Arzerra (ofatumumab) / Novartis, GSK, Genmab - LARVOL DELTA

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

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

Long-term outcomes of patients with Primary FSGS treated with Rituximab (ERA 2025) - "2/5 were re-treated with RTX, 2/5 were treated with steroids and maintenance RTX/ofatumumab, 1/5 was treated with tacrolimus and maintenance ofatumumab. The long-term data from this study suggests that RTX may be effective for achieving and maintaining remission in patients with difficult to treat primary FSGS with a favourable long-term safety profile. Sustained B cell depletion with maintenance RTX dosing was required to achieve a response (at median time of 9.2 months). Response was associated with improved long-term outcomes, but patients do relapse."

Clinical • Diabetes • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Immunology • Infectious Disease

Interventions for idiopathic steroid-resistant nephrotic syndrome in children. (PubMed, Cochrane Database Syst Rev) - "Calcineurin inhibitors may increase the likelihood of complete or partial remission compared with placebo/no treatment or cyclophosphamide. For other regimens, it remains unclear whether the interventions alter outcomes because the certainty of the evidence is low. Further adequately powered, well-designed RCTs are needed to evaluate other regimens for children with idiopathic SRNS. Since SRNS represents a spectrum of diseases, future studies should enrol children from better-defined groups of people with SRNS."

Clinical • Journal • Review • Cardiovascular • Dermatology • Glomerulonephritis • Hypertension • Infectious Disease • Nephrology • Pediatrics • Renal Disease • Transplantation

THE PROGNOSTIC ROLE OF NEUTROPHIL-TO-LYMPHOCYTE RATIO (NLR) IN WALDENSTRÖM MACROGLOBULINEMIA: AN INDEPENDENT PROGNOSTIC MARKER (EHA 2025) - "However, the response rate to Immunotherapy (Rituximab or ofatumumab) was less among those with high NLR, combined complete response (CR) and very good partial response (VGPR) was 77 % vs 84%, P<0.005. Our study identifies NLR as a simple, cost-effective, and independent prognostic marker in WM. High NLR at diagnosis is associated with worse mOS, higher bone marrow infiltration, increased risk of transformation to DLBCL, and inferior response to immunotherapy. These findings support the role of systemic inflammation in WM progression."

Biomarker • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Monoclonal Gammopathy • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

Real-world data of 535 Japanese patients using ofatumumab (JSNE 2025) - "Co-sponsored by: Novartis Pharma K.K."

Clinical • Real-world • Real-world evidence

Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL (clinicaltrials.gov) - P2 | N=45 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Sep 2024

Trial completion • Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD20 • CD5

CALGB-50904: Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • CD4

Obinutuzumab and Ofatumumab are More Effective Than Rituximab in the Treatment of Membranous Nephropathy Patients With Anti-Rituximab Antibodies. (PubMed, Kidney Int Rep) - "Obinutuzumab and ofatumumab are more effective than rituximab in treating patients with membranous nephropathy with anti-rituximab antibodies. Anti-rituximab antibodies should be systematically monitored, to determine appropriate treatment."

Clinical • Journal • Glomerulonephritis • Nephrology • Renal Disease

A randomized, controlled, multicenter, open-label clinical trial of the efficacy and safety of B cell depletion followed by daratumumab in the treatment of autoimmune encephalitis (ChiCTR) - P3 | N=200 | Not yet recruiting | Sponsor: the First People's Hospital of Changzhou; the First People's Hospital of Changzhou

New P3 trial • CNS Disorders • Immunology

Ofatumumab for the treatment of COVID-19-associated autoimmune encephalitis: A case report. (PubMed, J Neuroimmunol) - "Nevertheless, his clinical symptoms and cranial MRI abnormalities markedly improved following the administration of Ofatumumab. Administering Ofatumumab early in COVID-19-related autoimmune encephalitis may benefit patients more."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Epilepsy • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

RADIA: Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: The First People's Hospital of Changzhou | Active, not recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology

CDSCO Panel Approves Updated Package Insert For Novartis' Ofatumumab Injection (Medical Dialogues) - "The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the proposal presented by the drug major Novartis for update in package insert for the drug product Ofatumumab solution for injection in pre-filled syringe of 20 mg/0.4 mL with changes in sections of contraindications, warnings and precautions, patient counseling information and instructions for use....This came after the firm presented the proposal for an update in the package insert for the drug product Ofatumumab solution for injection in a pre-filled syringe of 20 mg/0.4 mL based on the U.S. pack insert dated 12 April 2024 with changes in Sections of Contraindications, Warning and Precaution, Patient Counseling Information, and Instructions for Use."

