Update: Gazyva® significantly reduces disease activity in adults with systemic lupus erythematosus
The New England Journal of Medicine has published a detailed analysis of Genentech’s positive results from the Phase III ALLEGORY study of Gazyva® (obinutuzumab) for adults with systemic lupus erythematosus (SLE). The study met its primary endpoint, showing a clear, statistically significant, and clinically meaningful benefit.
The ALLEGORY study found nearly 77% of adults with moderate to severe SLE treated with Gazyva plus standard therapy achieved a clinically relevant improvement (≥4 point increase in SRI 4) at one year, compared with about 54% in the placebo group. Gazyva was more effective than placebo across all key study measures, including improving median time to first disease flares that can lead to lasting organ damage and more than doubling the number of study participants who achieved remission. All five key secondary endpoints were also met, including steroid reduction. If approved, Gazyva would be the first innovative Type II anti CD20 treatment that works by targeting B cells, which are key contributors to inflammation and disease.
Gazyva shows promise as a new standard of care for adults living with SLE. Discussions are ongoing with global health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency, to advance the regulatory process and enable timely availability of this potential new standard of care for people with SLE. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about SLE.