Arzerra (ofatumumab) / Novartis, Genmab - LARVOL DELTA

Efficacy and Safety of Therapies for Pediatric Steroid-Resistant Idiopathic Nephrotic Syndrome: A Systematic Review of the Last Decade. (PubMed, Cureus) - "Interventions evaluated included tacrolimus (TAC), cyclosporine A (CsA), mycophenolate mofetil (MMF), cyclophosphamide (oral and intravenous), leflunomide (LEF), rituximab (RTX), and ofatumumab (OFA), mostly in combination with steroids. MMF appears favorable after RTX compared to CsA, while cyclophosphamide shows no advantage between oral and intravenous administration. Despite progress, evidence remains limited by small sample sizes and heterogeneity, underscoring the need for large-scale, multicenter trials to optimize therapeutic strategies."

Journal • Review • Chronic Kidney Disease • Glomerulonephritis • Hematological Disorders • Infectious Disease • Nephrology • Pediatrics • Renal Disease

The Addition of Inotuzumab Ozogamicin to Hyper-CVAD Plus Blinatumomab Further Improves Outcomes in Patients with Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia: Updated Results from a Phase II Study (ASH 2022) - "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 and to 2 cycles of blinatumomab consolidation (4 total cycles with INO)... The addition of INO to hyper-CVAD with sequential blinatumomab is safe and highly effective as frontline treatment of Ph-negative B-cell ALL. This study shows the feasibility of incorporating both INO and blinatumomab into the frontline treatment of pts with B-cell ALL. Outcomes of the pts treated in the INO cohort are particularly promising."

Clinical • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • CNS Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • Transplantation • ABL1 • CD20 • CRLF2 • KMT2A • NUP214 • POMP • TP53

Paraneoplastic cerebellar degeneration with anti-yo antibodies in serous ovarian carcinoma: A case report and literature review (ESGO 2026) - "Response to treatment is variable; first-line therapies include corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIG), while targeted agents such as rituximab or ofatumumab may be considered in refractory cases. A multidisciplinary approach involving neurologists, oncologists, and gynecologists is essential to optimize patient outcomes. Further prospective studies are needed to establish evidence-based therapeutic protocols for this challenging condition."

Case report • Clinical • Review • Breast Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • CDR2

Ofatumumab in AQP4-IgG Seropositive NMOSD (clinicaltrials.gov) - P1/2 | N=5 | Recruiting | Sponsor: Tang-Du Hospital | Trial completion date: Dec 2024 ➔ Jul 2026 | Trial primary completion date: Jun 2024 ➔ Apr 2026

Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Early-Stage Follicular Lymphoma: Learnings from the Final Analysis of the Multicenter Phase II FIL (Fondazione Italiana Linfomi) "Miro" Trial, Combining Local Radiotherapy and MRD-Driven Immunotherapy (ASH 2023) - "Pts who were MRD+ by both NEST and RQ in the BM a/o PB after IFRT or who became MRD+ during the follow-up were treated with 8 weekly doses of the anti-CD20 monoclonal antibody ofatumumab (OFA)...A consolidation strategy with more effective agent should be advisable. With these limits, a clinical advantage of the MRD-driven treatment strategy is suggested, although not largely applicable."

Clinical • IO biomarker • P2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • BCL2

Effect on disease activity of ofatumumab in the treatment of glial fibrillary acidic protein astrocytopathy and 18F-DPA714 PET/MRI imaging assessment. (PubMed, J Neuroimmunol) - "This case demonstrates the potential effect on disease activity and safety of OFA in GFAP-A treatment while highlighting the value of 18F-DPA714 PET as an innovative tool for monitoring neuroinflammation and therapeutic response. To our knowledge, this represents the first comprehensive multimodal assessment using 18F-DPA714 PET/MRI in a GFAP-A patient treated with ofatumumab."

