Tuesday, Oct 18, 2022
Ocrevus data will show significant benefit on slowing disease activity and progression in patients with treatment-naïve early-stage relapsing-remitting multiple sclerosis (RRMS)
Largest pregnancy safety data across anti-CD20 medicines for Ocrevus in multiple sclerosis (MS)
Nine-year safety data for Ocrevus reinforces its favorable benefit-risk profile
New research demonstrates impact of misdiagnosis and delay of starting treatment in neuromyelitis optica spectrum disorder (NMOSD)
South San Francisco, CA -- October 18, 2022 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new Ocrevus® (ocrelizumab) data and continued research into neuromyelitis optica spectrum disorder (NMOSD) will be presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 26-28, 2022. These data include 35 abstracts, highlighting disease activity and progression results in early-stage relapsing-remitting multiple sclerosis (RRMS), pregnancy outcomes from more than 2,000 women with MS and long-term safety data for Ocrevus, as well as global NMOSD data exploring impact of delayed treatment, clinical characterization of disease severity and stability, and accurate identification of people living with NMOSD through healthcare claims-based algorithms. Finally, the design of a Phase III study evaluating the efficacy and safety of satralizumab in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD), a rare, chronic and debilitating autoimmune disease primarily affecting the optic nerve, brain and spinal cord, will be presented.
“Our aim is to enable people living with MS and NMOSD to maintain life to the fullest. With over 250,000 people treated with Ocrevus, we continue to see significant reductions in MS disease progression balanced with favorable safety,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are also focused on remaining unmet needs – such as earlier diagnosis and treatment – which is critical to ensure patients are receiving the most appropriate treatment.”
Multiple sclerosis (MS)
Genentech will present 29 MS abstracts, including data from a two-year interim analysis of treatment-naïve, early-stage patients with RRMS from the open label Phase IIIb ENSEMBLE study that will show the positive impact on disease activity and progression when newly diagnosed patients are treated with Ocrevus, and outcomes from the largest cumulative pregnancy dataset for an anti-CD20 MS medicine in more than 2,000 women treated with Ocrevus. Long-term data from all Ocrevus clinical trials in relapsing MS (RMS) and primary progressive MS (PPMS) over nine years will reinforce the consistently favorable benefit-risk profile of Ocrevus.
Neuromyelitis optica spectrum disorder (NMOSD)
Genentech will present five NMOSD abstracts, including the development and testing of a healthcare claims-based algorithm to identify people living with NMOSD. