Global healthcare giant Roche has announced that a detailed analysis of the phase III ALLEGORY trial of Gazyva/Gazyvaro (obinutuzumab) in adults with systemic lupus erythematosus (SLE) has shown a statistically significant and clinically meaningful benefit in the primary endpoint.

 

The treatment directly targets B cells, a root cause of disease, as per the company.

 

The trial revealed that 76.7% of patients receiving Gazyva/Gazyvaro plus standard therapy achieved at least a four-point improvement in the SLE Responder Index 4 at 52 weeks, compared to 53.5% for those on placebo plus standard therapy — an adjusted difference of 23.1%.

 

Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints, including a longer median time to first flare — a measure of organ-damaging disease activity — and more than doubling the remission rate (35.1% versus 13.8%, adjusted difference.

 

“The ALLEGORY study of Gazyva represents one of the most compelling late-stage successes in years for the treatment of patients with systemic lupus erythematosus (SLE), showing important evidence that targeting B cells can deliver significant reductions in disease activity,” said Dr Richard Furie, Chief of the Division of Rheumatology at Northwell Health and professor in the Institute of Molecular Medicine at the Feinstein Institutes for Medical Research. 

 

“With the ALLEGORY study, we are seeing the potential to deliver more robust and sustained disease control with less reliance on steroids. These benefits matter profoundly to patients, physicians and families, marking Gazyva as an important step forward in the treatment of this autoimmune disease.”

 

“For decades, people living with SLE have faced a cycle of unpredictable disease activity, limited treatment options and long-term steroid burden. These results from the ALLEGORY trial show that Gazyva/Gazyvaro can provide significant, clinically meaningful, and sustained disease control, which is critical to preventing life threatening damage to major organs,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. 

 

“We look forward to working with health authorities around the world to bring this potentially transformative new treatment to patients with lupus as quickly as possible.”

 

Roche is currently discussing the data with global health authorities, including the US Food and Drug Administration and the European Medicines Agency, aiming to make Gazyva/Gazyvaro the first Type II anti-CD20 therapy for SLE available as a potential new standard of care.