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 | Not yet recruiting | Sponsor: BeiGene

New P3 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL" (clinicaltrials.gov) - P2 | N=124 | Recruiting | Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2023 ➔ Dec 2025

Enrollment open • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD20

Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Joseph Tuscano | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Oct 2024 ➔ Apr 2026

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

OBI-WAN: Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris

New P2 trial • Rare Diseases • Vasculitis

Gazyva: Regulatory submission in Japan for lupus nephritis in 2026 (Chugai) - Q1 FY2025 Results: Regulatory submission in Japan for extra renal lupus in 2027

Japan filing • Lupus • Lupus Nephritis

Gazyva: Data from P3 ALLEGORY trial (NCT04963296) for SLE in 2025 (Roche) - Q1 2025 Results

P3 data • Systemic Lupus Erythematosus

Gazyva: Regulatory submissions in US/EU for SLE in 2026 (Roche) - Q1 2025 Results

EMA filing • FDA filing • Systemic Lupus Erythematosus

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) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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

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 | "Clinical Trial Registration Number: NCT03336333, NCT02242942 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Adverse events • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

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) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A global anti B cell strategy combining Obinutuzumab and Daratumumab for Treatment of Antibody-Mediated Rejection in Pediatric Kidney transplantation (PAS 2025) - "Background: Antibody-mediated rejection (AMR) is a leading cause of kidney transplant failure and poses unique challenges in pediatric patients, especially in cases refractory to conventional therapies such as plasmapheresis, intravenous immunoglobulin (IVIG), and rituximab. Initial and post-treatment measurements showed creatinine levels reduced from 2 mg/dL to 1.45 mg/dL, and AlloSure levels dropped from 1.35% to 0.28%. Additionally, reductions in HLA DSAs were more effective for Class I than Class II antibodies. The combination therapy led to significant improvements in renal function, with reductions in serum creatinine (p < 0.05) and dd-cfDNA (p < 0.01), suggesting reduced allograft injury and improved renal function."

Clinical • Antibody-mediated Rejection • Pediatrics • Transplantation

Successful Treatment of Ocular Post-Transplant Lymphoproliferative Disorder with Obinutuzumab in an 8-Year-Old Boy Following Kidney Transplant: A Case Report. (PubMed, Ocul Immunol Inflamm) - "Initial treatment with systemic rituximab led to recurrence after 6 months. This case highlights the importance of early recognition and multidisciplinary management in PTLD. It also emphasizes the delicate balance between immunosuppression and antitumor therapy in transplant recipients, aiming to preserve graft function while effectively treating PTLD."

Journal • Epstein-Barr Virus Infections • Ocular Inflammation • Oncology • Ophthalmology • Transplantation • Uveitis

LYMA-101: Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance (clinicaltrials.gov) - P2 | N=86 | Completed | Sponsor: The Lymphoma Academic Research Organisation | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Transplantation • CCND1 • CD20 • CD5

Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=27 | Not yet recruiting | Sponsor: OHSU Knight Cancer Institute | Trial completion date: May 2029 ➔ Nov 2029 | Trial primary completion date: May 2027 ➔ Nov 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

An autopsy for persistent coronavirus disease 2019 pneumonia during follicular lymphoma treatment: A case report. (PubMed, Intern Med) - "Therefore, remdesivir was administered to the patient...Autopsy revealed diffuse alveolar damage. In high-risk patients with hematologic malignancy, COVID-19 vaccination should be repeated at shorter intervals to avoid increasing the viral load during the COVID-19 infection."

Journal • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases

Zanubrutinib Plus Venetoclax and Obinutuzumab Yields Deep Remissions in Patients With Chronic Lymphocytic Leukemia (Pharmacy Times) - P2 | N=42 | NCT04515238 | "Zanubrutinib (Brukinsa; BeiGene), venetoclax (Venclexta; AbbVie Inc), and obinutuzumab (Gazyva; Genentech) demonstrated significant improved undetectable minimal residual disease (uMRD)-negativity and yielded deep remissions in patients with chronic lymphocytic leukemia (CLL) in the phase 2 CLL2-BZAG trial (NCT04515238)....They assessed a total of 42 patients who previously received a median of 1 prior line of therapy (range 1 to 5), of which 45% were treated with BTK inhibitors, 17.5% received venetoclax, and 12.5% previously received both. The population had a median age of about 64 years, and 67.5% were male. The primary end point of the analysis is the uMRD rates, with other key end points including safety, progression-free survival (PFS), and overall survival (OS)."

P2 data • Chronic Lymphocytic Leukemia

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) - No abstract available

Clinical • P3 data • Glomerulonephritis • Nephrology • 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) - No abstract available

Biomarker • P2 data • Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Effectiveness and Remission Predictors of Obinutuzumab in Primary Membranous Nephropathy (ERA 2025) - No abstract available

Clinical • Glomerulonephritis • Renal Disease

Obinutuzumab alone may be an effective option for the initial therapy of adult minimal change disease (ERA 2025) - No abstract available

Clinical • Glomerulonephritis

Obinutuzumab in rituximab-intolerant ANCA-associated vasculitis patients (ERA 2025) - No abstract available

Clinical • ANCA Vasculitis • Vasculitis

Obinutuzumab in Steroid-Resistant Podocytopathies (ERA 2025) - No abstract available

Renal Disease

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) - No abstract available

Adherence • Clinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

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 • Dermatology • Fatigue • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Rheumatology • Systemic Lupus Erythematosus

Clinical characteristics, treatment patterns and outcomes of patients with follicular lymphoma in Colombia: a real-world evidence cohort study. (PubMed, Ann Hematol) - "Most frequent first line (1 L) treatments were R-CHOP (63.5%) and R-CVP (10.8%), with 77.3% of patients achieving complete response (CR)...Most frequent 2L treatments were radiotherapy (23%), obinutuzumab-based regimens (18%) and R-Bendamustine (18%)...Findings showed high response rates to initial treatment and prolonged overall survival. The presence of a high FLIPI score and POD24 were associated with an increased risk of mortality."

HEOR • Journal • Real-world evidence • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology