Genentech's blood cancer drug Gazyva moves toward more indications in immunology

Genentech plans to expand the label for its CD20-targeting antibody Gazyva following positive late-stage data in an autoimmune disease that impacts the kidneys.

In the Phase 3 REGENCY study, a higher proportion of patients with lupus nephritis treated with Gazyva and standard therapy achieved a complete renal response at 76 weeks compared to those treated with just standard therapy. The standard therapies used in the trial were the immunosuppressant mycophenolate mofetil and the corticosteroid called glucocorticoid.

The company said that the data are being shared with the FDA and other health regulatory agencies, with a goal to make Gazyva available “as soon as possible.”

According to Genentech, lupus nephritis is a manifestation of systemic lupus erythematosus, an autoimmune disease. Lupus nephritis impacts about 1.7 million people worldwide and gets worse over time, with up to a third of people progressing to end-stage kidney disease within a decade. The drug scored breakthrough designation from the FDA in 2019 in the indication.

Levi Garraway

Genentech CMO and head of global product development Levi Garraway said in a statement that the drug achieved a “robust” complete renal response.

“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,” Garraway added.

The trial also showed statistically significant and clinically meaningful results in secondary endpoints at 76 weeks, including the proportion of patients achieving complete renal response with a successful reduction of corticosteroid use, and an improvement in proteinuric response. However, other secondary endpoints weren’t “statistically significant, but numerically greater responses were observed for Gazyva in several endpoints,” the company said.

Gazyva, which is already approved to treat types of lymphoma, is being investigated in other areas, including in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus.

In Roche’s half-year report, Gazyva pulled in about $523.7 million (445 million CHF), a 15% increase from the same time last year.