Roche’s Gazyva Achieves Positive Phase III Results In Systemic Lupus Erythematosus; ALLEGORY Trial Confirms Efficacy And Safety, Meeting All Endpoints

Roche announced positive top-line results from the Phase III ALLEGORY study, demonstrating that Gazyva®/Gazyvaro® (obinutuzumab) achieved statistically significant and clinically meaningful improvements in adults with systemic lupus erythematosus (SLE) receiving standard therapy. The trial met its primary endpoint, showing a greater proportion of patients achieving a minimum four-point improvement in the SLE Responder Index 4 (SRI-4) at 52 weeks compared with standard therapy. All key secondary endpoints were also met, including improvements in disease activity, sustained corticosteroid control, and flare reduction, with no new safety signals identified.

“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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

The ALLEGORY study showed that treatment with Gazyva/Gazyvaro led to statistically significant benefits across multiple disease measures, such as BICLA response, sustained SRI-4 response, and time to first flare over one year. These findings support Gazyva/Gazyvaro’s potential to improve disease control, reduce flares, and help prevent long-term organ damage in people with SLE. The drug’s safety profile was consistent with its well-established use in other autoimmune indications, reinforcing its favorable benefit-risk profile.

Systemic lupus erythematosus (SLE) affects over three million people worldwide, predominantly women aged 15–45, with women of color disproportionately affected. Frequent disease flares can lead to inflammation and irreversible organ damage, with nearly half of patients developing lupus nephritis within five years. Roche plans to present full data at an upcoming medical meeting and share results with global health authorities, including the U.S. FDA and EMA. If approved, Gazyva/Gazyvaro would become the first anti-CD20 therapy for SLE, expanding its role beyond oncology and nephrology. This marks the third positive Phase III trial for Gazyva/Gazyvaro in immune-mediated diseases, highlighting its potential to redefine treatment across autoimmune conditions.