Roche Reports Ocrevus Achieves 85% No Evidence of Disease Activity in Early Relapsing-Remitting Multiple Sclerosis Patients

Roche Announces Positive Results for CD20 Antibody Ocrevus (ocrelizumab) in Treating Patients with Early-Stage Multiple Sclerosis (MS)Interim data analysis from the open-label, Phase 3b ENSEMBLE clinical trial showed that 85% of treatment-naïve patients with early relapsing-remitting multiple sclerosis (RRMS) exhibited no signs of disease progression after 48 weeks of treatment with Ocrevus.

Multiple sclerosis (MS) is a chronic autoimmune disease resulting from the immune system attacking the myelin sheath that protects nerves. The progression of MS leads to declines in physical functions, such as walking, and cognitive functions, such as memory. There are three main types of MS: relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), and primary progressive multiple sclerosis (PPMS). RRMS is characterized by clearly defined episodes of relapse and remission; that is, relapses, attacks, or worsening of symptoms are followed by periods of partial or complete recovery during which symptoms improve partially or completely without apparent disease progression. However, as the frequency of relapses increases, the condition of most patients gradually worsens. Globally, there are over 2.8 million people with MS, making it one of the leading causes of non-traumatic disability among young adults, with most patients experiencing their initial symptom onset between the ages of 20 and 40.

Ocrevus is a humanized monoclonal antibody that targets CD20-positive B cells. These cells are considered key contributors to the damage of myelin and neuronal axons. By binding to CD20 on the surface of B cells, it achieves the effect of clearing B cells from the circulation. Ocrevus can specifically bind to the CD20 protein expressed on the surface of certain B cells, but does not bind to CD20 on stem cells or plasma cells, thereby preserving important functions of the immune system.

In the Phase 3 ENSEMBLE clinical trial, patients with newly diagnosed disease who had not previously received disease-modifying therapy (DMT) were treated with Ocrevus. Interim analysis showed that after 48 weeks of treatment, 85% of patients exhibited no signs of disease activity (including no relapses, no disability progression, and no new or enlarging brain lesions on MRI). The annualized relapse rate across all patients was 0.005. Furthermore, levels of neurofilament light chain (NfL), a biomarker indicative of neuronal damage, decreased to levels comparable to those in healthy individuals. In the Ocrevus group, baseline NfL levels were 10.5 pg/mL, decreasing to 4.55 pg/mL after 48 weeks of treatment, compared to 4.12 pg/mL in the healthy control group.

“All patients with MS, regardless of the disease subtype, experience disease progression. Therefore, these latest analysis results are encouraging, as they demonstrate that Ocrevus can significantly slow disease progression. Slowing disease progression enables patients with MS to maintain their mobility and manage their disability,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “Moreover, Ocrevus requires only twice-yearly administration, and our data show that this regimen improves treatment adherence among more patients, thereby enhancing patient outcomes.”

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