Journal • Inflammation • Urinary Incontinence • GFAP

The efficacy and safety of anti-CD20 antibody for the treatment of B-ALL: a systematic review and meta-analysis. (PubMed, Ther Adv Hematol) - "According to the PRISMA guidelines, Embase, Cochrane Library, PubMed, Web of Science, and ClinicalTrials.gov were searched for clinical trials conducted up to November 1, 2024, for the evaluation of anti-CD20 antibodies (rituximab, obinutuzumab, and ofatumumab) and corresponding controls. Overall, anti-CD20 antibody therapy was more efficacious than the corresponding control and did not increase the incidence of grade 3-4 adverse events. Ofatumumab may be a more effective anti-CD20 antibody for the treatment of ALL."

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

Ofatumumab-mediated CD20+ B-cell depletion promotes neuromuscular junction functional recovery and sustains long-term efficacy in refractory generalized myasthenia gravis. (PubMed, Front Pharmacol) - "Ofatumumab provides durable clinical benefit and steroid-sparing effects, and its sustained depletion of CD20-positive B cells may facilitate recovery of neuromuscular junction transmission. These findings support its potential application within the field of regenerative pharmacology."

Journal • CNS Disorders • Myasthenia Gravis • CD20

Cellular and humoral vaccination response under immunotherapies-German consensus on vaccination strategies in neurological autoimmune diseases. (PubMed, Ther Adv Neurol Disord) - "The specific humoral and cellular response to vaccination can be compromised under alemtuzumab, azathioprine, cladribine, cyclophosphamide, CD19/CD20 antibodies (inebilizumab, ocrelizumab, ofatumumab, rituximab, ublituximab), dimethyl fumarate/diroximel fumarate, FcRn inhibitors (efgartigimod, rozanolixizumab), complement C5 inhibitors (eculizumab, ravulizumab, zilucoplan), interleukin-6 receptor antibodies (tocilizumab, satralizumab), intravenous immunoglobulins, long-term steroid administration, methotrexate, mitoxantrone, mycophenolate mofetil, tacrolimus, teriflunomide, tumor necrosis factor-α blockers, and sphingosine-1-phosphate receptor modulators (fingolimod, ozanimod, ponesimod, siponimod), as well as after autologous stem cell transplantation...However, the humoral and cellular vaccination response may be impaired under immunotherapy necessitating close monitoring. Here, we provide applicable recommendations to optimize immunization for individuals receiving..."

Journal • CNS Disorders • Immunology • Infectious Disease • Oncology • Transplantation • IL6R

Lattice light-sheet microscopy reveals patient specific responses to CD20-directed antibodies in B cell malignancies (ASH 2025) - "Introduction CD20-targeting monoclonal antibodies (mAbs) are in clinical use and standard of care in the treatment ofhematological malignancies and autoimmune diseases, including rituximab (RTX), obinutuzumab (OBZ)or ofatumumab (OFA)...In a third patient, who was in first relapse10 years after RTX-bendamustine therapy, the highest binding was observed for 2H7 whereas OBZ againshowed the lowest activity...LLS microscopy holds significant potential to support personalization ofimmunotherapies in hematologic malignancies by identifying the most effective mAb for each individualpatient. When integrated with genetic and molecular profiling, LLS microscopy will further contribute to abroader understanding of underlying mechanisms of organism-treatment interactions."

Clinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Immunology

Transformed Waldenström macroglobulinemia is associated with poor outcomes and chemorefractory disease (ASH 2025) - "Therapy prior to HT included rituximab (R) (n=4), Ofatumumab (Ofa) alone (n=1), R/Ofa-Benda based (n=12), BTKi (n=10), proteasome inhibitor-based (n=7), FCR (n=2), R-CHOP (n=1), R-Cytoxan(n=1), idealisib (n=1), and venetoclax (n=1)...Treatment for tWMincluded R-CHOP/Pola-R-CHP (70%), dose intense therapies [R-EPOCH, R-CODOX, HyperCVAD, RICE](17%), and 14% received other regimens [R-MPV, R-Cytoxan, R-CEPP]... Our single-center experience recapitulates the poor OS of tWM patients and reinforces theneed for further advances for this vulnerable population. The median time to relapse was less than 12months, suggestive of chemorefractory disease. The presence of CNS involvement significantlyinfluenced PFS."

