Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku - LARVOL DELTA

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL) (clinicaltrials.gov) - P3 | N=630 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Chemotherapy-free combination of ibrutinib and obinutuzumab for untreated advanced follicular lymphoma: results of a phase II study from the German Lymphoma Alliance. (PubMed, Haematologica) - "The trial failed the primary efficacy endpoint of the chemotherapyfree regimen of obinutuzumab and ibrutinib in follicular lymphoma patients. However, the combination achieved durable and deep responses and revealed an acceptable safety profile."

Journal • P2 data • B Cell Lymphoma • Cardiovascular • Fatigue • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hypertension • Indolent Lymphoma • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases • Thrombocytopenia

AB-101-03: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Trial completion date: Oct 2026 ➔ Aug 2027 | Trial primary completion date: Oct 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG) (clinicaltrials.gov) - P2 | N=66 | Completed | Sponsor: German CLL Study Group | Active, not recruiting ➔ Completed

Trial completion • Chronic Lymphocytic Leukemia

CLL2-BZAG: Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: German CLL Study Group | Trial primary completion date: Feb 2025 ➔ Dec 2026

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2 • PLCG2

Effectiveness and Remission Predictors of Obinutuzumab in Primary Membranous Nephropathy (ERA 2025) - "Background and Aims:Obinutuzumab is a more humanized and more potent efficacy in basic research, and it has a different epitope anti-CD20 monoclonal antibody compared with rituximab. Obinutuzumab showed a rapid and long-acting effect in reducing the serum anti- PLA2R antibody levels in PMN patients, and finally led to good clinical remission. The decrease rate of the anti-PLA2R antibody one month after administration has a predictive value for the clinical remission of PMN."

Clinical • Glomerulonephritis • Renal Disease

EFFECTS OF OBINUTUZUMAB ON URINARY RENAL BIOMARKERS IN LUPUS NEPHRITIS: A POST HOC EXPLORATORY ANALYSIS OF THE PHASE II NOBILITY STUDY (ERA 2025) - P2, P3 | " Patients with active LN received standard therapy (mycophenolate mofetil and glucocorticoids) plus OBI 1000 mg or standard therapy plus placebo (PBO) on Weeks 0, 2, 24 and 26. Exploratory analyses from the Phase II NOBILITY study showed that OBI may induce early beneficial effects on kidney inflammation and damage markers in LN, as evidenced by reduced urine CCL2, KIM1 and sCD163 and increased urine EGF. Importantly, these urinary changes occurred within 24 weeks of OBI initiation (later for sCD163), preceding improvements in UPCR observed at Week 52.1 These findings suggest (i) a mechanistic hypothesis whereby OBI modulates the kidney inflammatory microenvironment to promote repair and protect the parenchyma and long term function, reinforcing its potential as a promising therapy for patients with LN; and (ii) urine biomarkers may offer early insights into treatment responses and warrant further investigation in larger studies for potential use in therapeutic..."

Biomarker • P2 data • Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • CCL2 • CD163 • EGF • KIM1

INShore: Phase III, Multicentre, Randomised, Open-Label Study of Efficacy and Safety of Obinutuzumab vs MMF in Patients With Childhood-Onset Idiopathic Nephrotic Syndrome (ERA 2025) - P3 | "Over the past decade, the effectiveness of B-cell–depleting monoclonal antibodies, primarily rituximab, for treating FRNS/SDNS has established the pathogenic role of B cells in this condition...The INShore study (NCT05627557, EU CT 2023-505140-19-00) assesses the efficacy and safety of obinutuzumab versus mycophenolate mofetil (MMF) among children and young adults (aged ≥2-25 years) with childhood-onset FRNS or SDNS... The successful enrolment and diverse demographics of the INShore study participants provide a robust basis for assessing the efficacy and safety of obinutuzumab versus MMF in managing childhood-onset idiopathic nephrotic syndrome. Full results of the INShore study will be available following the primary analysis, once all participants have completed 52 weeks in the study."

