Phase III SAkuraStar and SAkuraSky trials of Enspryng shows efficacy in neuromyelitis optica spectrum disorder.- Genentech/Roche

Genentech/Roche are presenting new Enspryng (satralizumab-mwge) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system, in addition to longer-term efficacy data supporting the continued effect of Enspryng on reducing the risk of NMOSD relapse, as well as its favorable benefit:risk profile. In a post-hoc analysis of the Enspryng-treated group, the risk of severe relapse was reduced by 79% compared to placebo (5 of 27 [19%] vs. 12 of 34 [35%]), for patients across the double-blind periods of the SAkura studies. Preventing relapses, the most severe of which cause cumulative, irreversible, neurological damage and disability, is the primary goal for NMOSD treatment management. The patients treated with Enspryng were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, p=0.015). A relapse was categorized as severe if it resulted in a change of at least 2 points on the Expanded Disability Status Scale.In a separate pooled analysis, Enspryng reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; p=0.002) compared to those originally in the placebo group. This effect was more pronounced in aquaporin-4 antibody (AQP4-IgG) seropositive patients, who tend to experience a more severe disease course, with 66% reduction in risk of relapse (HR, 0.34; 95% CI, 0.19–0.62; p<0.001) compared to those originally in the placebo group. in the double-blind periods, infection rates were lower in the enspryng-treated group compared to placebo in the sakurastar study (99.8 vs. 162.6 events 100 patient years [py]), whereas infection rates did not differ between groups in the sakurasky study. serious infection rates were comparable between both groups in each of the studies (sakurasky: 2.6 vs. 5.0 events 100py; sakurastar: 5.2 vs. 9.9 events 100py). infection and serious infection rates for enspryng-treated patients in the combined double-blind and ole periods were consistent with those for enspryng-treated patients in the double-blind portion in terms of the nature and rate of adverse events and did not increase over time. these data are being presented at msvirtual2020, the 8th joint americas committee for treatment and research in multiple sclerosis (actrims) - european committee for treatment and research in multiple sclerosis (ectrims) meeting.>