The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to obinutuzumab (Genentech), a CD20-directed cytolytic antibody, for the treatment of adults with lupus nephritis.
The designation was based on data from the phase 2 NOBILITY study that compared the efficacy and safety of obinutuzumab, in combination with mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids, vs placebo plus MMF/MPA and corticosteroids, in patients with proliferative lupus nephritis (N=126). Patients were randomized to receive either obinutuzumab or placebo infusions on days 1, 15, 168, and 182. The primary end point was the proportion of patients who achieved a protocol-defined complete renal response at 52 weeks.
Results showed that the study met its primary end point, with a greater percentage of obinutuzumab-treated patients achieving complete renal response compared with standard of care alone. Additionally, obinutuzumab met key secondary end points, including improved overall renal responses and serologic markers of disease activity, compared with placebo. The study revealed no new safety signals with obinutuzumab.
Full detailed results from the study will be presented at a future medical meeting.
“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We are committed to developing [obinutuzumab] as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase 3 trial next year.”
Obinutuzumab (Gazyva) is already indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia, in combination with chlorambucil; for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen, in combination with bendamustine followed by obinutuzumab monotherapy; and for the treatment of previously untreated stage II bulky, III or IV follicular lymphoma in patients achieving at least a partial remission, in combination with chemotherapy followed by obinutuzumab monotherapy.
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