Glimmers of Hope in MS as Genentech, Sanofi and Biogen Present at ECTRIMS
At the virtual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting this week, multiple companies are presenting data for ongoing studies of therapies for multiple sclerosis, a disabling disease of the central nervous system that affects more than one million people in the United States. BioSpace takes a look at some of the data.
Genentech released new long-term data from the Phase III OPERA I and OPERA II studies that demonstrated the safety and efficacy of Ocrevus as a treatment for MS. The data showed that the use of Ocrevus led to a 35% reduction in risk of needing a walking aid in relapsing multiple sclerosis (RMS) patients after 7.5 years of use. This was compared to those who switched from treatment with interferon beta-1a to Ocrevus after a 96-week double-blind period. Data also showed that switching from interferon beta-1a to Ocrevus at the start of the open-label extension (OLE) period was linked with a rapid and robust reduction in annualized relapse rate, which was maintained through the 5.5-year OLE period.
Additionally, data from the Phase III ORATORIO OLE study showed that early use of Ocrevus in patients with primary progressive is favorable. Eight-year data showed that treating Ocrevus demonstrated a 29% reduction of 48-week confirmed disability progression in MS after eight years. That’s in comparison to trial patients who switched to Ocrevus from placebo after the double-blind period of at least 120 weeks. Many people with PPMS eventually transition into a wheelchair; therefore, maintaining the ability to use their hands and arms, which is essential for these patients.
The company also released data from shorter infusion studies of Ocrevus in minority patients that showed reactions were similar in Black, African-American, Hispanic, and Latino patients. Genentech stated that these patient populations “may experience greater disease severity and faster progression, yet are vastly underrepresented in most clinical trials.” The company noted that a shorter infusion time might help reduce the burden on these patient populations and increase their access to treatment.
Boston-based Biogen also presented data at ECTRIMS showcasing the benefit of its interferon treatment for MS patients who have been vaccinated against COVID-19. Biogen showed that 100% of MS patients treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination. Additionally, the data from the analysis revealed that 40% of these patients who were treated with anti-CD20 and S1P disease-modifying therapies (DMT) mount an antibody response to the COVID-19 vaccine.
Approximately 92% of patients analyzed in the study received an mRNA vaccine. Immune response was measured using immunoglobulin G (IgG) assays. Data for the study was gained from blood samples provided by the MS PATHS network, with preliminary results suggesting that anti-CD20 and sphingosine 1-phosphate (S1P) therapies may reduce the antibody response to COVID-19 vaccination.
Other classes of MS drugs were also assessed in the study, including the company’s own therapies, which showed the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy.
Biogen Chief Medical Officer Maha Radhakrishnan acknowledged the analysis as it provides essential information for MS patients during the global pandemic. She also noted that the company wanted MS patients and caregivers to have the information at hand in order to understand levels of protection against the virus.
“Leveraging the unique MS PATHS network, we were able to quickly generate data on the impact of the different MS DMTs on COVID-19 vaccine antibody responses. This is part of a comprehensive plan to understand B and T cell activation in the context of people with MS on DMTs being vaccinated for COVID-19 and will add to efforts by researchers to gather these important data,” Radhakrishnan said in a statement.
Sanofi also showcased data for its experimental MS drug, tolebrutinib, an oral brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor. Data from a Phase IIb long-term extension study in RMS showed that following 48 weeks of treatment, tolebrutinib reduced multiple sclerosis disease activity as measured by MRI.
Trial results showed favorable safety and efficacy for tolebrutinib. At the one-year mark, nearly all patients remained enrolled in the study. Patients who were treated with 60mg of tolebrutinib experienced low annualized relapse rates over the 48 week period. The majority of the patients, 89.5%, were relapse free during this time period.
Tolebrutinib is being assessed in multiple Phase III clinical trials for the relapsing forms of MS, as well as non-relapsing secondary progressive MS and primary progressive MS. Erik Wallstrom, therapeutic area head of Sanofi’s neurology department, noted that the studies are critical to understanding the ability of a brain-penetrant therapy to slow disability accumulation in MS patients. Tolebrutinib has the potential to “bring new hope to people suffering from difficult-to-treat MS,” he said in a statement.