Study Results
The Phase III ALLEGORY study demonstrated that Gazyva met its primary and all key secondary endpoints in treating systemic lupus erythematosus (SLE). The study showed a significant improvement in the SLE Responder Index 4 (SRI-4) at 52 weeks compared to standard therapy, with no new safety concerns identified.
Potential Impact
If approved, Gazyva would be the first anti-CD20 therapy for SLE, directly targeting B cells, which are crucial in driving inflammation and disease activity. This could establish Gazyva as a new standard of care for SLE, potentially benefiting up to 3.4 million people worldwide.
Additional Findings
All key secondary endpoints were achieved, including improvements in the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) response, sustained corticosteroid control, and SRI-6 scores. The study also noted a delay in the time to first flare over 52 weeks.
Next Steps
Data from the study will be presented at an upcoming medical meeting and submitted to health authorities, including the US FDA and the European Medicines Agency, for potential approval. Gazyva is also being investigated for other immune-mediated diseases, such as lupus nephritis and idiopathic nephrotic syndrome.
