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Genentech's Gazyva Meets Primary Endpoint In Phase III Systemic Lupus Erythematosus Study

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Genentech, a unit of Roche Holding AG (RHHBY), on Monday reported positive top-line results from its Phase III ALLEGORY study evaluating Gazyva in adults with systemic lupus erythematosus (SLE) receiving standard therapy.

The study met its primary endpoint showing a higher proportion of patients achieving at least four-point improvement in the SLE Responder Index 4 (SRI-4) at 52 weeks compared with standard therapy alone.

SRI is a tool used to assess changes in disease severity, symptoms, and physical condition to determine treatment effectiveness in controlling disease activity.

No new safety signals were identified, and safety profile was in line with the established clinical experience for Gazyva.

Gazyva is also being investigated in children and adolescents with lupus nephritis, as well as adults with membranous nephropathy.

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