Genentech reports ALLEGORY study meets primary endpoint, secondary endpoints

Genentech, a member of Roche (RHHBY), announced statistically significant and clinically meaningful results from the Phase III ALLEGORY study of Gazyva in adults with systemic lupus erythematosus on standard therapy. The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 at one year with Gazyva versus standard therapy. All key secondary endpoints were also met. No new safety signals were identified, and safety was in line with the well-characterized profile of Gazyva. All key secondary endpoints were met, with results showing statistically significant and clinically meaningful benefits with Gazyva versus standard therapy including British Isles Lupus Assessment Group based Composite Lupus Assessment response at week 52, sustained corticosteroid control from week 40 to 52, sustained SRI-4 from week 40 to 52, a six-point improvement in SLE disease activity score at 52 weeks, and time to first flare over 52 weeks as defined by the British Isles Lupus Assessment Group index.