IO biomarker • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Lymphoplasmacytic Lymphoma • Waldenstrom Macroglobulinemia • ARID1A • CD79B • CDKN2A • CXCR4 • MYD88 • TP53

The addition of inotuzumab ozogamicin to frontline hyper-CVAD and sequential blinatumomab leads to durable survival outcomes in adults with newly diagnosed B-cell acute lymphoblastic leukemia: Four-year follow-up of a phase 2 study (ASH 2025) - "Pts received Hyper-CVAD alternating with high-dosemethotrexate (MTX) and cytarabine (Ara-C) for up to 4 cycles, followed by 4 cycles of blina...Ofatumumab 2000 mg or rituximab 375 mg/m2 wasadministered in pts with CD20>1%...Pts received 12 ITchemotherapies and ursodiol.ResultsAs of July 2025, 75 pts were treated (38 without InO [cohort 1] and 37 with InO [cohort 2])...With death as a competing risk, the 4-year cumulative incidenceof relapse (CIR) rate was 18% for cohort 1 and 8% for cohort 2 (p = 0.177) and 4-year cumulativeincidence of death without relapse rate was 2% and 0% (p = 0.083), respectively.MVA for OS and EFS demonstrates that the administration of InO was the only favorable predictive factorfor OS (no InO HR 12.5; p=0.02) and borderline for EFS (no InO HR 3.15; p=0.06).There were no episodes of veno-occlusive disease.ConclusionFor pts with ND Ph-negative B-ALL, the addition of InO to Hyper-CVAD plus blina leads to promisingsurvival outcomes with the..."

Clinical • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Hepatology • Leukemia • CD20 • CD22 • CRLF2 • KMT2A

Hyper-CVAD versus hyper-CVAD plus blinatumomab for adult patients with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia: A propensity score analysis (ASH 2025) - P2 | "We,therefore, conducted a propensity matched analysis comparing the outcomes of pts with ND Ph-negative(-) B-ALL who received HCVAD vs. HCVAD and sequential blina.MethodsPts with ND Ph- B-ALL 18-60 years who received HCVAD with/without an anti-CD20 antibody(rituximab/ofatumumab) (NCT01363128) or HCVAD and sequential blina with/without inotuzumab(NCT02877303) were included...The duration of maintenance was reducedfrom 30 cycles of POMP (6-mercaptopurine, vincristine, methotrexate, prednisone) to 12 cycles with 1course of blina every third course for a total of 3 courses of blina...For matched Ph-like, the 3- and 5-year EFS rates were 63% and 50% vs. 83% and83% for HCVAD vs. HCVAD/blina, respectively (p=0.271), with 3- and 5-year OS rates of 63% vs. 100%respectively (p=0.099).MVA identified age (EFS HR 1.02 p=0.003 OS HR 1.024 p=0.013), smoking (EFS HR 1.8 p=0.003 OS HR 1.8p=0.01), BMI (EFS HR 1.06 p<0.001 OS HR 1.04 p=0.017), ECOG (EFS HR 2.1 p=0.01), KMT2Ar (EFS..."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • KMT2A

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

Monoclonal Antibodies as a Breakthrough in Personalised Leukaemia Therapy: What Pharmacists and Doctors Should Know. (PubMed, Pharmacy (Basel)) - "The drugs considered include blinatumomab, inotuzumab ozogamicin, gemtuzumab ozogamicin, rituximab, ofatumumab, obinutuzumab, and alemtuzumab. The review offers a comprehensive resource to equip pharmacists and other clinicians to optimise mAb therapy and promote the safe use of these novel therapies."

