- FDA accepted Genentech's sBLA for Gazyva (obinutuzumab), an anti‑CD20, with an FDA decision expected by December 2026.
- Phase III ALLEGORY (~300 patients, randomized 1:1) met its primary endpoint: SRI‑4 at 52 weeks 76.7% (Gazyva) vs 53.5% (placebo), adjusted difference 23.1% (95% CI 12.5–33.6, p<0.001).
- Key secondary outcomes: DORIS remission 33.8% vs 13.8% (adj diff 19.9%), LLDAS 57.6% vs 25.0% (adj diff 32.6%), and fewer flares (BILAG HR 0.58, p=0.002).
- Safety was consistent with Gazyva's known profile with no new signals; Gazyva is already approved for lupus nephritis in the US and EU and ALLEGORY data have been used for an EMA filing.
Regulatory filing and timeline
FDA accepted Genentech's supplemental BLA for Gazyva (obinutuzumab) for systemic lupus erythematosus (SLE) based on Phase III ALLEGORY; an FDA decision is expected by December 2026. Gazyva is already approved for lupus nephritis in the US and EU.
ALLEGORY design
ALLEGORY (NCT04963296) was a randomized, double-blind, placebo-controlled Phase III trial of ~300 adults with SLE, randomized 1:1 to Gazyva plus standard therapy or placebo plus standard therapy for 52 weeks, with an open-label extension to 104 weeks; primary endpoint was SRI‑4 at week 52.
Key efficacy results
SRI‑4 responder rates at 52 weeks were 76.7% (Gazyva) vs 53.5% (placebo), adjusted difference 23.1% (95% CI 12.5–33.6, p<0.001). Secondary outcomes included higher DORIS remission (33.8% vs 13.8%, adj diff 19.9%), greater LLDAS (57.6% vs 25.0%, adj diff 32.6%), sustained glucocorticoid reduction to ≤7.5 mg/day (weeks 40–52), and fewer flares by BILAG (HR 0.58, p=0.002); median time to first flare was not estimable.
Safety and development context
Safety was consistent with Gazyva's established profile with no new signals; ALLEGORY data have been used for an EMA filing and add to other positive Phase III programs for obinutuzumab in immune-mediated diseases including REGENCY, INShore and MAJESTY; Gazyva is an anti‑CD20 Type II glycoengineered monoclonal antibody that induces direct B‑cell death and increased ADCC.