Clinical • P3 data • Glomerulonephritis • Nephrology • Renal Disease

Obinutuzumab alone may be an effective option for the initial therapy of adult minimal change disease (ERA 2025) - "Background and Aims:Anti-CD20 monoclonal antibody (such as rituximab) has proven effective and safe in pediatric and adult minimal change disease (MCD) in recent studies. In this study, we compared the effectiveness of obinutuzumab versus GC as an initial treatment for adult MCD patients. The results of this study showed that the induction regimen of obinituzumab alone can achieve clinical remission in MCD patients, especially those with previous steroids resistant/dependent, longer duration of MCD, elderly, high levels of BMI and HbA1c, avoid the side effects of steroids, and reduce the relapse in MCD patients. This retrospective study is the first study demonstrated that obinituzumab alone as the initial therapy can effectively induce and maintain remission and can be applied as an alternative to GC therapy in adult MCD patients."

Clinical • Cardiovascular • Cytomegalovirus Infection • Diabetes • Glomerulonephritis • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Oncology • Pediatrics

Anti-drug antibodies are common in Membranous Nephropathy and affect response to rituximab: a multicenter study (ERA 2025) - "In accordance with literature data, our study confirmed that: (1) up to 50% of patients with pMN treated with rituximab develop ADA; (2) ADA are associated with a higher relapse rate in patients with pMN. Furthermore, for the first time we demonstrated that (3) ADA are significantly associated with a reduced remission rate in patients with pMN, making these antibodies one of the most important prognostic factors; (4) standardized monitoring of ADA at both 9th- and 12th-month following rituximab infusion, in addition to the monitoring of ADA prior to rituximab re-administration, would allow the identification of about 90% of ADA positive patients. In this subgroup of patients, alternative therapies with obinutuzumab or ofatumumab should be considered."

Clinical • Glomerulonephritis • Immunology • Renal Disease

Real-life experience with the second-generation anti-CD20 antibodies for treatment of immune-mediated glomerular diseases (ERA 2025) - "The indications for the new anti-CD20 therapy were: 4 (66%) for refractory disease, 1 (16.7%) for recurrent flares, and 1 (16.7%) due to an anaphylactic reaction to rituximab. The new anti-CD20 therapies used were: obinutuzumab in 4 (66%) patients and ofatumumab in 2 (33%)... The use of new anti-CD20 therapies for the treatment of immune-mediated glomerular diseases appears to be more effective than Rtx in inducing remission of glomerulopathy in refractory cases. New anti-CD120 achieved CD19 depletion in all cases and with an adequate safety profile. Further research and clinical trials should be conducted to confirm these positive results."

Clinical • Chronic Kidney Disease • Complement-mediated Rare Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Lupus Nephritis • Nephrology • Renal Disease

Obinutuzumab in Steroid-Resistant Podocytopathies (ERA 2025) - "Conventional treatments, including rituximab and steroid-sparing agents such as mycophenolate mofetil (MMF) and calcineurin inhibitors, often yield limited success. We present six patients with recurrent steroid-resistant nephrotic syndrome (SRNS) refractory to standard treatment, who achieved complete and/or sustained remission following obinutuzumab administration. The therapy resulted in sustained proteinuria reduction and serum albumin normalization, allowing for successful transition to MMF monotherapy. Compared to rituximab, obinutuzumab may offer a more potent and prolonged B-cell depletion, translating into improved clinical outcomes in refractory SRNS."

Glomerulonephritis • Nephrology • Renal Disease

Obinutuzumab in rituximab-intolerant ANCA-associated vasculitis patients (ERA 2025) - "Background and Aims:In anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) the fundament for both induction and maintenance treatment is anti-CD20 therapy with rituximab.1 However, some patients experience serious infusion or allergic reactions, rendering them intolerant for rituximab retreatments and forcing them to rely on less effective alternatives such as azathioprine.1 A logical alternative for rituximab is obinutuzumab of which equivalent or even superior effectiveness can be expected. We can conclude that in rituximab-intolerant AAV patients obinutuzumab led to prolonged B-cell depletion and more frequent ANCA-seroconversion, both associated with reduced risk of relapse in AAV.1 Importantly, immunological effects of obinutuzumab were also superior to rituximab in AAV patients without rituximab-intolerance.4 Our data suggest that obinutuzumab can be a relevant alternative for rituximab-intolerant AAV patients and potentially a cost-effective..."

