 years, respectively (HR 0.50 [95% CI 0.39-0.63], p1,2 CLL is one of the most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes).3 Patients with CLL often experience relapsed disease, meaning the cancer has returned after previously responding to treatment, while others experience refractory disease when the cancer stops responding to therapy.4 While outcomes have improved in recent years, patients can often face long treatment durations and ongoing disease management challenges. The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial (NCT02242942), which was conducted in close collaboration with the German CLL Study Group (GCLLSG), evaluated the efficacy and safety of a combined regimen of venetoclax and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously untreated patients with CLL and co-existing medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance 1,2 VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis. VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S. Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib with or without obinutuzumab in combination with obinutuzumab in combination with ibrutinib VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. VENCLYXTO monotherapy is indicated for the treatment of CLL: In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalImmunotherapy

15 Jun 2026

·www.biospace.com

2026 EHA | Over 40 Orelabrutinib Studies Presented, Including First Clinical Data from Europe and US TN CLL/SLL Patients

BEIJING, June 15, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that over 40 clinical studies of the Company's novel BTK inhibitor orelabrutinib were presented at the European Hematology Association (EHA) 2026 Congress. Clinical data on the efficacy and safety of orelabrutinib in treatment-naïve (TN) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients from the United States and Europe was released for the first time. A series of clinical studies on orelabrutinib covered multiple hematological malignancies, including CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and primary central nervous system lymphoma (PCNSL). These findings further support the excellent efficacy and safety of orelabrutinib. Poster Presentation: 1. Orelabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Safety and Efficacy Results from a Global Phase 1/2 Study. (No. PF610) This study is to evaluate the safety and efficacy of orelabrutinib in patients with CLL/SLL from the United States and Europe. The researchers include multiple world-renowned oncology centers such as Mayo Clinic. Results are consistent with the prior report in Chinese patients, confirming the efficacy and safety of orelabrutinib for CLL/SLL in a global population. In evaluable TN CLL/SLL patients (median follow-up 38.1 months), ORR was 100%, with 36-month PFS rate at 94.4% and 36-month OS rate at 100% respectively. In evaluable R/R CLL/SLL patients (median follow-up 36.8 months), ORR was 86.7%, with 36-month PFS rate 77.9% and the 36-month OS rate 80.1% respectively. Orelabrutinib demonstrates high kinase selectivity, alleviates off-target inhibition, and reduces cardiovascular, bleeding, and hematologic adverse events. 2. Long-term Follow-up of Orelabrutinib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (No. PF949) With long-term follow-up, orelabrutinib demonstrated rapid and durable responses, indicating sustained therapeutic benefit in patients with r/r MZL. Importantly, no new safety signals were observed during extended follow-up. At a median follow-up of 36.8 months, the investigator-assessed ORR was 58.9%, median PFS was 44.4 months, and the 36-month OS rate was 84.7%. 3. Risk-Adapted Management with Obinutuzumab and Orelabrutinib with or without Lenalidomide in Untreated Marginal Zone Lymphoma: First Report of a Prospective, Phase II, Multi-Centre (MAGIC) Study (No. PS2037) This is a prospective, phase II, multicenter study. The preliminary results demonstrated encouraging efficacy and a manageable safety pro patients with previously untreated MZL. Patients with an MZL-IPI score of 0–2 received obinutuzumab plus orelabrutinib (O 2 regimen). Those with a score of 3–5 received obinutuzumab, orelabrutinib and lenalidomide (RO 2 regimen). In patients who completed six cycles of induction therapy, the CRR was 85.7% and ORR was 95.3% in the O 2 group, and the CRR was 71.4% and ORR was 85.7% in the RO 2 group. The study is ongoing, and updated efficacy and safety data will be reported in due course. 