Genentech's Gazyva Reduces Lupus Disease Activity in Phase III Trial
- Phase III ALLEGORY trial data published in NEJM.
- 76.7% of Gazyva-treated patients showed a four-point SRI-4 improvement.
- Gazyva doubled remission rates to 35.1% compared to placebo.
- Data presented at the 15th European Lupus meeting, SLEuro 2026.
Study Publication
The New England Journal of Medicine published detailed results from the Phase III ALLEGORY trial, evaluating Gazyva (obinutuzumab) in adults with systemic lupus erythematosus (SLE).
Key Findings
The trial showed that 76.7% of patients treated with Gazyva plus standard therapy achieved at least a four-point improvement in the SLE Responder Index 4 (SRI-4) at 52 weeks, compared to 53.5% with placebo plus standard therapy. The adjusted difference was 23.1%, with a 95% confidence interval of 12.5-33.6, and a p-value of less than 0.001.
Secondary Endpoints
Gazyva was superior to placebo in all key and additional secondary endpoints. It improved the median time to first flare, as defined by the British Isles Lupus Assessment Group (BILAG) index, with a hazard ratio of 0.58 and a p-value of 0.002. The remission rate more than doubled, reaching 35.1% compared to 13.8% with placebo, with an adjusted difference of 21.2%.
Conference Presentation
These findings were also presented at the 15th European Lupus meeting, SLEuro 2026, highlighting the potential of Gazyva to become a new standard of care for SLE by directly targeting B cells, a key driver of inflammation and disease activity.
Source: Genentech