Roche subsidiary Genentech has announced positive topline results for NOBILITY, a Phase II trial of Gazyva (obinutuzumab) for adults with proliferative lupus nephritis, a severe and potentially life-threatening manifestation of systemic lupus erythematosus (SLE).
In combination with standard of care, the therapy showed enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.
The therapy also met key secondary endpoints, showing improved overall renal responses and serologic markers of disease activity, as compared to placebo.
There are no FDA-approved treatments for lupus nephritis. Chief medical officer Sandra Horning said the results “support the potential for a new treatment option for people living with lupus nephritis.”
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