Monday, Sep 9, 2019
Blood neurofilament light chain (NfL) levels were significantly lowered following Ocrevus treatment in analyses of Phase III studies in RMS and PPMS
New data show NfL may be a biomarker for predicting future disability outcomes
Separate analyses presented from one of the first studies to demonstrate NfL levels are correlated with active MRI lesions in PPMS
South San Francisco, CA -- September 9, 2019 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data from Ocrevus® (ocrelizumab) trials in relapsing and primary progressive multiple sclerosis (MS). The analyses provide new insights into the biology of MS that advance the understanding of disease progression, with the goal of identifying and slowing disease progression as early as possible to preserve patient function over the long term. Findings will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from September 11 – 13 in Stockholm.
Following Ocrevus treatment, blood neurofilament light chain (NfL) levels were lowered to a healthy donor range1 in relapsing MS (RMS) and primary progressive MS (PPMS) patients. NfL is a protein that provides structural support to nerve fibers in the brain. An increase in the amount of NfL may be associated with nerve cell damage, and detection of increased NfL levels in blood or cerebrospinal fluid (CSF) may serve as a biomarker of nerve cell damage. In the Phase III OPERA I study in RMS and the ORATORIO study in PPMS, blood NfL levels were significantly lower after treatment with Ocrevus. In RMS, blood serum NfL levels were reduced by 43% from baseline to 96 weeks after Ocrevus treatment compared with a 31% reduction with interferon beta-1a (p<0.001). In PPMS, blood plasma NfL levels were reduced by 16% from baseline to 96 weeks after Ocrevus treatment compared with 0.2% reduction with placebo (p<0.001). Additionally, these analyses showed higher blood NfL levels at the start of the study were correlated with more disability progression in upper and lower limbs in PPMS and overall disability in the interferon beta-1a RMS treatment group at 96 weeks.
Few studies have described the relationship between NfL levels and MRI in a well-characterized PPMS patient group. New data from the Phase III OBOE study in PPMS and RMS show that PPMS patients with active MRI lesions (gadolinium-enhancing T1 lesions) had median CSF NfL levels twice as high as those without these lesions. As previously reported, RMS patients with active MRI lesions also had significantly higher NfL levels. Collectively, these data around NfL in MS advance the understanding of it as a potential biomarker of disease progression and may provide insight into the potential neuroprotective effects following Ocrevus treatment.
“These analyses from the Ocrevus trials strengthen the evidence for pursuing neurofilament light chain as a potential biomarker of disease activity and progression in MS, including its potential to predict future disability outcomes,” said Amit Bar-Or, M.D., FRCP, FAAN, FANA, chair of the Scientific Steering Committee of the OBOE study and chief of the Multiple Sclerosis Division of the Department of Neurology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia. “Disease progression in MS can be challenging to identify without noticeable relapses or disability progression, and continued investigation into neurofilament light chain may help us better understand the underlying progression in all forms of this disease.”
Ocrevus is the first and only therapy approved for both RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the United States) and PPMS. Ocrevus is dosed every six months, with rapidly increasing real-world experience and more than 120,000 people with MS treated globally. Ocrevus is now approved in 89 countries across North America, South America, the Middle East, and Eastern Europe, as well as in Australia, Switzerland and the European Union.
Full session details and data presentation listings for ECTRIMS can be found at the congress website: https://www.ectrims-congress.eu/2019.html.
Follow Genentech on Twitter via @Genentech and keep up to date with ECTRIMS 2019 news and updates by using the hashtag #ECTRIMS2019.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects nearly one million people in the United States, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle 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 non-traumatic disability in younger adults.
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 85 percent 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 percent of people with MS 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.
People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse. An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a person’s disability progresses. Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and disability progression.
About Ocrevus® (ocrelizumab)
Ocrevus is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS) and PPMS, with dosing every six months. 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. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.
Ocrevus is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.
Important Safety Information
What is Ocrevus?
Ocrevus is a prescription medicine used to treat:
It is not known if Ocrevus is safe or effective in children.
Who should not receive Ocrevus?
Do not receive Ocrevus if you have an active hepatitis B virus (HBV) infection.
Do not receive Ocrevus if you have had a life threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.
What is the most important information I should know about Ocrevus?
Ocrevus can cause serious side effects, including:
These infusion reactions can happen for up to 24 hours after your infusion. 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.
If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:
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?
Ocrevus may cause serious side effects, including:
Most common side effects include infusion reactions and infections.
These are not all the possible side effects of Ocrevus.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
For more information, go to http://www.Ocrevus.com or call 1-844-627-3887.
For additional safety information, please see the full Prescribing Information and Medication Guide.
About Genentech in neuroscience
Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Genentech and Roche have more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism.
About Genentech
Founded more than 40 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/.
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1Samples were taken from 118 healthy donors to establish healthy donor NfL ranges of 5.5–9.8 pg/mL for blood serum and 4.3–7.9 pg/mL for blood plasma. Healthy donor range was defined as the 90th percentile of an age-matched healthy cohort.