(RTTNews) - Roche (RHHBY) said that the phase II NOBILITY study met the primary endpoint with Gazyva, in combination with standard of care. The study investigated the safety and efficacy of Gazyva or obinutuzumab for adults with proliferative lupus nephritis.
Lupus nephritis is a severe and potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys, with proliferative lupus nephritis being the most severe form and associated with high-risk of end-stage renal disease and death.
The phase II NOBILITY showed 40% of patients treated with Gazyva plus standard of care achieved complete renal response at Week 76, compared to 18% of patients treated with placebo plus standard of care.
Gazyva additionally met key secondary efficacy endpoints showing improved overall renal response and serologic markers of disease activity as compared to placebo. The company said it plans to initiate enrollment in a phase III programme.
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