Roche’s Gazyva Shows Promising Results in Phase III Lupus Nephritis Trial
Gazyva (obinutuzumab) plus standard therapy achieved a 46.4% complete renal response (CRR) rate at 76 weeks compared to 33.1% with standard therapy alone in lupus nephritis patients46.
The Phase III REGENCY trial enrolled 271 patients with active lupus nephritis, randomized to receive either Gazyva or placebo with standard treatments36.
Gazyva is the only anti-CD20 monoclonal antibody to demonstrate CRR benefit in a randomized Phase III study for lupus nephritis46.
The treatment showed consistent benefits across patient subgroups and improvements in complement levels and disease activity markers4.
Gazyva's safety profile was consistent with its known profile in hematology-oncology indications, with no new safety signals identified16.
Secondary endpoints showed higher proteinuric response rates and better CRR with successful corticosteroid reduction in the Gazyva group46.
Lupus nephritis disproportionately affects younger women, particularly women of color, and can lead to end-stage kidney disease6.
Gazyva received FDA Breakthrough Therapy Designation for lupus nephritis in 2019 based on Phase II NOBILITY study data14.
Results from the REGENCY trial were published in the New England Journal of Medicine and presented at the World Congress of Nephrology 202546.
Roche is sharing the data with health authorities, including the FDA and European Medicines Agency, for potential approval in this new indication46.
Sources:
1. https://www.roche.com/media/releases/med-cor-2024-09-26
3. https://endpts.com/roche-heads-to-fda-with-gazyva-results-in-a-form-of-lupus/
4. https://www.stocktitan.net/news/RHHBY/new-england-journal-of-medicine-publishes-new-data-for-roche-s-i5nabqj1oa1h.html