Journal • Review • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

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 • CNS Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • CD20 • KMT2A • TP53

Updated Results from a Phase II Study of Hyper-CVAD, with or without Inotuzumab Ozogamicin, and Sequential Blinatumomab in Patients with Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia (ASH 2023) - "Pts received hyper-CVAD alternating with high-dose methotrexate (MTX) and cytarabine (Ara-C) for up to 4 cycles, followed by 4 cycles of blinatumomab at standard doses. Pts with CD20+ disease (≥1% cells) received 8 doses of ofatumumab (2000 mg) or rituximab (375 mg/m2)...One pt discontinued blinatumomab due to a related adverse event (grade 2 encephalopathy and dysphasia). No pts discontinued INO due to toxicity, and no cases of veno-occlusive disease have been observed."

Clinical • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Central Nervous System Leukemia • CNS Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • ABL1 • CD20 • CRLF2 • KMT2A • NUP214 • TP53

Obinutuzumab in kidney transplantation: Past, present, and future. (PubMed, World J Transplant) - "Although frequently used to achieve B-cell depletion, the administration of the type 1 anti-CD20 monoclonal antibodies (mAb) rituximab (RTX) or ofatumumab (OFA) has failed to demonstrate a significant survival benefit. In patients with autoimmune glomerulopathies or multidrug-dependent nephrotic syndrome, OBI has shown encouraging results, representing a potential evolution of the treatment of post-transplant relapsing PRD. The present review summarizes the current knowledge on OBI use in KT setting."

Journal • Review • Antibody-mediated Rejection • Glomerulonephritis • Immunology • Nephrology • Renal Disease • Transplantation

Computational design of CAR-scFv linker variants for enhanced CD20 binding against B-cell malignancies. (PubMed, Comput Biol Med) - "To address this, we employed a molecular modeling strategy using Ofatumumab, a fully human monoclonal antibody, as the framework for engineering CAR-scFvs, focusing on their binding mode, stability, and affinity towards membrane-bound CD20...Notably, binding energy calculations indicated higher binding affinity of scFv-Whitlow (-37.12 kcal/mol) for CD20 compared to scFv-G4S3 (-27.97 kcal/mol), highlighting its superior interaction dynamics. These findings position scFv-Whitlow as a promising candidate for anti-CD20 CAR-T cell therapy and provide valuable insights for the rational design of next-generation CAR constructs targeting CD20."

Journal • Hematological Disorders • Hematological Malignancies • Oncology • CD20

Drug-induced headache reports: a comprehensive disproportionality and time-to-onset pharmacovigilance study using the FAERS database (2018-2024). (PubMed, Front Pain Res (Lausanne)) - "The drugs with the highest headache risk based on ROR included glecaprevir/pibrentasvir (ROR = 10.445), sofosbuvir/velpatasvir (ROR = 9.729), and eptinezumab-jjmr (ROR = 6.775). Top frequently reported drugs were apremilast, treprostinil, and adalimumab...Early-onset headaches (≤7days) were particularly associated with ofatumumab and fingolimod. Late-onset headaches (>90days) were linked to treprostinil and infliximab-dyyb. This large-scale pharmacovigilance study identifies multiple drugs and therapeutic classes with significant associations to headache as an ADR. These findings highlight the need for proactive headache monitoring, particularly during early treatment phases, and warrant further prospective investigations to understand mechanisms and preventive strategies."

Adverse events • Journal • Pain

Multi-Omics Exploration of Adaptive Mechanism to BTK Inhibition By Ibrutinib in CLL Identified TMBIM6/BI-1 As a Poor Prognosis Variable and Potential Therapeutic Target (ASH 2023) - P2 | " Blood samples from 28 patients from GELLC7 trial (NCT03280160, ibrutinib followed by ofatumumab consolidation) were collected before treatment (BT), and 1, 3, 6 and 12 months on treatment (at least two timepoints). Ibrutinib in T cells reduced the expression of exhaustion markers, Tregs and Tfh cells. In CLL cells, we observed a downregulation of markers related to adhesion, immunosuppression and migration, but an overexpression of TMBIM6 in CLL cells that retained migrative capacity towards CXCL12 under ibrutinib. Finally, we identified TMBIM6 expression as an independent poor prognostic factor and a potential novel target for CLL."

