Positive Phase III results for Roche’s Gazyva/Gazyvaro in lupus

Swiss pharma giant Roche (ROG: SIX) has announced positive top-line results from the Phase III REGENCY study of Gazyva/Gazyvaro (obinutuzumab) in people with active lupus nephritis.

The company noted that, in the study, a higher proportion of people treated with Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) at 76 weeks compared to those treated with standard therapy alone. Safety was in line with the well-characterized profile of Gazyva/Gazyvaro. No new safety signals were identified, its said.

“Gazyva/Gazyvaro achieved a robust complete renal response rate in lupus nephritis, which is associated with long-term preservation of kidney function and delay or prevention of end-stage kidney disease,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “Since dialysis or transplants are often required for patients with advanced kidney disease, these findings could represent an important step forward for people living with this devastating disease.”