Roche Announces Promising Phase III Success for Gazyva in SLE

Roche today reported positive Phase III results for Gazyva (obinutuzumab) in adults with systemic lupus erythematosus (SLE) receiving standard therapy.

The ALLEGORY study met its main goal, showing more patients achieved a four-point improvement in the SLE Responder Index (SRI-4) at 52 weeks compared with standard therapy alone.

All key secondary goals were also reached, including sustained corticosteroid control, time to first flare, and improvement in disease activity scores. No new safety issues were seen, and the profile of Gazyva matched previous studies.

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Dr. Levi Garraway, Roche’s Chief Medical Officer, said “Systemic lupus erythematosus is a lifelong condition that can cause irreversible damage to the major organs in the body, leading to life-threatening complications. These pivotal results are unprecedented in demonstrating that by effectively controlling disease activity, Gazyva/Gazyvaro may delay or prevent further organ damage in people with SLE.”

“We look forward to sharing the data with global health authorities, with the goal of making this potentially transformative new standard of care available as quickly as possible,” he added.

The results will be presented at an upcoming medical meeting and shared with the US Food and Drug Administration and European Medicines Agency. If approved, Gazyva would become the first anti-CD20 therapy for SLE, targeting B cells that drive disease activity.

The ALLEGORY trial included around 300 participants across several centres, confirming Gazyva’s potential to reshape treatment for autoimmune diseases. Already approved for lupus nephritis and certain blood cancers, Gazyva continues to show strong results in immune-related conditions, reinforcing Roche’s position in rheumatology and nephrology research.