Roche’s Gazyva Shows Strong Phase III Success in Systemic Lupus: ALLEGORY Trial Published in NEJM

Roche reported that results from the Phase III ALLEGORY trial (NCT04963296) evaluating Gazyva®/Gazyvaro® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) have been published in the New England Journal of Medicine and presented at the European Lupus Meeting (SLEuro 2026). The study showed that adding obinutuzumab to standard therapy significantly improved disease activity compared with placebo.

The randomized, double-blind, placebo-controlled study enrolled about 300 adults with active SLE receiving standard treatment. At week 52, the trial met its primary endpoint: 76.7% of patients treated with Gazyva/Gazyvaro achieved at least a four-point improvement in the SLE Responder Index (SRI-4) compared with 53.5% in the placebo group (adjusted difference 23.1%; p<0.001).

The therapy also improved several key secondary outcomes. Time to first disease flare was significantly longer, and remission rates were more than doubled with obinutuzumab (35.1% vs 13.8% with placebo). Additional endpoints, including BICLA response and sustained glucocorticoid reduction, were achieved.

The safety profile was consistent with the known safety of obinutuzumab, with no new safety signals identified.

Dr. Richard Furie, Chief of Rheumatology at Northwell Health and a study investigator, said the findings highlight the potential of B-cell targeting to reduce lupus disease activity and improve long-term disease control.

Roche’s Chief Medical Officer Levi Garraway added that the results suggest the therapy could help address the long-standing need for treatments that reduce disease flares and steroid burden in SLE.

ALLEGORY adds to Roche’s expanding clinical evidence for obinutuzumab in immune-mediated diseases. The company has previously reported positive studies in lupus nephritis (NOBILITY and REGENCY), idiopathic nephrotic syndrome (INShore), and primary membranous nephropathy (MAJESTY). While those trials focused largely on kidney-related autoimmune conditions, ALLEGORY evaluated systemic lupus erythematosus more broadly, extending the potential role of B-cell targeting across the lupus disease spectrum.

Gazyva/Gazyvaro is a Type II anti-CD20 monoclonal antibody designed to enhance B-cell depletion through direct cell death and increased antibody-dependent cellular cytotoxicity. The therapy is already approved in the United States and European Union for adults with lupus nephritis and in over 100 countries for several hematologic cancers.

Systemic lupus erythematosus affects more than three million people worldwide, most commonly women aged 15–45. The autoimmune disease causes chronic inflammation and can damage multiple organs. Around half of patients develop lupus nephritis within five years, increasing the risk of kidney failure.

Roche said it is discussing the ALLEGORY results with global regulators, including the U.S. FDA and the European Medicines Agency, to support potential approval of Gazyva/Gazyvaro for systemic lupus erythematosus.

Reference

New England Journal of Medicine publishes phase III ALLEGORY data showing Roche’s Gazyva/Gazyvaro significantly reduces disease activity in the most common form of lupus, 06 March 2026, https://www.roche.com/media/releases/med-cor-2026-03-06

Richard A. Furie et al, Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus, The New England Journal of Medicine, Published March 6, 2026, Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus | New England Journal of Medicine

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus (ALLEGORY), ClinicalTrials.gov ID NCT04963296, Study Details | NCT04963296 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus | ClinicalTrials.gov