Roche presents new data for OCREVUS and fenebrutinib across broad patient populations at ECTRIMS 2025

• OCREVUS subcutaneous maintains consistent benefit-risk profile after two years
• New late-breaking data confirms OCREVUS significantly reduces disability progression in adults with advanced PPMS
• One-year data reinforce that majority of infants potentially exposed to OCREVUS during pregnancy or breastfeeding exhibit antibody responses
• Fenebrutinib two-year Phase II data demonstrate near-complete suppression of disease activity at 96 weeks

Basel, 24 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presents new data for OCREVUS® (ocrelizumab) and the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain (24-26 September).

New data show that treatment with OCREVUS provides significant benefit in preventing disability progression across diverse groups of people with multiple sclerosis (MS), including children with relapsing-remitting multiple sclerosis (RRMS), women with MS who are pregnant or breastfeeding, and adults with advanced primary progressive multiple sclerosis (PPMS). From Roche’s MS pipeline, Phase II data for fenebrutinib showing near-complete suppression of disease activity at 96 weeks will be presented ahead of upcoming pivotal study readouts.

"We have made significant scientific progress in the treatment of MS and improving outcomes for people living with it, including key life moments such as planning for a family,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With over a decade of efficacy and safety evidence, OCREVUS has transformed the course of MS for people with RMS and PPMS, and the new data further reinforce its role in preventing disability progression. We are also encouraged by the potential of fenebrutinib in redefining future treatment.”

“ECTRIMS 2025 marks over a decade of scientific advancement since the first Phase III pivotal data from OCREVUS. The deepened understanding of B cells has led to breakthrough therapies that have revolutionised MS management by focusing on slowing disease progression,” said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences. “While significant progress has been made, continued innovation focused on preventing both relapses and progression is essential to empowering people with MS to live life to the fullest. This year’s breadth of data demonstrates our collective commitment towards achieving these goals.”

Two-year OCREVUS subcutaneous Phase III data
Final data from the Phase III OCARINA II study show that OCREVUS subcutaneous (SC) injection maintains a consistent benefit-risk profile for up to two years, similar to the well-established OCREVUS intravenous infusion (IV), with continued near-complete suppression of relapses, brain lesion activity and disability progression.

Phase IIIb OCREVUS results in broad PPMS population
The ORATORIO-HAND expanded on the PPMS population studied in the registrational ORATORIO study by including older patients (age up to 65) and patients with advanced disability (Expanded Disability Status Scale [EDSS] score up to 8.0), for whom maintaining upper limb function is even more important for preserving quality of life and independence.

OCREVUS shows 30% reduction in the risk of time to onset of 12-week composite confirmed disability progression (cCDP) in adults with advanced PPMS compared to placebo after a median 2.75 years of treatment (p=0.0007) in new late-breaking data from the Phase IIIb ORATORIO-HAND study. An even greater reduction of 55% in the risk of time to onset of 12-week cCDP was observed in patients with MRI lesion activity at baseline (p<0.0001).

In a large PPMS population that included patients with more advanced disease, OCREVUS was superior to placebo in delaying overall disability progression (EDSS) and worsening of upper limb function (9-hole peg test).

The safety profile of OCREVUS was consistent with previous studies, and no new safety signals were reported. OCREVUS is the first and only approved treatment for PPMS, and these data demonstrate that the benefit extends to patients with more advanced disease.

Infant outcomes in pregnant and breastfeeding women treated with OCREVUS
An analysis of more than 5,000 pregnancies from the ocrelizumab pregnancy registry, the largest dataset of pregnancy outcomes for an anti-CD20 therapy in MS, will reinforce previous data that showed in-utero exposure to OCREVUS does not increase the risk of adverse pregnancy or infant outcomes.

The majority of infants with potential OCREVUS exposure during pregnancy or breastfeeding exhibited meaningful antibody responses to childhood vaccines in one-year data from the Phase IV MINORE and SOPRANINO studies. Protective antibody responses to eight common vaccines given in the first year of life were observed in 86-100% of infants with potential exposure to OCREVUS during their mother’s pregnancy in MINORE and in 78-100% of infants with potential exposure to OCREVUS during breastfeeding in SOPRANINO. This means these children can recognise and fight the disease if encountered later, preventing severe illness and long-term harm.

Infant B-cell levels also remained within normal range after 13 months in 95% (n=20/21) of infants in MINORE and 100% (n=11/11) of infants in SOPRANINO. Further data on the growth and development of infants with potential OCREVUS exposure during the first year of life will also be presented.

OCREVUS in paediatric RRMS
Late-breaking data from the Phase III OPERETTA 2 study investigating efficacy and safety of OCREVUS in children 10–17 years of age with RRMS will be presented on 26 September at 10:30 CEST. The OPERETTA 2 presentation will be the first time that data from the primary analysis of a pediatric-onset MS trial comparing a high-efficacy DMT (ocrelizumab) versus a globally approved treatment (fingolimod) will be shown. Also, long-term, 96-week results from the Phase II OPERETTA 1 paediatric study will be an oral presentation on 25 September at 15:15 CEST.

Fenebrutinib two-year Phase II FENopta OLE results
Two-year data from the Phase II FENopta open-label extension (OLE) study will be presented, showing that patients with relapsing multiple sclerosis (RMS) treated with fenebrutinib maintained near-complete suppression of disease activity at 96 weeks. Patients enrolled in the OLE had a low annualised relapse rate (ARR) of 0.06, and during this time, there was no disability progression, as measured by the EDSS. At two years, MRI scans detected zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation.

Neurofilament light chain, a marker of nerve cell damage, was decreased to healthy donor range in the first year and maintained in the second year of fenebrutinb treatment. Three Phase III clinical trials for fenebrutinib are ongoing, including the FENhance I and II studies in RMS and the FENtrepid study in PPMS. Initial data from the FENtrepid study are expected at the end of this year.

In total, Roche will present 25 abstracts, including six oral and four late-breaking presentations at ECTRIMS 2025. Follow Roche on X via @Roche and keep up to date with ECTRIMS 2025 news and updates by using the hashtag #ECTRIMS2025.

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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