Roche’s Gazyva shows strong Phase III results in lupus study

Swiss pharma major Roche (ROG: SIX) has reported positive Phase III data for Gazyva (obinutuzumab) in systemic lupus erythematosus. The ALLEGORY study met its primary and all key secondary endpoints, showing that patients treated with Gazyva achieved significantly greater reductions in disease activity versus standard therapy.

The study’s main measure, a four-point improvement on the lupus activity index at one year, was reached by 52% of patients receiving Gazyva. All secondary goals, including steroid control and delayed flares, were also met. No new safety signals emerged, and tolerability was consistent with prior studies in lupus nephritis.

Dr Levi Garraway, Roche’s chief medical officer, said the results demonstrated Gazyva’s potential to prevent irreversible organ damage by controlling inflammation. Roche plans to share the findings with global regulators soon, with the aim of securing approval for the first anti-CD20 therapy to directly target B cells in lupus.