Gazyva Combo Helps Lupus Nephritis Patients Achieve Response, Trial Data Show

Gazyva (obinutuzumab) in combination with standard-of-care agents significantly increases the percentage of patients with proliferative lupus nephritis achieving complete or partial renal response, top-line data from a Phase 2 trial show.

Gazyva is a monoclonal antibody that has been designed to bind CD20, a protein found on the surface of certain types of B cells, including malignant chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) cells, destroying them. In the U.S., Gazyva is part of a collaboration between Genentech, a subsidiary of Roche, and Biogen.

Its effects, in combination with other agents, are being tested in patients with various types of blood cancers. However, its mechanism of action also suggests Gazyva may be useful to prevent excessive inflammation associated with several autoimmune diseases, including lupus.

The safety and efficacy of Gazyva in combination with standard-of-care agents — mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids — for the treatment of adult patients with proliferative lupus nephritis are currently being assessed in the NOBILITY Phase 2 trial (NCT02550652).

The trial enrolled 126 patients who were randomly assigned to receive infusions of Gazyva, or a placebo, in combination with MMF/MPA and corticosteroids on days 1, 15, 168, and 182.

The trial’s primary endpoint was to assess whether Gazyva in combination with standard-of-care treatment increased the percentage of patients achieving complete renal responses at week 52, compared to a placebo plus the standard treatment regimen. Secondary endpoints included assessing patients’ overall response rates at week 52, as well as the levels of markers of disease activity.

Now, Roche has announced the first top-line data of the study, revealing that NOBILITY met its primary endpoint, as well as key secondary endpoints:

• A higher percentage of patients receiving Gazyva in combination with the standard treatment regimen achieved complete renal responses at week 52, compared to those treated with a placebo plus the standard treatment;
• Gazyva in combination with standard-of-care agents increased the proportion of patients achieving overall responses (complete or partial renal responses) at week 52, compared to those treated with standard-of-care agents alone;
• No new safety concerns were found among patients treated with Gazyva over the course of the study.

“There are no FDA-approved treatments for lupus nephritis, a potentially life-threatening condition in which patients are at high risk for progressing to end-stage renal disease or death,” Sandra Horning, MD, chief medical officer and head of global product development, said in a press release.

“We have been investigating a possible treatment for lupus nephritis for more than a decade and have integrated key learnings from that experience in how we study the condition. We are encouraged by the NOBILITY results, which showed a statistically significant difference in achievement of complete renal response, overall renal response, and other measures of disease activity, and support the potential for a new treatment option for people living with lupus nephritis.”

Roche is planning to present the trial’s full data at an upcoming medical meeting.