Roche’s Gazyva shows breakthrough efficacy in phase III lupus study

The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response

Roche announced positive topline results from the Phase III ALLEGORY study evaluating Gazyva (obinutuzumab) in adults with systemic lupus erythematosus (SLE) receiving standard therapy. The study achieved its primary endpoint, showing that a significantly higher percentage of patients treated with Gazyva achieved a minimum four-point improvement in the SLE Responder Index 4 (SRI-4) at 52 weeks compared with those on standard therapy. All key secondary endpoints were also met, demonstrating consistent and clinically meaningful benefits across multiple measures of disease activity.

No new safety signals were identified, and the safety profile of Gazyva remained consistent with previous findings.

“Systemic lupus erythematosus is a lifelong autoimmune condition that can cause irreversible organ damage and lead to life-threatening complications,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “These pivotal results are unprecedented, showing that by effectively controlling disease activity, Gazyva may delay or prevent further organ damage in people living with SLE. We look forward to working closely with health authorities to make this potentially transformative treatment available to patients as soon as possible.”

The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response, sustained corticosteroid control, sustained SRI-4 response, SRI-6 improvement at week 52, and reduced time to first disease flare. These findings suggest that Gazyva provides durable disease control and may help limit long-term organ damage in patients with SLE.

SLE affects more than three million people globally, the majority being women aged 15 to 45, with women of colour disproportionately affected. The disease often leads to chronic inflammation and damage to multiple organs, and nearly half of all patients develop lupus nephritis—a severe and potentially life-threatening kidney complication—within five years of diagnosis. Achieving sustained disease control can reduce flares, preserve organ function, and lower the risk of progression to lupus nephritis.

The data from ALLEGORY will be presented at an upcoming medical congress and submitted to regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for review. If approved, Gazyva would become the first anti-CD20 therapy for SLE to directly target B cells, a key driver of inflammation and disease activity.

ALLEGORY marks the third positive Phase III study for Gazyva in immune-mediated diseases, following the successful REGENCY trial in lupus nephritis and the INShore trial in idiopathic nephrotic syndrome. This growing body of evidence reinforces the potential of Gazyva, designed for enhanced B-cell depletion, to address disease activity across a range of autoimmune and immune-related conditions.

In addition to SLE, Roche continues to investigate Gazyva/Gazyvaro in children and adolescents with lupus nephritis and in adults with membranous nephropathy, as part of its commitment to advancing innovation in immune-mediated rheumatology and nephrology.