Roche touts phase 2 Gazyva data in lupus patients with a potentially fatal kidney complication

Roche cancer drug Gazyva met its endpoint in a phase 2 lupus nephritis study, the company said. (Roche)

One brand-new FDA approval and one trial win for its blood cancer drug Gazyva added up to a double dose of good news for Roche Monday.

The Swiss drugmaker snapped up a combo approval for lymphoma drug Polivy, then touted Gazyva trial results in a completely different field: lupus nephritis, a potentially fatal complication of the autoimmune disease systemic lupus erythematosus (SLE).

In a phase 2 study, adding Gazyva to standard lupus nephritis treatment beat that standard of care alone at delivering complete renal responses at one year. The drug also hit key secondary goals.

There are no drugs specifically approved to treat lupus nephritis. The standard of care used in the trial combined one of two immunosuppressant drugs approved for organ transplant patients—CellCept or Myfortic—with corticosteroids and placebo. Roche plans to present the full data at an upcoming meeting. 

SLE, in which a patient’s immune system attacks healthy cells and organs, makes up approximately 70% of the 1.5 million lupus cases in the U.S., Roche says. The disease mostly affects women, particularly young women of color.

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RELATED: The top 15 best-selling cancer drugs in 2022 | Gazyva

After initially posting slow growth following a 2013 approval, Roche's Gazyva has picked up steam lately; last year, it grew sales 40% to about $393 million. The med carries FDA approvals in chronic lymphocytic leukemia and follicular lymphoma.

Aside from blood cancers, Roche’s Genentech is testing the med in lupus nephritis and end-stage renal disease, its online pipeline shows. Analysts once predicted the drug would generate more than $3 billion by 2022.

RELATED: Roche snags first-in-class FDA nod for lymphoma drug Polivy 

Roche is touting the Gazyva data as the biosimilar threat to cancer blockbusters Rituxan, Herceptin and Avastin nears. The company has said it expects U.S. competition this year for the trio of drugs that generated $10 billion in U.S. sales last year.

To pick up the slack, Roche is working to bolster new launches—including multiple sclerosis drug Ocrevus and hemophilia med Hemlibra.

Another launch just joined the fray, too. The FDA approved first-in-class drug Polivy in combo with Rituxan and the chemotherapy bendamustine to treat diffuse large B-cell lymphoma patients who've failed on at least two prior treatments. Analysts believe the new drug could grow to blockbuster-level sales if it snags enough market share in that indication and wins approval to treat patients earlier in the disease.

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