Genentech announces INShore study of Gazyva meets primary endpoint

Genentech, a member of Roche (RHHBY), announced statistically significant and clinically meaningful results from the Phase III INShore study of Gazyva in children and young adults with idiopathic nephrotic syndrome. The study met its primary endpoint, with more people achieving sustained complete remission at one year with Gazyva compared with mycophenolate mofetil. Sustained complete remission was defined by the absence of relapses during the study together with a low amount of protein in the urine at week 52. Certain important key secondary endpoints were also met. No new safety signals were identified and safety was in line with the well-characterized profile of Gazyva in adults. Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva with an increase in those with overall relapse-free survival, median time to relapse or death, reduction in cumulative corticosteroid dose from baseline to week 52, and fewer relapses from baseline to week 52, all compared with MMF. Other key secondary endpoints showed no significant difference with Gazyva versus MMF. Data will be presented at an upcoming medical meeting and shared with health authorities, including the FDA and the European Medicines Agency. INShore data add to a growing body of evidence, including the Phase III REGENCY study in lupus nephritis, that shows targeting disease-causing B cells with Gazyva may help address disease activity across a spectrum of immune-mediated kidney and kidney-related diseases. In October, Gazyva was approved in the U.S. for the treatment of adults with active lupus nephritis who are receiving standard therapy, based on data from the Phase III REGENCY and Phase II NOBILITY studies. In addition to idiopathic nephrotic syndrome, Gazyva is being investigated in membranous nephropathy, lupus nephritis, rare immune-mediated kidney diseases and systemic lupus erythematosus, an autoimmune disease that can lead to lupus nephritis.