Roche has new positive data for its IL-6 targeting antibody satralizumab for neuromyelitis optica spectrum disorder (NMOSD), with regulatory decisions expected in 2020 as it prepares to go head-to-head with Alexion’s Soliris.
NMOSD is an autoimmune disease that affects the central nervous system, and is characterised by progressive damage to neurons during relapses that can lead to blindness and paralysis.
The results from Roche’s pivotal phase 3 study of satralizumab, SakuraSky, were published in the New England Journal of Medicine (NEJM). The detailed results showed that satralizumab reduced the risk of patients experiencing protocol-defined relapse (PDR) compared to the placebo arm.
Patients treated with satralizumab also remained relapse-free for longer than those in the placebo group – 89%, 78% and 74% of patients treated with the IL-6 antibody in combination with baseline therapy had not experienced relapse at weeks 48, 96 and 144 respectively.
This is an impressive benefit over the placebo arm, with figures of 66%, 59% and 49% in comparison at the same time points.
In addition to the main patient population that was studied, Roche scored positive results from a specific subgroups of aquaporin-4 (AQP4-IgG) seropositive and seronegative patients.
This group reflects a real-world population of adolescents and adults with NMOSD who tend to experience a more severe disease course.
Out of the AQP4-IgG seropositive subgroup analysis, three of 27 patients (11%) on the treatment arm experienced a PDR compared to 12 of 28 patients (43%) in the placebo arm.
In the AQP4-IgG seronegative subgroup, five of 14 patients (36%) treated with satralizumab experienced a PDR compared to six of 14 patients (43%) receiving the placebo treatment.
“Satralizumab has shown robust efficacy sustained for 144 weeks across a broad patient population in two phase 3 studies, whether given as a monotherapy or in combination with baseline therapy. We’re encouraged that satralizumab may soon provide a new treatment option for people living with NMOSD,” said Levi Garraway (pictured left), Roche’s chief medical officer and head of global product development.
The first and only currently approved treatment in the US for NMOSD is Alexion’s complement C5 inhibitor Soliris (eculizumab) which was approved by the FDA in June.
It was approved to treated NMOSD in adult patients who are AQP4 antibody positive. Alexion also received European Commission approval for the extended use of Soliris in the same indication in August.
Roche is looking to encroach into the market by next year, and has filed the drug for approval with both the FDA in the US and the European Medicines Agency.
However, both Roche and Alexion could face competition from biosimilars, as Amgen recently filed a patent infringement action against Soliris.
Amgen’s challenge comes shortly after Alexion secured an extension to its patent protection for Soliris until 2027 – Alexion’s main patent on the drug expires in the US in 2021.
Amgen has interest in the therapy area due to a biosimilar version of Soliris that it has advanced into clinical testing,