Genentech 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 -
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 Genentech’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., Genentech’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 revolutionized 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
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
Infant B-cell levels also remained within normal range after 13 months in
Ocrevus in pediatric 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 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.
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 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.
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, 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.
About Ocrevus® (ocrelizumab)
Ocrevus 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® [ocrelizumab hyaluronidase-ocsq] in the
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 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.
About multiple sclerosis
Multiple 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.
People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their symptoms aren’t apparent or don’t 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.
Relapsing-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
About Genentech in neuroscience
Neuroscience 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.
Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, Alzheimer’s disease, Huntington’s disease, Parkinson’s 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.
About Genentech Access Solutions
Access Solutions is part of Genentech’s 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
About Genentech
Founded 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
Indications and Important Safety Information
What are Ocrevus and Ocrevus Zunovo?
Ocrevus and Ocrevus Zunovo are prescription medicines used to treat:
- Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
- Primary progressive MS, in adults.
It is not known if Ocrevus and Ocrevus Zunovo are safe and effective in children.
Who should not receive Ocrevus and Ocrevus Zunovo?
Do not receive Ocrevus or Ocrevus Zunovo if you:
- have an active hepatitis B virus (HBV) infection.
- have had a life-threatening administration reaction to ocrelizumab.
- have had a life-threatening allergic reaction to ocrelizumab, hyaluronidase, or any of the ingredients of Ocrevus Zunovo. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or Ocrevus Zunovo or any of their ingredients in the past.
What is the most important information I should know about Ocrevus and Ocrevus Zunovo?
Ocrevus and Ocrevus Zunovo can cause serious side effects, including:
- Infusion reactions (Ocrevus): Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction.
- Injection reactions (Ocrevus Zunovo): Injection reactions are a common side effect of Ocrevus Zunovo, which can be serious and may require you to be hospitalized. You will be monitored for signs and symptoms of an injection reaction when you receive Ocrevus Zunovo. This will happen during all injections for at least 1 hour after your first injection, and for at least 15 minutes after all injections following the first injection.
Tell your healthcare provider or nurse if you get any of these symptoms:
- itchy skin
- rash
- hives
- tiredness
- coughing or wheezing
- trouble breathing
- throat irritation or pain
- feeling faint
- fever
- redness on your face (flushing)
- nausea
- headache
- swelling of the throat
- dizziness
- shortness of breath
- fatigue
- fast heartbeat
Additionally, for Ocrevus Zunovo:
- injection site pain
- swelling
- redness
These infusion and injection reactions can happen during or up to 24 hours after administration. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion or injection.
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Infection:
- Infections are a common side effect. Ocrevus and Ocrevus Zunovo increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus and Ocrevus Zunovo, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus or Ocrevus Zunovo. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus or Ocrevus Zunovo until your infection is gone.
- Hepatitis B virus (HBV) reactivation: Before starting treatment with ocrelizumab, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus or Ocrevus Zunovo. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus or Ocrevus Zunovo.
- Weakened immune system: Ocrevus or Ocrevus Zunovo taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
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Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with ocrelizumab. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
- thinking
- eyesight
- strength
- balance
- weakness on 1 side of your body
- using your arms or legs
- Decreased immunoglobulins: Ocrevus and Ocrevus Zunovo may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.
Before receiving Ocrevus or Ocrevus Zunovo, tell your healthcare provider about all of your medical conditions, including if you:
- have or think you have an infection. See “What is the most important information I should know about Ocrevus and Ocrevus Zunovo?”
- have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
- have ever had hepatitis B or are a carrier of the hepatitis B virus.
- have a history of inflammatory bowel disease or colitis.
- have a history of liver problems.
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have had a recent vaccination or are scheduled to receive any vaccinations.
- You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus or Ocrevus Zunovo. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus or Ocrevus Zunovo and until your healthcare provider tells you that your immune system is no longer weakened.
- When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus or Ocrevus Zunovo. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus or Ocrevus Zunovo, talk to your healthcare provider.
- If you have a baby and you received Ocrevus or Ocrevus Zunovo during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Ocrevus or Ocrevus Zunovo so they can decide when your baby should be vaccinated.
- are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus and Ocrevus Zunovo will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and Ocrevus Zunovo and for 6 months after your last dose of Ocrevus or Ocrevus Zunovo. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving Ocrevus or Ocrevus Zunovo.
- are breastfeeding or plan to breastfeed. It is not known if Ocrevus and Ocrevus Zunovo pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus or Ocrevus Zunovo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of Ocrevus and Ocrevus Zunovo?
Ocrevus and Ocrevus Zunovo may cause serious side effects, including:
- Risk of cancers (malignancies) including breast cancer: Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
-
Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
- Diarrhea (loose stools) or more frequent bowel movements than usual
- Stools that are black, tarry, sticky or have blood or mucus
- Severe stomach-area (abdomen) pain or tenderness
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Liver damage. Ocrevus and Ocrevus Zunovo may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start Ocrevus or Ocrevus Zunovo and while you take Ocrevus or Ocrevus Zunovo if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as:
- yellowing of the skin and eyes (jaundice)
- nausea
- vomiting
- unusual darkening of the urine
- feeling tired or weak
The most common side effects of Ocrevus Zunovo include:
- Injection reactions
- Respiratory tract infections
- Skin infections
These are not all the possible side effects of Ocrevus and Ocrevus Zunovo.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.
For more information, go to https://www.Ocrevus.com or call 1-844-627-3887.
For additional safety information, please see the full Prescribing Information and Medication Guide for Ocrevus.
For additional safety information, please see the full Prescribing Information and Medication Guide for Ocrevus Zunovo.
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