Roche has reported that its Phase III ALLEGORY trial of Gazyva/Gazyvaro (obinutuzumab) in adult patients with systemic lupus erythematosus (SLE) has met its primary goal.
ALLEGORY demonstrated that more subjects achieved a four-point improvement in SLE Responder Index 4 (SRI-4) after 52 weeks compared to those receiving standard therapy alone.
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The double-blind, randomised, multi-centre and placebo-controlled trial is aimed at evaluating the safety and efficacy of the therapy against the standard therapy in adult SLE patients on standard treatments.
All key secondary goals of the study were also achieved alongside the primary outcome.
These included improved responses on the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) response, ongoing control of corticosteroid use between weeks 40 and 52, sustained SRI-4 response in the same timeframe.
Other endpoints included a six-point improvement in SLE disease activity (SRI-6) at 52 weeks, and time to initial disease flare for this period according to the British Isles Lupus Assessment Group (BILAG) index criteria.
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By GlobalDataNo new safety issues were found during the trial, with the therapy’s safety profile remaining consistent with earlier studies.
Around 300 participants were enrolled in the trial and assigned either Gazyva/Gazyvaro or a placebo for a 52-week period, followed by an open-label phase where they received the therapy for up to two years.
The primary goal is the proportion of subjects reaching SRI-4 after 52 weeks.
According to the company, this study is the third positive trial for Gazyva/Gazyvaro for treating immune-mediated conditions, following the trials with lupus nephritis (REGENCY) and idiopathic nephrotic syndrome (INShore).
Roche global product development head and chief medical officer Levi Garraway said: “These pivotal results are unprecedented in demonstrating that by effectively controlling disease activity, Gazyva/Gazyvaro may delay or prevent further organ damage in people with SLE.”
The humanised monoclonal antibody Gazyva/Gazyvaro secured approval for lupus nephritis treatment in adults in the US when used alongside standard treatments.
It also secured approval in 100 nations for several types of haematological cancers.
