New 4-Year Data Show Genentech’s Enspryng Significantly Reduces Debilitating Relapses in People with NMOSD
Genentech announced new longer-term efficacy and safety data for Enspryng (satralizumab-mwge). The data show Enspryng has a favorable benefit-risk profile and is effective in reducing relapses over 4 years of treatment in people with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD, a rare debilitating disease that affects the central nervous system. Efficacy and safety results from the open-label extension (OLE) periods of the SAkuraStar and SAkuraSky studies, in addition to the design of SAkuraBONSAI, a new study in people with AQP4-IgG seropositive NMOSD who are treatment-naïve, or where prior rituximab (or biosimilar) treatment has failed, will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
“The positive longer-term efficacy and safety results for Enspryng are important for physicians as they consider Enspryng as a treatment option for their patients,” said Dr. Ingo Kleiter, Ruhr University Bochum, Germany. “Just one NMOSD relapse can lead to lifelong disability. An early accurate diagnosis followed by an effective treatment is vital to conserving the quality of life of people with this chronic disease.”
The pivotal SAkuraStar and SAkuraSky 4 year OLE data found that 73% and 71% of people with AQP4-IgG seropositive NMOSD treated with Enspryng remained relapse-free after 192 weeks (3.7 years), respectively, and 90% and 91% remained free from severe relapse.[1] These results demonstrate that the robust efficacy observed in the studies’ double-blind periods is sustained longer-term for Enspryng as both a monotherapy and in combination with immunosuppressive therapy.
The data also demonstrate a favorable safety and tolerability profile for Enspryng in the overall Enspryng treatment period of up to 7 years, comparable to the double-blind treatment periods in both SAkuraStar and SAkuraSky studies. Rates of adverse events and serious adverse events during the overall treatment periods were consistent with Enspryng and placebo in the double-blind periods. The most common adverse reactions observed were: headache, arthralgia, white blood cell count decrease, hyperlipidemia, and injection-related reactions. No new safety signals were observed.
“We are pleased that these longer-term data further reinforce the previously observed efficacy and safety of Enspryng, which was specifically designed for this lifelong, chronic disease by targeting the IL-6 pathway to reduce the frequency of relapses,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Enspryng is the only treatment for NMOSD that can be administered subcutaneously at home and has now been approved in over 50 countries. The totality of data, combined with the experience of people treated and their physicians, underscores the importance of this treatment option.”
Genentech is also initiating SAkuraBONSAI, a multicenter, phase 3b, international study, to further evaluate disease activity and progression using comprehensive imaging, biomarker and clinical assessments in NMOSD populations where further research is warranted. People with AQP4-IgG seropositive NMOSD, who are treatment-naïve or where prior rituximab (or biosimilar) treatment has failed, will be administered Enspryng monotherapy for 2 years and evaluated using clinical measures such as magnetic resonance imaging, optical coherence tomography and biomarkers of blood and cerebrospinal fluid.
Enspryng is the first and only NMOSD treatment administered subcutaneously every four weeks for adults living with AQP4-IgG seropositive NMOSD, allowing for home-dosing and increasing flexibility and convenience for people with NMOSD. Enspryng is approved in 58 countries, including the United States, Canada, Japan, South Korea and the European Union and applications are under review in additional countries.
About SAkuraStar and SAkuraSky in NMOSD
Enspryng has been investigated in two pivotal phase 3 studies in neuromyelitis optica spectrum disorder (NMOSD), with the primary endpoint of both studies being time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period. In the open-label extension (OLE) periods of the SAkura studies, PDRs were determined by the investigator.
The phase 3 SAkuraStar study evaluated the efficacy and safety of Enspryng monotherapy administered to adults with NMOSD. In the anti-aquaporin-4 antibody (AQP4-IgG) seropositive subgroup, 83% treated with Enspryng remained relapse-free at 48 weeks, compared with 55% of those treated with placebo. At 96 weeks, 77% of those treated with Enspryng remained relapse-free, compared with 41% with placebo.
The phase 3 SAkuraSky study evaluated the efficacy and safety of Enspryng in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. Overall, 92% of AQP4-IgG seropositive participants receiving Enspryng in combination with immunosuppressive therapy remained relapse-free at 48 and 96 weeks, compared with 60% and 53% with placebo, respectively.
Enspryng showed a favorable safety and tolerability profile in the phase 3 studies. The most common adverse reactions observed were: headache, arthralgia, white blood cell count decrease, hyperlipidemia and injection-related reactions.