By VETTAPHARMA reporter: Swiss drugmaker Roche announced promising late-breaking clinical trial results showing its investigational oral medicine, fenebrutinib, may reduce disability progression in people living with primary progressive multiple sclerosis (PPMS)—a form of MS with limited treatment options.
At the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026, Roche unveiled new data from the Phase III FENtrepid study, in which fenebrutinib met its primary endpoint of non-inferiority compared with OCREVUS® (ocrelizumab), the only currently approved therapy for PPMS.
- The study showed fenebrutinib reduced the risk of disability progression by 12% compared with OCREVUS, based on a composite measure combining walking speed, upper limb function, and disability scores.
- Benefits were observed as early as 24 weeks, with notable improvements in measures of upper limb function.
- A post-hoc analysis suggested fenebrutinib may reduce risk by 22% on a composite endpoint including disability score and upper limb tests.
Roche highlighted that fenebrutinib, an oral and brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor, has the potential to become the first new class of MS treatment for PPMS and may also benefit people with relapsing forms of MS.
Although adverse events—including infections, nausea, and transient liver enzyme changes—were reported, they were generally similar between fenebrutinib and OCREVUS study arms, and no pattern in timing or cause was observed for fatal cases in the trial.
Roche plans to submit regulatory filings for fenebrutinib in both PPMS and relapsing MS (RMS) following data from additional Phase III studies expected in the first half of 2026.
Key Numbers
- 12% reduction in disability progression risk vs OCREVUS in main analysis.
- 22% reduction in certain composite endpoints in post-hoc analysis.
- Trial enrolled 985 adult participants with PPMS.
Source credit:
- Roche. (2026, February 7). Roche’s fenebrutinib is the first investigational medicine in over a decade that reduces disability progression in primary progressive multiple sclerosis (PPMS). Click here
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