Genentech: Positive Topline Results for Phase 2 Lupus Study

• NOBILITY showed that Gazyva helped more patients achieve a complete renal response when added to standard of care
• The Phase II study met both primary and key secondary endpoints
• There are currently no FDA-approved therapies for lupus nephritis

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results for NOBILITY, a Phase II clinical trial investigating the safety and efficacy of Gazyva^® (obinutuzumab) for adults with proliferative lupus nephritis. The study met its primary endpoint, showing Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year. In addition, Gazyva met key secondary endpoints showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo.

“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,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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.”

Lupus nephritis is a severe and potentially life-threatening manifestation of systemic lupus erythematosus (SLE) resulting from inflammation of the kidneys, with proliferative lupus nephritis being the most severe form and associated with the highest risk of end-stage renal disease and death.^1,2 In addition to meeting the primary endpoint, the study’s key secondary endpoint, defined as achievement of overall renal response (complete or partial renal response) at one year, was also met. No new safety signals were observed with Gazyva in the study at the time of this analysis. The full results from the study will be presented at a future medical meeting.

https://www.marketscreener.com/ROCHE-HOLDING-LTD-9364975/news/Genentech-s-Gazyva-Obinutuzumab-Delivers-Positive-Topline-Results-for-Phase-II-Lupus-Nephritis-S-28735645/