Roche’s Gazyva/Gazyvaro recommended for EU approval in SLE

Regulatory recommendation

The EMA’s Committee for Medicinal Products for Human Use recommended Gazyva/Gazyvaro (obinutuzumab) as an add-on treatment for adults with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus (SLE) despite standard therapy. A final European Commission decision is expected in the near future. The FDA has accepted Roche’s supplemental Biologics License Application for SLE.

Phase III results

The recommendation is based on the ALLEGORY study. At week 52, 76.7% of patients receiving obinutuzumab plus standard therapy achieved at least a four-point improvement on the SLE Responder Index (SRI-4), compared with 53.5% receiving placebo plus standard therapy. The adjusted difference was 23.1% (95% CI: 12.5–33.6; p<0.001).

Obinutuzumab also outperformed placebo on key secondary endpoints, including BICLA response, sustained glucocorticoid reduction, sustained SRI-4 response, SRI-6 response and time to first flare. Remission rates were 33.8% versus 13.8%, while 57.6% versus 25.0% of patients achieved Lupus Low Disease Activity State. The safety profile was consistent with the established profile, with no new safety signals identified.

Study and disease context

ALLEGORY was a randomised, double-blind, placebo-controlled phase III trial that enrolled approximately 300 adults with SLE on standard therapy. Participants received obinutuzumab or placebo for up to 52 weeks, followed by an open-label period of up to 104 weeks.

SLE is a chronic autoimmune disease that can affect multiple organ systems and cause recurrent flares and progressive organ damage. Around half of people with SLE develop lupus nephritis within five years of diagnosis.