SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling new data from its ongoing FENopta open-label extension study, confirming that its investigational therapy fenebrutinib continues to provide sustained disease suppression in patients with relapsing multiple sclerosis (RMS) for up to two years.
The 96-week results presented at the CMSC Annual Meeting in Phoenix highlight fenebrutinib’s potential as a first-in-class reversible Bruton’s tyrosine kinase (BTK) inhibitor in the multiple sclerosis space. This development is poised to influence treatment paradigms, particularly as Phase III results approach later this year.
Sustained Disease Control With No Observed Disability Progression
According to Roche, 99 patients entered the open-label extension (OLE) and 93 remained on treatment after 96 weeks. During this period, patients experienced a remarkably low annualized relapse rate (ARR) of 0.06—equivalent to one relapse every 17 years. Importantly, there was no observed progression of disability as measured by the Expanded Disability Status Scale (EDSS).
MRI data further supports fenebrutinib’s efficacy. After 96 weeks, patients exhibited no new T1 gadolinium-enhancing lesions—markers of active brain inflammation. Patients who transitioned from placebo to fenebrutinib in the OLE saw their rate of new or enlarging T2 lesions plummet from 6.72 to 0.34.
“These data show that patients treated with fenebrutinib experienced an annualised relapse rate equal to one relapse every 17 years and no observed disability progression up to two years,’’ said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Fenebrutinib is potent, highly selective and the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis, and we look forward to seeing the first of those results later this year.”
Safety Remains Consistent With Prior Trials
Roche reports that the safety profile remained consistent with previous findings. The most common adverse events (≥5% of patients) were:
- COVID-19 (10%)
- Urinary tract infection (10%)
- Pharyngitis (6%)
- Respiratory tract infection (5%)
Two serious adverse events were observed, and one asymptomatic liver enzyme elevation resolved after treatment discontinuation.
Advancing Toward a Broader Market Impact
Three Phase III studies—FENhance 1 and 2 for RMS, and FENtrepid for primary progressive multiple sclerosis (PPMS)—are ongoing. Initial data from these trials are expected by the end of 2025 and will provide critical insight into fenebrutinib’s long-term potential in addressing the full MS spectrum.
Fenebrutinib, a potent and highly selective BTK inhibitor, is distinguished by its reversibility and non-covalent binding. It uniquely targets both B-cell and microglial activation—mechanisms believed to drive both relapses and chronic progression in MS.
Strategic Implications in the Neuroscience Pipeline
This announcement reinforces Roche’s strategic focus on neuroscience, an area where the company is actively pursuing more than a dozen investigational therapies across diseases such as Alzheimer’s, Parkinson’s, and Huntington’s.
With over 2,700 patients already enrolled across fenebrutinib’s Phase I–III programs, including in autoimmune indications, Roche is positioned to significantly broaden its influence in immunology and neurology through targeted, high-impact innovations.
Learn more at www.roche.com.