Clinical • ANCA Vasculitis • Follicular Lymphoma • Hematological Malignancies • Inflammatory Arthritis • Leukemia • Lupus • Lymphoma • Oncology • Rheumatology • Systemic Lupus Erythematosus • Vasculitis

LOW RATE OF INFUSION-RELATED REACTIONS AND HIGH TREATMENT ADHERENCE WITH OBINUTUZUMAB IN PATIENTS WITH ACTIVE LUPUS NEPHRITIS: ANALYSIS OF THE NOBILITY AND REGENCY STUDIES (ERA 2025) - P2, P3 | " NOBILITY and REGENCY randomised adults with biopsy-proven active LN 1:1 to receive placebo (physiological saline) or obinutuzumab plus standard therapy (mycophenolate mofetil plus glucocorticoids)...To reduce the risk of IRRs, patients were premedicated with methylprednisolone (80 mg intravenously [IV]), acetaminophen (650-1000 mg) orally and an antihistamine orally or IV... Although the incidence of IRRs was higher in patients receiving obinutuzumab compared with placebo, the overall risk of IRRs was low, and IRRs also occurred in the placebo arm. In the majority of cases, IRRs were mild to moderate and managed by slowing or temporarily halting the infusion. IRRs primarily occurred at the first infusion in both arms and only 1 patient in the obinutuzumab arm had an IRR leading to discontinuation of study treatment."

Adherence • Clinical • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • CD20

ISS1.11 Multi-target treatments and a multidisciplinary approach: How they can improve care for patients with lupus nephritis (ERA 2025) - "The approval of belimumab and voclosporin represents a milestone in the management, and other substances such as obinutuzumab have met the primary endpoint of their approval trial and will likely be marketed soon...Management issues encountered by other specialities such as rheumatologists or dermatologists will be outlined and specific therapies approved for non-renal SLE, such as anifrolumab, will be discussed in this context.Besides treatment of active disease ("remission induction"), long-term prescription of immunosuppression is reality...While such an approach is invasive and often disregarded by affected patients, our symposium will outline that this is an essential point moving forward in the individualisation of therapy.In summary, relevant points for nephrologists are tackled from different perspectives in our symposium. These include the implementation of novel therapies in the management of SLE and LN, when referral to other specialities needs to be..."

Clinical • Chronic Kidney Disease • Fatigue • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

CLINICAL IMPACT OF ANTI-RITUXIMAB ANTIBODIES IN SMALL VESSEL VASCULITIS: A MULTICENTRIC RETROSPECTIVE STUDY (EULAR 2025) - "Following ARA detection, 78% (25/32) required a therapeutic switch, with obinutuzumab being the most frequently used alternative (50%), followed by cyclophosphamide, belimumab, and ofatumumab (9% each). This study provides the first comprehensive characterization of ARAs in small vessel vasculitis, highlighting their association with loss of RTX efficacy and persistent B-cell activity. Our findings suggest that ARAs negatively impact disease control, but switching to an alternative anti-CD20 agent may effectively restore B-cell depletion and induce remission. Future analyses will compare ARA-positive and ARA-negative patients to identify risk factors for ARA development and refine treatment strategies."

Retrospective data • ANCA Vasculitis • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • Rheumatoid Arthritis • Rheumatology • Septic Shock • Sjogren's Syndrome • Vasculitis • CRP

Advances and challenges in leukemia treatment: A focus on monoclonal antibodies and emerging therapies. (PubMed, Oncol Res) - "The biopharmaceutical compounds Ibrutinib, Obinutuzumab, Rituximab, Venetoclax, and Inotuzumab Ozogamicin were the ones that most appeared in the most recent publications, indicating the importance of amplifying the studies. Besides the adverse effects and overwhelming prices of the treatment, these immunotherapies results are promising, amplifying the survival rates, improving the patient's life quality, and resulting in a precision medicine, aiming a custom treatment. The future perspectives on this therapy consist of its application in the public health system, with patients being able to be submitted to this treatment without any costs and receive a better life quality."