IO biomarker • Chronic Lymphocytic Leukemia • Oncology • Solid Tumor • BCL2L11 • BTLA • CCL19 • CCL2 • CCR7 • CD200 • CD44 • CD8 • CXCL10 • CXCL12 • CXCL13 • CXCR4 • CXCR5 • IGH • NFKBIE • PD-1 • PLCG2 • TMBIM6

Combination therapy of ofatumumab and daratumumab in patients with severe anti-NMDA receptor encephalitis. (PubMed, Front Immunol) - "We describe two adolescent female patients with severe neuropsychiatric manifestations unresponsive to standard first-line therapies, including intravenous methylprednisolone (IVMP) and intravenous immunoglobulins (IVIG). This case report demonstrates that combined treatment of ofatumumab and daratumumab therapy is well-tolerated and may represent a novel therapeutic strategy for severe NMDARE. The observed rapid serological and clinical responses highlight its potential efficacy, warranting further investigation in large cohorts."

Journal • CNS Disorders • Immunology • Psychiatry

Changes in Treatment Patterns over Time Among Real-World Patients with Follicular Lymphoma at Predominantly Community Facilities in the US (ASH 2024) - "For 2015–2018 vs 2019–2023, >80% of treatments were either R + chemo (consisting of R + bendamustine, R-CHOP, R-EPOCH, R-ICE, and similar therapies) (61% vs 58%) or R monotherapy (mono) (28% vs 25%). Chemo (mono or combination treatment with platinum-based therapies, cytarabine, vincristine, and similar), the third largest category, was unchanged (5% vs 5%). Small increases were seen in ofatumumab (OF) or obinutuzumab (OB) + bendamustine (2% vs 5%) and R + lenalidomide (R2) (1% vs 2%)...Increases were seen in R2 (2% vs 6%), OF and OB mono or with bendamustine (3% vs 7%), and lenalidomide or venetoclax mono (2% vs 5%)...Increases were seen in OF and OB monotherapy (1% vs 4%), R2 (5% vs 7%), lenalidomide or venetoclax mono (3% vs 9%), CAR-T (0% vs 2%), and tazemetostat (taz)-containing (0% vs 2%)...While mosunetuzumab, a bispecific monoclonal antibody (bsAb), was approved in late 2022, there were not sufficient pts to assess utilization...Utilization of newer therapies..."

Clinical • Real-world • Real-world evidence • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Deep Immune Profiling Identifies Novel T-Cell Subpopulations That Influence Specific Clinical Outcomes in Chronic Lymphocytic Leukaemia (CLL) (ASH 2023) - P3 | " The discovery cohort comprised pre-treatment samples from 79 CLL patients enrolled in the NCRI RIAltO trial (NCT01678430) who underwent factorial randomisation to ofatumumab and either bendamustine or chlorambucil, with or without idelalisib. The present study has identified three previously undescribed T-cell subpopulations that appear to influence the risk of infection, SPM, and death in patients with CLL receiving frontline chemo-immunotherapy. Further studies are warranted to validate these findings in the setting of targeted agents and in patients receiving CIT for other haematological malignancies."

Clinical • Clinical data • IO biomarker • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • CD27 • CD4 • CD8 • ICOS • PD-1 • TIGIT

High Dimensional Detection of Non-Malignant B-Cells and Its Clinical Implications in Patients with Chronic Lymphocytic Leukaemia (CLL) Undergoing Frontline Therapy (ASH 2023) - P3 | "Patients were randomly assigned to receive bendamustine or chlorambucil plus ofatumumab, with or without idelalisib. To our knowledge, this is the first study to identify correlations between the re-emergence of non-malignant B-cells following anti-CLL therapy and specific clinical endpoints such as haematopoietic recovery, serum Ig levels, TTP and OS. Although further validation is required in the context of targeted agents, our findings suggest that therapy-induced re-emergence of non-malignancy B-cells may have important biological and clinical implications in CLL."

Clinical • IO biomarker • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD20 • CD27 • CD5 • CD79B • CD81 • ROR1 • SPN