13 November 2019 - - US-based biotechnology company Genentech has received data from the Phase II NOBILITY study, investigating the safety and efficacy of Gazyva (obinutuzumab) for adults with proliferative lupus nephritis, the company said.
Genentech is a member of the Roche Group (SIX: RO) (OTCQX: RHHBY).
The study met the primary endpoint with Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrating superiority compared to placebo plus standard of care.
Patients treated with Gazyva showed increasing rates of complete renal response from week 52 to week 76, with 40% of patients in the Gazyva group achieving CRR, compared to 18% of patients in the placebo group at week 76 (p=0.007).
Gazyva additionally met key secondary efficacy endpoints showing improved overall renal response (complete or partial renal responses) and serologic markers of disease activity as compared to placebo. No new safety signals were observed with Gazyva in the study at the time of this analysis.
Through week 76, serious adverse events (24% vs. 29% in placebo group) and serious infections (6% vs.18% in placebo group) were not increased with Gazyva.
These data will be presented at the 2019 American College of Rheumatology annual meeting in Atlanta, Georgia, on November 10, 2019 (Abstract 939).
Lupus nephritis is a severe and potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys, with proliferative lupus nephritis being the most severe form and associated with high-risk of end-stage renal disease and death. In September 2019, the US Food and Drug Administration granted Breakthrough Therapy Designation to Gazyva for adults with lupus nephritis based on the Phase II NOBILITY study data.
Genentech will initiate a Phase III study for Gazyva in lupus nephritis in 2020.
Phase II data from the NOBILITY study was also presented as a late-breaking oral presentation at the American Society of Nephrology's Kidney Week 2019 in Washington, DC, on November 8, 2019 (Abstract FR-OR136).
The Phase II, randomised, double-blind, placebo-controlled, multi-center study, NOBILITY (NCT02550652), compared the safety and efficacy of Gazyva, combined with mycophenolate mofetil or mycophenolic acid and corticosteroids, to placebo, combined with MMF or MPA and corticosteroids, in adult patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis.
The study enrolled 125 people who were randomized to receive Gazyva or placebo infusions on days 1, 15, 168, and 182.
The primary endpoint was the proportion of participants who achieved a protocol-defined complete renal response at 52 weeks. Key secondary endpoints included overall renal responses (complete or partial renal response) and serologic markers of disease activity, as compared to placebo.
Patients were followed in a blinded fashion through week 104, and patients with persistent B-cell depletion are being followed for safety and continued B-cell measurements.
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system.
Gazyva is part of a collaboration between Genentech and Biogen. Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.