{"id":61913,"date":"2025-09-24T10:05:07","date_gmt":"2025-09-24T08:05:07","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/genentech-presents-new-data-for-ocrevus-and-fenebrutinib-across-broad-patient-populations-at-ectrims-2025\/"},"modified":"2025-09-24T10:05:07","modified_gmt":"2025-09-24T08:05:07","slug":"genentech-presents-new-data-for-ocrevus-and-fenebrutinib-across-broad-patient-populations-at-ectrims-2025","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/genentech-presents-new-data-for-ocrevus-and-fenebrutinib-across-broad-patient-populations-at-ectrims-2025\/","title":{"rendered":"Genentech Presents New Data for Ocrevus and Fenebrutinib Across Broad Patient Populations at ECTRIMS 2025"},"content":{"rendered":"
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\n– Ocrevus subcutaneous maintains consistent benefit-risk profile after two years –<\/i><\/p>\n

\n– New late-breaking data confirms Ocrevus significantly reduces disability progression in adults with advanced PPMS –<\/i><\/p>\n

\n– One-year data reinforce that majority of infants potentially exposed to Ocrevus during pregnancy or breastfeeding exhibit antibody responses –<\/i><\/p>\n

\n– Fenebrutinib two-year Phase II data demonstrate near-complete suppression of disease activity at 96 weeks –<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presents new data for Ocrevus\u00ae<\/sup> (ocrelizumab) and the investigational Bruton\u2019s tyrosine kinase (BTK) inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain (September 24-26).<\/p>\n

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\nNew 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 Genentech\u2019s 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.<\/p>\n

\n“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,\u201d said Levi Garraway, M.D., Ph.D., Genentech\u2019s chief medical officer and head of Global Product Development. \u201cWith 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.\u201d<\/p>\n

\n\u201cECTRIMS 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 revolutionized MS management by focusing on slowing disease progression,\u201d said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences. \u201cWhile 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\u2019s breadth of data demonstrates our collective commitment towards achieving these goals.\u201d<\/p>\n

\nTwo-year Ocrevus subcutaneous Phase III data<\/b><\/p>\n

\nFinal 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.<\/p>\n

\nPhase IIIb Ocrevus results in broad PPMS population<\/b><\/p>\n

\nThe 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.<\/p>\n

\nOcrevus 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).<\/p>\n

\nIn 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).<\/p>\n

\nThe 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.<\/p>\n

\nInfant outcomes in pregnant and breastfeeding women treated with Ocrevus<\/b><\/p>\n

\nAn 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.<\/p>\n

\nThe 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\u2019s pregnancy in MINORE and in 78-100% of infants with potential exposure to Ocrevus during breastfeeding in SOPRANINO. This means these children can recognize and fight the disease if encountered later, preventing severe illness and long-term harm.<\/p>\n

\nInfant 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.<\/p>\n

\nOcrevus in pediatric RRMS<\/b><\/p>\n

\nLate-breaking data from the Phase III OPERETTA 2 study investigating efficacy and safety of Ocrevus in children 10\u201317 years of age with RRMS will be presented on September 26 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 pediatric study will be an oral presentation on September 25 at 15:15 CEST.<\/p>\n

\nFenebrutinib two-year Phase II FENopta OLE results<\/b><\/p>\n

\nTwo-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 annualized 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.<\/p>\n

\nNeurofilament 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.<\/p>\n

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

\nAbout Ocrevus\u00ae<\/sup> (ocrelizumab)<\/b><\/p>\n

\nOcrevus is a humanized 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\u00ae<\/sup> [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.<\/p>\n

\nAbout fenebrutinib<\/b><\/p>\n

\nFenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton\u2019s 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 program 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.<\/p>\n

\nAbout multiple sclerosis<\/b><\/p>\n

\nMultiple sclerosis (MS) is a chronic disease that affects more than 2.9 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of acquired non-traumatic disability in younger adults.<\/p>\n

\nPeople with all forms of MS experience disease progression \u2013 permanent loss of nerve cells in the central nervous system \u2013 from the beginning of their disease even if their symptoms aren\u2019t apparent or don\u2019t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent progression as early as possible.<\/p>\n

\nRelapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (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 MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus intravenous (IV) infusion, there had been no FDA-approved treatments for PPMS and Ocrevus IV and Ocrevus Zunovo are the only approved treatments for PPMS.<\/p>\n

\nAbout Genentech in neuroscience<\/b><\/p>\n

\nNeuroscience is a major focus of research and development at Genentech and 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.<\/p>\n

\nGenentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, Alzheimer\u2019s disease, Huntington\u2019s disease, Parkinson\u2019s disease, Duchenne muscular dystrophy and autism spectrum disorder. 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.<\/p>\n

\nAbout Genentech Access Solutions<\/b><\/p>\n

\nAccess Solutions is part of Genentech\u2019s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS\/(866) 422-2377 or visit http:\/\/www.Genentech-Access.com<\/a> for more information.<\/p>\n

\nAbout Genentech<\/b><\/p>\n

\nFounded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http:\/\/www.gene.com<\/a>.<\/p>\n

\nIndications and Important Safety Information<\/b><\/p>\n

\nWhat are Ocrevus and Ocrevus Zunovo?<\/b><\/p>\n

\nOcrevus and Ocrevus Zunovo are prescription medicines used to treat:<\/p>\n