4. Polatuzumab Vedotin Combined with Orelabrutinib and Rituximab (PRO Regimen) as Frontline Therapy in Very Elderly and Frail Patients with DLBCL: Updated Results from a Phase II Study (No. PS2072) Results support the PRO regimen, which includes orelabrutinib, as a feasible strategy for vulnerable patients. Patients had a median age of 78 years. At the completion of combination therapy, the CR rate was 91.7%. With a median follow-up of 7.0 months, neither the median PFS nor the median OS has been reached. The estimated 9-month PFS rate was 92.8%. Most other hematologic and non-hematologic toxicities were confined to Grade 1-2 and were clinically manageable with supportive care. 5. The Real-World Efficacy of Bruton’s Tyrosine Kinase Inhibitors Plus High-Dose Methotrexate-Based Induction Treatment for Untreated Primary CNS Lymphoma: A Single-Center Retrospective Analysis (No. PF1035) This analysis aims to evaluate the efficacy of BTKi like orelabrutinib plus HD-MTX-based chemotherapy regimens as induction treatment for newly diagnosed PCNSL patients in a real-world cohort. The results show that the ORR after induction treatment was 88.6% and the CR rate was 81.1%. There was no significant difference in PFS among the three BTKi, but a significant improvement in OS was observed in the orelabrutinib group (HR 0.26, P = 0.016). These results support the use of BTKi-containing treatment regimens as a first-line therapy for PCNSL in clinical practice. More studies on orelabrutinib have been accepted for poster presentations at the 2026 EHA Congress. Details are listed below: Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab Followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (No. PF959) Efficacy, Safety, and Genetic Analysis of Orelabrutinib Combined with Rituximab as First-Line Systemic Treatment for Marginal Zone Lymphoma (No. PF951) Preliminary Analysis of Orelabrutinib Combined with Obinutuzumab for Marginal Zone Lymphoma (ORION Study) (No. PS2050) Preliminary Results of Orelabrutinib Followed by Response-Adapted Ultra-Low-Dose 4Gy Radiotherapy as First-Line Treatment for Localized MALT Lymphoma: A Prospective, Open-Label, Phase II Study (No. PS2053) Integrative Transcriptomic Profiling Reveals the Molecular Landscape and Regulatory Drivers of Blastoid Mantle Cell Lymphoma (No. PS1099) Bruton Tyrosine Kinase Inhibitor Maintenance Therapy in First-Line Diffuse Large B-Cell Lymphoma: A Multicenter Real-World Study Challenging Conventional Paradigms (No. PS2127) Orelabrutinib Plus R-CHOP for the Treatment of Newly Diagnosed Non-GCB Double-Expressor Diffuse Large B-Cell Lymphoma: A Multicenter, Single-Arm, Phase II Study (No. PS2075) Large-Scale Real-World Clinical Characteristics and Efficacy of Diffuse Large B-Cell Lymphoma Across Distinct Molecular Subtypes: Interim Data from the BELIEVE Study (No. PF991) Clinical Characteristics and Efficacy of MYC/BCL-2 Double-Expressing Diffuse Large B-Cell Lymphoma: Real-World Data from the BELIEVE Study (No. PS2103) Orelabrutinib, Rituximab, and Thiotepa (ORT) With or Without High-Dose Methotrexate for Untreated Primary Central Nervous System Lymphoma (No. PS2088) Efficacy and Safety of Orelabrutinib Combined with Sintilimab in Patients with Relapsed/Refractory Primary Central Nervous System Lymphoma (R/R PCNSL): A Prospective Multicenter Phase II Study (No. PS2130) Orelabrutinib in Patients with Relapsed or Refractory Primary or Secondary Central Nervous System Lymphoma: A Multicenter, Open-Label, Phase II Study (No. PS2090) Additionally, more than 20 studies on orelabrutinib were selected for online presentation. The 2026 EHA Congress is one of the most influential academic conferences in hematology and was held in Stockholm, Sweden. About InnoCare Pharma InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit and follow us on LinkedIn. Media Investors Chunhua Lu 86-10-66609879 86-10-66609999 chunhua.lu@innocarepharma.com ir@innocarepharma.com