Journal • Review • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

MP0533-CP101: Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - P1/2 | N=249 | Recruiting | Sponsor: Molecular Partners AG | N=70 ➔ 249 | Trial completion date: Dec 2027 ➔ Dec 2029 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=80 ➔ 4

Adverse events • Enrollment change • Enrollment closed • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Obinutuzumab Reduces Urinary Biomarkers of Lupus in Phase 2 NOBILITY Analysis (HCPLive) - P2 | N=126 | NOBILITY (NCT02550652) | Sponsor: Hoffmann-La Roche | "A secondary analysis of the NOBILITY trial is offering clinicians further insight into the safety and efficacy of obinutuzumab (Gazya/Gazyvaro) among patients with lupus nephritis (LN). The posthoc analysis...was presented at the 62nd European Renal Association (ERA 2025) Congress....Results of this latest analysis indicated use of obinutuzumab was associated with significantly greater reductions in urine CCL2, KIM1 and sCD163 and increases in urine EGF were observed relative to placebo therapy. Additionally, investigators pointed out there was a rapid and significantly greater decline in urine CCL2 and KIM1 levels were observed as early as week 12 and week 24, respectively, in the obinutuzumab group compared with the placebo group. Investigators also highlighted the presence of increased EGFR levels."

Biomarker • P2 data • Lupus Nephritis

Adverse events of interest (AEIs) with zanubrutinib vs fixed-duration combination of venetoclax + obinutuzumab in treatment-naive (TN) chronic lymphocytic leukemia (CLL). (ASCO 2025) - P3 | "Hematologic toxicity rates were lower with zanu vs VenO in the analysis time window. Rates of TEAEs leading to discontinuation and infections excluding COVID-19 were lower with zanu with a median tx duration of 23.9 mo. Continuing zanu monotherapy does not appear to increase the risk of infection, even with much longer tx duration, compared with fixed-duration VenO."

Adverse events • Chronic Lymphocytic Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Novel Coronavirus Disease • Oncology • Thrombocytopenia

Efficacy of continuous zanubrutinib vs fixed-duration venetoclax in combination with obinutuzumab in treatment-naive (TN) chronic lymphocytic leukemia (CLL): A matching-adjusted indirect comparison (MAIC). (ASCO 2025) - P3 | "This unanchored MAIC investigated the relative efficacy of zanu vs VenO and suggested zanu had longer PFS and a trend for extended OS. Results should be interpreted with considerations of MAIC model assumptions and limitations. Further studies are needed to confirm these findings."

Clinical • Combination therapy • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • B2M • IGH

Serious infections in patients with CLL/SLL treated with combination venetoclax and obinutuzumab compared with those treated with zanubrutinib: A real-world study. (ASCO 2025) - "This real-world study showed that patients diagnosed with CLL/SLL treated with VO had a higher risk of serious infections than those treated with zanu. In patients with a higher risk of infections, zanu could be considered as a treatment option in lieu of VO. Serious infections during 12- and 18-month follow-up period."

Clinical • Real-world • Real-world evidence • Chronic Lymphocytic Leukemia • Infectious Disease • Small Lymphocytic Lymphoma

Evaluating uptake of targeted agents by race/ethnicity in patients receiving first-line treatment for chronic lymphocytic leukemia (CLL). (ASCO 2025) - "Funded by BeiGene Background: The NCCN guidelines for first-line (1L) regimens in CLL have evolved over the past decade, shifting from ibrutinib (ibr) and chemoimmunotherapy (CIT) to second-generation BTK inhibitor and venetoclax combinations. Inequities in pts with CLL receiving preferred 1L tx suggests disproportionate use of CIT and ibr by race/ethnicity. Use of preferred TTs also differed by practice type and time period, with increased adoption after pivotal trials. VO, venetoclax + obinutuzumab aBy listing of NCCN preference (preferred vs other) among non-del17p and age >65"

Clinical • IO biomarker • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • IGH • TP53

Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. (ASCO 2025) - P3 | "We present updated efficacy and safety of Glofit-GemOx vs rituximab (R)-GemOx in pts with R/R DLBCL after ≥1 LOT from the Phase 3 STARGLO trial (NCT04408638), including landmark analyses of pts in complete remission (CR)...After obinutuzumab pretreatment, glofitamab was given in Cycle (C) 1 as weekly step-up doses (2.5/10mg) then 30mg target dose every 21 days from C2 Day 1... With 2 yrs follow-up, Glofit-GemOx sustained a clinically meaningful benefit in OS and PFS vs R-GemOx in ASCT-ineligible pts with R/R DLBCL, with most (82%) pts in CR at EOT still in remission. The safety profile was consistent with known risks of each drug. The updated analyses support the long-lasting remissions and maintained OS benefit in pts with R/R DLBCL treated with fixed duration Glofit-GemOx."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20