While Roche’s Gazyva has been on the market for a dozen years and has won four approvals from the FDA, it is making a late push to gain a nod in what would be its most important indication—lupus nephritis.
In September, Roche revealed success in the phase 3 Regency trial in lupus nephritis. Now the numbers are out, showing that 46.4% of patients who received Gazyva plus a standard therapy achieved complete renal response compared to 33.1% of patients on standard care alone, which consists of the immunosuppressive agent mycophenolate mofetil and glucocorticoids.
Patients were evaluated at 76 weeks after receiving twice annual infusions of Gazyva.
The primary endpoint results, which were characterized as statistically significant and clinically meaningful, were accompanied by improvements in complement levels and other biomarkers of disease activity and inflammation, Roche said.
It did fall short, however, on secondary responses that looked at patients’ mean change in estimated glomerular filtration rates, death or renal-related events and overall renal responses.
The results were revealed in the New England Journal of Medicine and presented at the World Congress of Nephrology in New Delhi, India.
“The fact that nearly half of lupus nephritis patients achieved a complete renal response, together with clinically meaningful benefits observed consistently across subgroups, indicates superior disease control with Gazyva compared to standard treatment alone,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a release.
Richard Furie, a rheumatologist at Northwell Health, added that it was “gratifying to see that patients who received (Gazyva) were not only more likely to achieve the desired outcome but were able to taper corticosteroids.”
Roche has sent the data to the FDA and the European Medicines Agency (EMA) for regulatory review.
Gazyva was first endorsed by the FDA in 2013 and has so far been cleared to treat various blood cancers. If greenlighted, Gazyva would become the first CD20-directed therapy approved in lupus nephritis. GlobalData projects that a nod could catapult sales of the monoclonal antibody to $1.7 billion by 2030.
A dozen years ago, Roche failed to gain approval for Gazyva predecessor Rituxan in lupus nephritis as it came up short in a phase 3 trial. Despite this, doctors have been using Rituxan off-label based on real-world results.
Lupus nephritis is a potentially life-threatening manifestation of the most common form of the disease lupus erythematosus (SLE) and has no cure. It involves kidney inflammation and primarily affects women, specifically women of color. Of the 1.7 million worldwide who have the disorder, a third will develop end-stage kidney disease within ten years, with dialysis and kidney transplants serving as their only available treatment options, according to Roche.
GSK’s biologic blockbuster Benlysta, which was approved in 2011, is the dominant treatment for SLE. AstraZeneca’s biologic Saphnelo was approved in 2021 in the indication.