Roche, Sanofi, and Biogen Unveil Latest Clinical Data for Multiple Sclerosis Therapies at ECTRIMS

Compiled & Translated by | Tom Li, newborn

Multiple sclerosis (MS) is a disabling disease of the central nervous system that affects over one million Americans, and it has also become one of the most active R&D areas for global pharmaceutical companies. At the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress held this week, several companies, including Roche's Genentech, Sanofi, and Biogen, actively shared and presented ongoing research data on their MS therapies.

`Genentech`

At the conference, Genentech presented long-term data from the OPERA I, OPERA II, and OPERA III studies, demonstrating the safety and efficacy of Ocrevus as a treatment for multiple sclerosis. The trial data showed that after 7.5 years of Ocrevus treatment, patients with relapsing multiple sclerosis (RMS) had a 35% lower risk of requiring a walking aid compared with those who switched from interferon beta-1a to Ocrevus following the 96-week double-blind period. The data also indicated that patients who switched from interferon beta-1a to Ocrevus at the start of the open-label extension (OLE) period experienced a rapid and significant reduction in the annualized relapse rate, an effect that was sustained throughout the 5.5-year OLE period.

Furthermore, data from the Phase III ORATORIO OLE study indicate that early treatment with Ocrevus provides clinical benefits in patients with primary progressive multiple sclerosis. Clinical data spanning up to 8 years demonstrate that, compared with trial patients who switched from placebo to Ocrevus following a double-blind period of at least 120 weeks, those who received Ocrevus experienced a 29% reduction in confirmed disability progression at week 48. Given that many patients with this disease subtype eventually become wheelchair-dependent, preserving their ability to use their hands and arms through treatment is of critical importance.

The company also released data from a study evaluating shorter Ocrevus infusion durations in minority patients, which demonstrated comparable efficacy responses among Black, African American, Hispanic, and Latino patients. Genentech stated that these patient populations "may experience more severe disease and faster progression, yet remain significantly underrepresented in most clinical trials." The company noted that the relatively shorter infusion duration of Ocrevus could help reduce the burden on these patient groups and improve their access to treatment.

Biogen

Boston-based Biogen also presented trial data at the ECTRIMS Congress, demonstrating the benefits of its interferon therapy for multiple sclerosis patients who have received COVID-19 vaccination. The trial data indicated that following COVID-19 vaccination, 100% of MS patients treated with natalizumab, interferon, or fumarates mounted an antibody response. Furthermore, analytical data revealed that 40% of patients receiving anti-CD20 and S1P disease-modifying therapies (DMTs) generated an antibody response to the COVID-19 vaccine.

Approximately 92% of patients in the study analysis received mRNA vaccines, with immune responses measured using immunoglobulin G (IgG) assays. Data for the study were derived from blood samples provided by the MSPATHS network, and preliminary results indicate that anti-CD20 and sphingosine-1-phosphate (S1P) therapies may reduce antibody responses to COVID-19 vaccination. The study also evaluated the antibody response to vaccination in patients treated with a Biogen multiple sclerosis drug, revealing that the response was consistent with that of patients not receiving disease-modifying therapy for multiple sclerosis.

Biogen Chief Medical Officer Maha Radhakrishnan stated that the findings of this analysis provide critical information for multiple sclerosis (MS) patients during the global COVID-19 pandemic. She further noted that the company aims to equip MS patients and caregivers with relevant information so they can understand their level of protection against the coronavirus. In a statement, Radhakrishnan highlighted that leveraging the unique MS PATHS network enabled Biogen to rapidly generate data on how different MS disease-modifying therapies (DMTs) impact antibody responses to COVID-19 vaccines. This effort is part of a comprehensive initiative to understand B and T cell activation and augments researchers' ongoing efforts to collect these critical antibody data.

`Sanofi`

Sanofi also shared trial data for its experimental multiple sclerosis drug Tolebrutinib, an oral brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor. Data demonstrated that Tolebrutinib exhibited safety and efficacy in patients with relapsing multiple sclerosis. Results from the Phase IIb long-term extension study for relapsing multiple sclerosis indicated that after 48 weeks of treatment, Tolebrutinib reduced disease activity in MS. The trial results confirmed a favorable safety and efficacy profile for Tolebrutinib. Patients treated with 60 mg of Tolebrutinib exhibited a lower annualized relapse rate over the 48-week period, during which the majority of patients (89.5%) remained relapse-free.

Additionally, tolebrutinib is being evaluated in multiple Phase III clinical trials, including for the treatment of relapsing multiple sclerosis, as well as non-relapsing secondary progressive multiple sclerosis and primary progressive multiple sclerosis. Erik Wallstrom, Head of the Neurology Therapeutic Area at Sanofi, noted that these studies are critical to understanding how brain-penetrant therapies mitigate the cumulative risk of disability progression in patients with MS. In a statement, he said that tolebrutinib has the potential to "bring new hope to patients with refractory multiple sclerosis."

According to Sanofi, this data establishes tolebrutinib as the only BTK inhibitor in development for multiple sclerosis that has been shown to directly modulate microglia. Additionally, Sanofi disclosed data on the effects of tolebrutinib on human microglia, which the company stated will further support tolebrutinib’s ability to directly modulate neuroinflammatory processes within the central nervous system (CNS).

Additionally, at the ECTRIMS congress, Bristol Myers Squibb also presented further data from the long-term DAYBREAK study of Zeposia (oral, once daily) for the treatment of MS. This study pooled patients from three earlier trials. Among 2,494 patients with RMS, the annualized relapse rate (AAR) with Zeposia treatment was 0.1. In this open-label extension study, as of the data cutoff, the mean duration of Zeposia treatment was 46.8 months.

References:

1.Glimmers of Hope in MS as Genentech, Sanofi and Biogen Present at ECTRIMS

2.Sanofi’s BTK inhibitor tolebrutinib shows ‘promising’ long-term MS data