Genentech's Gazyva meets primary goal in late-stage kidney disease trial

Genentech aims to broaden the use of its CD20-targeting antibody, Gazyva, following encouraging Phase 3 trial results in an autoimmune kidney disease. The REGENCY study demonstrated that a higher percentage of lupus nephritis patients treated with Gazyva in combination with standard therapies achieved a complete renal response at 76 weeks compared to those receiving only standard therapies. The standard treatments in the trial included the immunosuppressant mycophenolate mofetil and the corticosteroid glucocorticoid.

The company is sharing the trial data with the FDA and other health authorities, aiming to make Gazyva available to patients as swiftly as possible. Lupus nephritis, a severe manifestation of systemic lupus erythematosus (SLE), affects approximately 1.7 million individuals globally. This condition worsens over time, with up to one-third of sufferers advancing to end-stage kidney disease within ten years. Gazyva received a breakthrough designation from the FDA in 2019 for this indication.

Levi Garraway, Genentech's Chief Medical Officer and head of global product development, highlighted the significant complete renal response achieved by the drug. He remarked that the findings could be a crucial advancement for patients with severe kidney disease, who often need dialysis or transplants.

In addition to the primary endpoint, the trial revealed statistically significant and clinically meaningful results in several secondary endpoints at 76 weeks. These included the proportion of patients achieving complete renal response with reduced corticosteroid use and an improvement in proteinuric response. Nonetheless, some secondary endpoints were not statistically significant, although numerically greater responses were observed for Gazyva.

Gazyva, which is already approved for certain types of lymphoma, is also under investigation for other conditions. These include lupus nephritis in children and adolescents, membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus.

In Roche’s half-year financial report, Gazyva generated approximately $523.7 million (445 million CHF), marking a 15% increase compared to the same period last year.