ECTRIMS 2025: OCREVUS confirms benefit in advanced PPMS and paediatric MS as fenebrutinib shows durable two-year results

ECTRIMS 2025: OCREVUS confirms benefit in advanced PPMS and paediatric MS as fenebrutinib shows durable two-year results

(IN BRIEF) Roche presented new data at ECTRIMS 2025 confirming that OCREVUS provides sustained protection against disability progression and maintains a consistent safety profile across multiple MS populations, including adults with advanced PPMS, children with RRMS, and women who are pregnant or breastfeeding. Late-breaking results from the ORATORIO-HAND study showed OCREVUS reduced the risk of disability progression by 30% overall and by 55% in patients with active lesions. Infant studies confirmed normal antibody responses to vaccines despite maternal exposure. Final two-year data from the OCARINA II study validated the benefit-risk consistency of subcutaneous OCREVUS compared to IV infusion. Roche also presented two-year Phase II data for fenebrutinib, which showed near-complete suppression of disease activity and stable nerve health markers, with pivotal Phase III results expected later this year.

(PRESS RELEASE) BASEL, 24-Sep-2025 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced a broad set of new findings for its multiple sclerosis (MS) portfolio at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona. Results highlight the sustained effectiveness of OCREVUS® (ocrelizumab) across different MS populations and demonstrate promising two-year outcomes with the investigational BTK inhibitor fenebrutinib.

Data from several late-breaking studies confirm that OCREVUS continues to provide strong protection against disability progression in adults with advanced primary progressive multiple sclerosis (PPMS), while new analyses also reinforce its safety for women who are pregnant or breastfeeding and their infants. In addition, Roche is presenting the first pivotal data in pediatric relapsing-remitting multiple sclerosis (RRMS) comparing OCREVUS to an approved therapy. From its pipeline, Roche also shared two-year Phase II results for fenebrutinib, showing near-complete disease activity suppression at 96 weeks.

“With more than a decade of evidence, OCREVUS has reshaped MS treatment, and these latest results show it continues to help people at different stages of life and disease,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche. “We are equally encouraged by the durable results of fenebrutinib, which may represent a new generation of MS therapies.”

Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences, added: “This year marks more than 10 years since the first pivotal OCREVUS data were presented, and today’s findings reflect how far MS science has advanced. Continued innovation is essential to further reduce relapses and progression so that people with MS can live fuller lives.”

Key highlights presented at ECTRIMS 2025

• OCREVUS subcutaneous (SC) Phase III OCARINA II: Final two-year data show that SC administration maintains a benefit-risk profile consistent with intravenous (IV) infusion, with sustained suppression of relapses, brain lesions, and disability progression.

• ORATORIO-HAND Phase IIIb: In a broader PPMS population (including older adults up to age 65 and patients with advanced disability), OCREVUS reduced the risk of 12-week confirmed disability progression by 30% versus placebo over a median of 2.75 years (p=0.0007). Patients with MRI lesion activity at baseline experienced a 55% reduction (p<0.0001). OCREVUS also delayed worsening of upper limb function, an important measure of independence. No new safety signals were observed.

• Pregnancy and infant outcomes: Data from more than 5,000 pregnancies in the ocrelizumab registry confirm no increased risk of adverse outcomes. Results from the MINORE and SOPRANINO studies showed that the majority of infants with in-utero or breastfeeding exposure to OCREVUS mounted protective antibody responses to routine vaccines within the first year of life, while B-cell levels remained normal.

• Paediatric RRMS: The Phase III OPERETTA 2 trial, to be presented on 26 September, is the first pediatric-onset MS study comparing OCREVUS with fingolimod. Additional long-term results from OPERETTA 1 (96 weeks) will also be shared.

• Fenebrutinib Phase II FENopta OLE: After 96 weeks, patients with relapsing MS maintained a very low annualized relapse rate (0.06), no disability progression, and zero new gadolinium-enhancing lesions. Neurofilament light chain levels decreased to the healthy donor range and remained stable into year two. Three Phase III studies—FENhance I and II in RMS and FENtrepid in PPMS—are ongoing, with first data from FENtrepid expected by the end of 2025.

In total, Roche will present 25 abstracts at ECTRIMS 2025, including six oral and four late-breaking presentations, further underscoring the company’s leadership in advancing MS science.

About OCREVUS® (ocrelizumab)
OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. OCREVUS IV and OCREVUS subcutaneous (SC; marketed as OCREVUS ZUNOVO® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both OCREVUS IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. OCREVUS SC is given as a single 920 mg subcutaneous injection every six months.

About fenebrutinib
Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimized pharmacokinetics (PK) profile. Fenebrutinib has been shown to be 130 times more selective for BTK vs. other kinases. Fenebrutinib is an inhibitor of both B-cell and microglia activation. This dual inhibition may be able to reduce both multiple sclerosis disease activity and disability progression, thereby potentially addressing the key unmet medical need of disability progression in people living with multiple sclerosis and providing comprehensive MS care. The fenebrutinib Phase III programme includes two identical trials in relapsing multiple sclerosis (RMS) (FENhance 1 & 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against OCREVUS.

About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

Approximately 85% of people with multiple sclerosis have a relapsing form of the disease (RMS) characterised by relapses and also worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS®, there had been no FDA-approved treatments for PPMS and OCREVUS is still the only approved treatment for PPMS.

About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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SOURCE: Roche