Genentech has announced positive results from its phase 3 REGENCY trial evaluating obinutuzumab (Gazyva) in combination with standard therapy for the treatment of lupus nephritis. The study met its primary endpoint, demonstrating a statistically significant improvement in complete renal response among participants.
The REGENCY study (NCT04221477) assessed the efficacy and safety of obinutuzumab in patients with lupus nephritis, a severe complication of systemic lupus erythematosus (SLE) that affects the kidneys. Lupus nephritis can lead to kidney failure and other serious health problems if left untreated.
Trial Design and Results
The phase 3 trial enrolled patients with active lupus nephritis. Participants were randomized to receive either obinutuzumab plus standard therapy or standard therapy alone. The primary endpoint was the percentage of participants achieving a complete renal response at a specified time point.
Genentech reported that the obinutuzumab arm demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint compared to the standard therapy arm. The company is preparing the data for publication in a peer-reviewed journal and presentation at a future medical conference.
Significance of Findings
Lupus nephritis is a challenging condition to treat, and new therapies are needed to improve outcomes for patients. Obinutuzumab, a monoclonal antibody targeting CD20-positive B cells, has shown promise in previous studies for SLE. The positive results from the REGENCY trial suggest that obinutuzumab could become an important treatment option for lupus nephritis.
Further details regarding the specific data and statistical significance will be available upon publication or presentation of the full study results.