Commercial • Multiple Sclerosis

Enhancing complement activation by therapeutic anti-tumor antibodies: Mechanisms, strategies, and engineering approaches. (PubMed, Semin Immunol) - "At the same time, preclinical and clinical studies on antibodies such as rituximab, ofatumumab, and daratumumab have provided evidence for the role of complement in therapeutic success, encouraging strategies to further enhance its activity. Finally, we highlight the potential of complement-dependent cellular cytotoxicity (CDCC) and complement-dependent cellular phagocytosis (CDCP) as effector mechanisms that warrant deeper investigation. By integrating advances in antibody and complement biology with insights from efforts to enhance complement activation in therapeutic antibodies, this review aims to provide a comprehensive framework of antibody design and engineering strategies that optimize complement activity for improved anti-tumor efficacy."

Journal • Review • Infectious Disease • Oncology

RADIA: Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis (clinicaltrials.gov) - P3 | N=200 | Active, not recruiting | Sponsor: The First People's Hospital of Changzhou

New P3 trial • CNS Disorders • Immunology

Real-world-data on Ofatumumab as First-line Treatment in Early RMS (AIOLOS study) (AAN 2025) - "Objective:The non-interventional study (NIS) AIOLOS evaluates ofatumumab, interferon β1 (IFN-β1) or glatiramer acetate (GA) in treatment-naïve RMS patients who do not meet the highly-active disease criteria in daily clinical routine in Germany.Background:Ofatumumab, a fully human monoclonal aCD20 antibody, showed superior efficacy and comparable safety versus teriflunomide in the Phase 3 ASCLEPIOS I/II overall population and in various subgroups, including recently diagnosed treatment-naive and in non-highly active participants...This interim analysis on real-world use of ofatumumab in treatment-naive RMS patients who do not meet the highly-active disease criteria is in line with data from the pivotal ofatumumab trials and confirms the favorable benefit-risk profile of ofatumumab as first-line treatment. The data provide insights into the RMS patient population treated with different self-administered first-line therapies."

Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis • IFNB1

Efficacy and Safety of Ofatumumab Treatment for Anti-NMDA Receptor Autoimmune Encephalitis (OFF-AE): A Prospective, Multicenter Cohort Study. (PubMed, Ann Neurol) - "Ofatumumab showed substantial efficacy and safety, particularly in patients who failed first-line immunotherapy, warranting its consideration in NMDAR-AE management. ANN NEUROL 2025."

Journal • CNS Disorders • Immunology

A single center experience of obinutuzumab in children with refractory kidney disease (IPNA 2025) - "Methods All children who received Obinutuzumab (1000 mg/1.73 m2/dose) and one received Ofatumumab (300 mg/1.73 m2/dose) were included in the study...Initial therapy: All patients received steroids; Rituximab= 20 (69%), CNI (tacro/CSA) = 19 (66%), MMF= 17 (59%), Cytoxan =7 (30%)...We noted significant reduction in proteinuria and average improvement of 33% in eGFR in children after failure of standard therapies. All patients were able to be weaned off the steroids, 75% had complete remission and 24% were off all medications."

Clinical • B Cell Lymphoma • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • IgA Nephropathy • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Pneumonia • Renal Disease • Respiratory Diseases • Septic Shock • Varicella Zoster

Ofatumumab & Ibrutinib + Allogeneic Bone Marrow Transplant or Consolidation in High Risk Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto | Active, not recruiting ➔ Completed | Trial completion date: Aug 2025 ➔ Apr 2024 | Trial primary completion date: Aug 2025 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Transplantation

Drug exposure and measurable residual disease in chronic lymphocytic leukemia: a systematic review. (PubMed, Leuk Lymphoma) - "Undetectable MRD was associated with higher trough concentrations of ofatumumab and alemtuzumab, as well as increased maximum concentration and area under the plasma concentration curve (AUC) of ibrutinib. One study found an association between high rituximab AUC and undetectable MRD until adjusting for tumor burden. The limited studies, lack of exposure measurements of concomitant drugs, and high heterogeneity in designs limit the results' generalizability. Further research is needed to explore the exposure-MRD relationship and the possibility for therapeutic drug monitoring in CLL."

