Investigational therapy reduced chronic active brain lesion markers and annualised relapse rates, while new Ocrevus and Enspryng data highlight progress across neurological diseases.
Date: October 21, 2026
Company: Roche
Investigational Drug: Fenebrutinib
Therapeutic Area: Neurology / Multiple Sclerosis
Clinical Development: Phase III
Key Highlights
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Reduced Chronic Brain Lesions: Fenebrutinib reduced the volume of slowly expanding lesions by up to 30% in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), compared with active comparators.
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Lower Lesion Accumulation: In RMS, fenebrutinib reduced the accumulation of paramagnetic rim lesions by 62% versus active comparators.
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Lower Relapse Rate: Pooled Phase III RMS data showed a 55% reduction in the annualised relapse rate compared with the active comparator.
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Comprehensive Disease Control: Approximately 75% of fenebrutinib-treated patients achieved no evidence of disease activity (NEDA-3) in pooled RMS trials, representing a 70% reduction in the measure of disease activity versus the comparator.
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Additional Portfolio Progress: Ocrevus data showed that 90% of children aged 10–17 remained relapse-free over two years, while exploratory Enspryng findings indicated improved recovery following relapses in patients with MOGAD.
Clinical Significance
Fenebrutinib is an investigational oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor designed to cross the blood-brain barrier. It targets B cells involved in acute inflammation and microglia associated with chronic inflammation in the central nervous system.
The findings from the FENhance 1 and 2 trials in RMS and the FENtrepid trial in PPMS suggest that fenebrutinib may address both inflammatory disease activity and markers associated with long-term disability progression.
Additional Pipeline Updates
Ocrevus (ocrelizumab): New Phase III data from the OPERETTA 2 study showed that 90% of children with relapsing-remitting MS remained relapse-free over two years. The European Commission approved Ocrevus for paediatric MS on October 15, 2026.
Enspryng (satralizumab): Exploratory Phase III METEOROID analyses in MOGAD showed numerically better recovery following relapse compared with placebo. The investigational use in MOGAD remains subject to regulatory review in the United States.
What’s Next?
Roche presented these findings at MSToronto2026, the 10th ACTRIMS–ECTRIMS meeting, held October 21–23, 2026, in Toronto. Further evaluation will be important to establish fenebrutinib’s long-term efficacy and safety and its potential role in treating relapsing and progressive forms of multiple sclerosis.
Source: Roche — October 21, 2026.
