Genentech has announced promising results from the Phase III ALLEGORY study of its drug, Gazyva® (obinutuzumab), indicating a significant reduction in disease activity for adults with systemic lupus erythematosus (SLE). The study, which took place over the course of one year, demonstrated that a higher percentage of participants who received Gazyva experienced at least a four-point improvement in the SLE Responder Index 4 (SRI-4) compared to those on standard therapy.
The SRI-4 is a clinical tool used to assess changes in disease severity, symptoms, and physical condition, providing insight into the effectiveness of treatments aimed at controlling disease activity. According to the data released on November 3, 2025, all primary and key secondary endpoints of the ALLEGORY study were met, indicating that Gazyva may represent a new standard of care for SLE patients.
Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, emphasized the significance of these findings, stating, “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 may delay or prevent further organ damage in people with SLE.”
Key Study Findings
The ALLEGORY study involved approximately 300 participants who were randomly assigned to receive either Gazyva or a placebo for a duration of 52 weeks. Beyond the primary endpoint, results showed statistically significant and clinically meaningful benefits with Gazyva, including improvements in the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at week 52. Additional results indicated sustained corticosteroid control and a six-point improvement in the SLE disease activity score (SRI-6) at 52 weeks.
Gazyva also demonstrated a notable reduction in the time to the first flare, as defined by the British Isles Lupus Assessment Group (BILAG) index, over the same period. Importantly, no new safety signals were identified, with safety outcomes aligning with the established profile of Gazyva.
Impact on Systemic Lupus Erythematosus
SLE is a complex autoimmune disease that affects over three million people globally, predominantly women aged 15 to 45. This condition can lead to severe organ damage and complications, particularly through frequent disease flares. Approximately half of SLE patients progress to lupus nephritis, a serious kidney-related complication, within five years of diagnosis. The ability to control disease activity effectively is crucial in mitigating flares and preserving organ function.
Data from the ALLEGORY study will be presented at an upcoming medical conference and submitted to health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for review. If approved, Gazyva would be the first anti-CD20 therapy specifically targeting B cells, which play a pivotal role in the pathogenesis of SLE.
This study marks the third positive Phase III trial for Gazyva in the realm of immune-mediated diseases, following successful trials in lupus nephritis and idiopathic nephrotic syndrome. The accumulating evidence suggests that Gazyva’s mechanism of action—designed to target and destroy specific B cells—may prove beneficial across a variety of autoimmune conditions.
In addition to its application in SLE, Gazyva is currently being evaluated in children and adolescents with lupus nephritis, as well as adults with membranous nephropathy, reflecting Genentech’s commitment to advancing treatment options in immune-mediated diseases.
About Gazyva
Gazyva (obinutuzumab) is a humanized monoclonal antibody engineered for effective B cell depletion. It is currently approved in the United States for adults with lupus nephritis and is also authorized in over 100 countries for various hematological cancers. In October 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for Gazyva in the European Union, with a final decision from the European Commission anticipated soon.
As Genentech continues to pave the way in the field of immunology, the company remains focused on leveraging innovative science to address significant unmet medical needs for patients suffering from autoimmune diseases.
