Genentech publishes REGENCY trial data in the New England Journal of Medicine

Genentech, a member of Roche (RHHBY), announced that a detailed analysis of its Phase III REGENCY trial of Gazyva in people with active lupus nephritis was published in the New England Journal of Medicine. The trial demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response, showing that 46.4% of people treated with Gazyva plus standard therapy achieved CRR at 76 weeks compared with 33.1% of people treated with standard therapy alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation. Data were presented at the World Congress of Nephrology 2025 and are being shared with health authorities, including the FDA and the European Medicines Agency. Gazyva’s safety profile was consistent with the well-characterized profile observed in its hematology-oncology indications. Key secondary endpoints showed that at week 76, patients who received Gazyva plus standard therapy were more likely to achieve CRR, with a successful reduction of corticosteroid use than standard therapy alone. In addition, a higher proportion of patients also showed improvement in proteinuric response when treated with Gazyva plus standard therapy versus standard therapy alone. These endpoints are important indicators for achieving better disease control in lupus nephritis. As seen in pre-specified subgroup analyses, a benefit in CRR with Gazyva over standard therapy alone was consistent across all subgroups of patients including indicators of more active lupus nephritis, Class IV lupus nephritis, concomitant Class V disease, higher baseline proteinuria levels, and/or greater serologic activity.