ECTRIMS 2025: Roche Data Reinforces OCREVUS Efficacy and Highlights Fenebrutinib’s Potential in Multiple Sclerosis Treatment
Major MS Data Presented at ECTRIMS: Long-Term OCREVUS Safety Confirmed; Fenebrutinib Phase II Shows Near-Complete Disease Suppression
Introduction
At the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Roche presented a substantial body of new data on its multiple sclerosis portfolio. The findings reinforced the established efficacy and safety profile of OCREVUS® (ocrelizumab) across diverse patient groups, while offering encouraging two-year results for the investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, fenebrutinib.
Section 1: OCREVUS – Expanding Efficacy Across Diverse Populations
OCREVUS, the first and only FDA-approved treatment for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), showcased strong results, proving its role in halting disability progression:
A. Advanced PPMS Patients Benefit
Late-breaking data from the Phase IIIb ORATORIO-HAND study demonstrated that OCREVUS significantly reduced the risk of confirmed disability progression (cCDP) by 30% in adults with advanced PPMS, including older patients and those with a higher Expanded Disability Status Scale (EDSS) score (up to 8.0). This benefit was even more pronounced (a 55% reduction) in patients who had MRI lesion activity at baseline.
B. Safety During Key Life Moments
Analysis from the ocrelizumab pregnancy registry reinforced that in-utero exposure to the drug does not increase the risk of adverse pregnancy or infant outcomes. Furthermore, one-year data showed that the majority of infants potentially exposed to OCREVUS during pregnancy or breastfeeding exhibited meaningful antibody responses to common childhood vaccines, addressing a key safety concern for women with MS planning a family.
C. Subcutaneous Formulation Consistency
Final two-year data from the Phase III OCARINA II study confirmed that the subcutaneous (SC) injection of OCREVUS maintains a benefit-risk profile consistent with the established intravenous (IV) infusion, offering patients and physicians a preferred, shorter administration option.
Section 2: Fenebrutinib – The Potential of Dual BTK Inhibition
The investigational oral BTK inhibitor fenebrutinib presented highly positive two-year results from the Phase II FENopta open-label extension (OLE) study in patients with relapsing MS (RMS):
- Disease Suppression: Patients maintained near-complete suppression of disease activity at 96 weeks.
- Relapse and Progression: The annualised relapse rate (ARR) was extremely low at 0.06, and no disability progression was observed as measured by the EDSS.
- Active Inflammation: MRI scans detected zero new T1 gadolinium-enhancing (T1-Gd+) lesions at the two-year mark.
Fenebrutinib’s strength lies in its dual mechanism, inhibiting both B-cell and microglia activation. This ability to cross the central nervous system (CNS) has the potential to address the underlying chronic inflammation and nerve damage that drive disability progression in MS.
Conclusion: A Decade of Advancement
These presentations at ECTRIMS 2025 underscore the decade-long scientific advancement in MS treatment, moving beyond simply reducing relapses to actively slowing disability progression. The robust data for OCREVUS solidifies its role as a foundational treatment, while the compelling early data for fenebrutinib positions it as a key potential player in the next generation of MS therapies.
[CRITICAL: Disclaimer & Source Section]
Medical Disclaimer: The information presented here is for informational and educational purposes only and should not be considered medical advice. Patients should always consult with a qualified healthcare professional regarding any medical condition or treatment plan. We are reporting on the results of clinical trials and conference presentations; this is not a final product approval.
Source: This article is based on the official media release from Roche dated September 24, 2025, detailing presentations at ECTRIMS 2025.
Author/Reviewer:Xpharma China
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