Roche’s Gazyva Shows Promising Results in Phase 3 Lupus Nephritis Trial, Paving Way for Expanded Use

Positive Phase 3 Results:
Roche's Gazyva (obinutuzumab) has shown statistically significant and clinically meaningful treatment benefits in patients with active lupus nephritis in the Phase 3 REGENCY study.

Primary Endpoint Met:
The study met its primary endpoint, demonstrating a higher proportion of patients achieving a complete renal response (CRR) at 76 weeks when treated with Gazyva plus standard therapy compared to standard therapy alone.

Secondary Endpoints Achieved:
Two key secondary endpoints were also met, showing improvements in CRR with reduced corticosteroid use and proteinuric response, both critical for enhanced disease control in lupus nephritis.

Safety Profile:
The drug's safety profile was consistent with previous studies, with no new safety signals identified.

Regulatory Submission:
Roche plans to submit the data to health authorities, including the FDA and European Medicines Agency, for potential approval as a new treatment option for lupus nephritis.

Unmet Medical Need:
Lupus nephritis is a serious condition affecting approximately 1.7 million people worldwide, with up to one-third of patients progressing to end-stage kidney disease within 10 years despite current treatments.

Future Studies:
Gazyva is also being investigated in other conditions, including membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus (SLE).