MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous Nephropathy

MAJESTY, the first global phase 3 study in primary membranous nephropathy (PMN), met its primary endpoint of complete remission at 2 years with obinutuzumab (Gazyva).1

Genentech announced the positive 2-year phase 3 results of obinutuzumab compared to tacrolimus on February 16, 2026, with the potential for the therapeutic to become the first approved treatment for PMN.1

“These results demonstrate that obinutuzumab may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer, and delay or potentially prevent the onset of life-threatening complications,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, in a statement. “If approved, Gazyva would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options.”1

In patients with PMN, approximately 30 to 40% with severe proteinuria progress to end-stage renal disease or experience significant, irreversible kidney failure 10 years postdiagnosis. A major driver of adverse clinical outcomes is failure to achieve remission, which has been associated with increased rates of needing replacement renal therapy and death.2

Obinutuzumab is a humanized monoclonal antibody designed with a type II anti-CD20 region for direct B-cell death and a glycoengineered Fc region for increased binding affinity and increased antibody-dependent cellular cytotoxicity. The therapy has already been approved for adults with lupus nephritis and in 100 countries for various types of hematological cancers.1

MAJESTY, the phase 3 randomized, open-label, multicenter study, evaluated the efficacy and safety of obinutuzumab compared to tacrolimus in patients with PMN. The study included 142 participants who were randomized in a 1:1 ratio to receive either obinutuzumab or tacrolimus. The primary endpoint was the percentage of people who achieved complete remission at week 104, or 2 years.1

From the primary results, investigators reported statistically significant and clinically meaningful results with obinutuzumab in achieving complete remission at 2 years. Overall, safety was in line with the previous safety profile of obinutuzumab, with no new safety signals identified.1

Upon analysis of key secondary endpoints, investigators observed statistically significant and clinically meaningful benefits in patients treated with obinutuzumab compared to those treated with tacrolimus in overall remission, complete or partial, at week 104 and complete remission at week 76.1

References

1. Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy, Marking a Significant Milestone in This Autoimmune Disease. BusinessWire. Published February 16, 2026. Accessed February 16, 2026. https://www.businesswire.com/news/home/20260215765811/en/Genentech-Announces-Positive-Phase-III-Results-for-Gazyva-in-Primary-Membranous-Nephropathy-Marking-a-Significant-Milestone-in-This-Autoimmune-Disease

2. Westermann L, Rottmann FA, Hug MJ, et al. Clinical covariates influencing clinical outcomes in primary membranous nephropathy. BMC Nephrology. 2023;24(1). doi:https://doi.org/10.1186/s12882-023-03288-x