100 Deals associated with Obinutuzumab

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KEGG	Wiki	ATC	Drug Bank
D09321	Obinutuzumab	L01XC15	DB08935

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lupus Nephritis	United States	Genentech, Inc.	17 Oct 2025
CD20 Positive B-Cell Chronic Lymphocytic Leukemia	Japan	Chugai Pharmaceutical Co., Ltd.	23 Dec 2022
CD20 positive Follicular Lymphoma	Japan	Nippon Shinyaku Co., Ltd.	02 Jul 2018
CD20 positive Follicular Lymphoma	Japan	Chugai Pharmaceutical Co., Ltd.	02 Jul 2018
Follicular Lymphoma	Australia	F. Hoffmann-La Roche Ltd.	15 May 2014
Chronic Lymphocytic Leukemia	United States	Genentech, Inc.	01 Nov 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Membranous Glomerulonephritis	NDA/BLA	China	Roche Pharma (Schweiz) AG	04 Jun 2026
Idiopathic Membranous Glomerulonephritis	NDA/BLA	China	Roche Holding (UK) Ltd.	04 Jun 2026
Idiopathic Membranous Glomerulonephritis	NDA/BLA	China	Roche Diagnostics GmbH	04 Jun 2026
Nephrosis, Congenital	NDA/BLA	Japan	Chugai Pharmaceutical Co., Ltd.	14 May 2026
Nephrotic Syndrome	NDA/BLA	China	Roche China Holding Ltd.	23 Apr 2026
Nephrotic Syndrome	NDA/BLA	China	Roche Pharma (Schweiz) AG	23 Apr 2026
Systemic Lupus Erythematosus	NDA/BLA	United States	Roche Holding AG	21 Apr 2026
Marginal Zone B-Cell Lymphoma	NDA/BLA	China	F. Hoffmann-La Roche Ltd.	28 Sep 2019
Glomerulonephritis, Membranous	Phase 3	Netherlands	-	01 Oct 2025
Tumor Lysis Syndrome	Phase 3	United States	AbbVie, Inc.	05 Aug 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2026	Not Applicable	Scleroderma, Systemic	5	Obinutuzumab	zgqsxhaoax(zctsfomzig) = No infusion reaction was observed. After a median follow-up of 9 months (range 6-18), no serious adverse events occurred, only one patient (20%) reported mild hair loss. aufrxopbxr (fyswcepbut )	Positive	11 Jun 2026
NCT04221477 (REGENCY, EULAR2026)	Phase 3	Lupus Nephritis	64	Obinutuzumab + Standard Therapy	ozqjliarej(budnsmbpzt) = qqxcstwyfk fqssiugxnv (izqcmgwzbu )	Positive	11 Jun 2026
				Placebo + Standard Therapy	ozqjliarej(budnsmbpzt) = wukbjnzzqm fqssiugxnv (izqcmgwzbu )
EULAR2026	Not Applicable	Lupus Nephritis	11	Obinutuzumab	ofxwivdwkb(pdpvxrpudq) = ssvlxlufwl lpvicqimdl (edwjzbspqv ) View more	Positive	11 Jun 2026
NCT04285567 (CRISTALLO, Pubmed \| Blood)	Phase 3	Chronic Lymphocytic Leukemia First line	166	Venetoclax-obinutuzumab (VenO)	fcyttzhack(evnylewdbo) = egxdjpajnz nxrxlukprt (plssuvohzw ) View more	Positive	11 Jun 2026
				Fludarabine, cyclophosphamide, and rituximab (FCR) or bendamustine-rituximab (BR)	fcyttzhack(evnylewdbo) = frlekdocya nxrxlukprt (plssuvohzw ) View more
ASCO2026	Not Applicable	Follicular Lymphoma	1,482	Obinutuzumab + chemotherapy	ifddgustpf(xppdtjrjzn): OR = 1.56 (95.0% CI, 1.04 - 2.33), P-Value = 0.03 View more	Positive	29 May 2026
				Rituximab + chemotherapy
NCT05169658 (RESPONSE-ADAPTED TREATMENT WITH MOSUNETUZUMAB, CTgov)	Phase 2	Follicular Lymphoma \| Indolent B-Cell Non-Hodgkin Lymphoma \| Marginal Zone B-Cell Lymphoma	42	FDG-Positron Emission Tomography+Mosunetuzumab+Polatuzumab Vedotin+Obinutuzumab	gejhgdiylk = qxzgrpcalc gnqysjjfip (eogblgoovi, ozmsuixgmo - grfdtvlxpr) View more	-	13 May 2026
NCT04855695 (AACR2026)	Phase 1/2	Mantle-Cell Lymphoma	9	ObinutuzumabAcalabrutinibVenetoclaxnib + ObinutuzumabAcalabrutinibVenetoclax + ObinutuzumabAcalabrutinibVenetoclaxab	qcizbnmjod(qxxmkxbodo) = pudkrodmdz zktnefisev (uffhgydxzm )	Positive	20 Apr 2026
				Obinutuzumab (Durable Response)	qcizbnmjod(qxxmkxbodo) = kapcxasbhz zktnefisev (uffhgydxzm )
NCT04963296 (ALLEGORY, Pubmed \| N Engl J Med \| Company_Website) Manual	Phase 3	Systemic Lupus Erythematosus	303	Obinutuzumab	qkhettyzno(eqxndvymou) = qenhoslbrx qcayekdttu (szsmvnfxxx ) View more	Positive	06 Mar 2026
				Placebo	qkhettyzno(eqxndvymou) = tmpeqfidjb qcayekdttu (szsmvnfxxx ) View more
ASH2025	Not Applicable	Mantle-Cell Lymphoma	15	ObinutuzumabPomalidomideZanubrutinibVenetoclaxab + ObinutuzumabPomalidomideZanubrutinibVenetoclaxib + ObinutuzumabPomalidomideZanubrutinibVenetoclaxde + ObinutuzumabPomalidomideZanubrutinibVenetoclax	wayevrrqbq(djimiliyzg) = neutropenia (in 9 [60.0%] of 15 patients), thrombocytopenia(in 3 [20.0%] of 15 patients), infections (in 2 [13.3%] patients) lhiuhucasc (fsmgvauybt )	Positive	06 Dec 2025
ASH2025	Phase 2	Follicular Lymphoma First line	40	Obinutuzumab+Ibrutinib+Venetoclax	ynbnfvxwcu(bgclzzyxmr) = fsygpblgdx pzxxgpukfn (ipibbgbzcn ) View more	Positive	06 Dec 2025

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