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Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

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  • Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome
  • Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in 2EPs, incl. overall RFS, median time to relapse or death, cumulative corticosteroid dose reduction, & fewer relapses by 52wks; Other 2EPs showed no significant difference
  • Gazyva is being studied in membranous nephropathy, lupus nephritis, rare immune-mediated kidney diseases, and systemic lupus erythematosus, with potential EC approval for lupus nephritis expected in the future

Ref: Roche | Image: Roche | Press Release

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