Clinical • Journal • Review • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Decoding the molecular interplay of CD20 and therapeutic antibodies with fast volumetric nanoscopy. (PubMed, Science) - "Combining TDI-DNA-PAINT and LLS microscopy on immunological B cells revealed the oligomeric states and interaction of endogenous CD20 with the therapeutic monoclonal antibodies (mAbs) rituximab, ofatumumab, and obinutuzumab. Our results demonstrate that CD20 is abundantly expressed on microvilli that bind mAbs, which leads to an antibody concentration-dependent B cell polarization and stabilization of microvilli protrusions. These findings could aid rational design of improved immunotherapies targeting tumor-associated antigens."

Journal • Oncology • CD20

Potentiating CD20 monoclonal antibody therapy by targeting complement C3 fragment covalently deposited on lymphoma cells. (PubMed, Blood) - "Anti-C3d rabbit/human chimeric IgG1 in combination with ofatumumab or rituximab prolonged survival of xenografted mice that model three different types of non-Hodgkin lymphoma (NHL). In long-term survivors from both cohorts, there was no evidence of adverse effects. We propose that C3d mAbs combined with complement fixing CD20 mAbs can deliver a one-two punch and increase efficacy of mAb-based therapy."

Journal • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CTCs

Relative Efficacy of Systemic Treatments for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: A Network Meta-Analysis According to 17p Deletion/TP53 Mutations (ASH 2024) - "Ibrutinib was used as reference treatment.Results : Twelve trials involving 4,437 patients and 13 treatment options were included in the meta-analysis : three Bruton tyrosine kinase (BTK) inhibitors (ibrutinib, acalabrutinib, and zanubrutinib), two BTK inhibitors combined with other treatments (ibrutinib plus rituximab plus bendamustine [RB] and ibrutinib plus rituximab), two phosphoinositide 3-kinase (PI3K) inhibitors (idelalisib and duvelisib), three PI3K inhibitors combined with other treatments (idelalisib plus ofatumumab, idelalisib plus RB, idelalisib plus rituximab), three anti-CD20-based treatment (RB, ofatumumab, and rituximab), and one BCL-2 inhibitor (venetoclax plus rituximab). In the 17p deletion/TP53 mutation subgroup, zanubrutinib demonstrated the most favorable efficacy (HR 0.52, 95% CI 0.31-0.88 versus ibrutinib) with the highest SUCRA value (97%). For patients without these mutations, venetoclax plus rituximab was the most effective (HR 0.49, 95% CI..."

IO biomarker • Retrospective data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • TP53

Updated Results from a Phase II Study Hyper-CVAD, with or without Inotuzumab Ozogamicin, and Sequential Blinatumomab in Patients with Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia (ASH 2024) - "Pts with CD20+ disease (≥1% cells) received 8 doses of ofatumumab (2000 mg) or rituximab (375 mg/m2)...Beginning with pt #39, INO at a dose of 0.3 mg/m2 on day 1 and 8 was added to the 2 cycles of MTX/Ara-C (dose reduced to 500 mg/m2 of MTX and 1 g/m2 of Ara-C) and to 2 cycles of blinatumomab consolidation (4 total cycles with INO)...Conclusion In pts with newly diagnosed Ph-negative B-ALL, the addition of INO to the hyper-CVAD + blinatumomab appears to improve OS. To confirm these findings, this study now randomizes pts to hyper-CVAD + blinatumomab ± INO."

Clinical • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • CNS Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • CD20 • KMT2A • TP53

PC-002 (Sepantronium Bromide) Enhances the Antitumor Efficacy of Anti-CD20 Antibody By CD20 Upregulation (ASH 2024) - "P493 tet-off cells were treated with tetracycline to suppress the expression of c-Myc (Myc-off)...Furthermore, mouse xenografts (RAMOS, SU-DHL-4, SU-DHL-10 and OCI-LY7) were established to evaluate the efficacy of YM155 (2 mg/kg, 168-hour-infusion) in combination with anti-CD20 antibody, including Rituximab, Ripertamab and Ofatumumab in vivo...Moreover, the up-regulation of CD20 after PC-002 treatment in RFP/Luc cells was confirmed by whole transcriptome analysis. These results indicate that PC-002 enhances the efficacy of anti-CD20 antibody by downregulating c-Myc, and support the planned clinical investigation of the combination of PC002 with an anti-CD20 antibody such as rituximab in patients with relapsed/refractory c-Myc driven Burkitt lymphoma or diffuse large B-cell lymphoma.Conclusion : In conclusion, our preclinical data highlight the potent anti-tumor effects of PC-002 in combination with anti-CD20 antibody in patients with DLBCL and BL, and warrant the planned..."

Clinical • B Cell Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Orthopedics • Solid Tumor • Targeted Protein Degradation • MYC • USP7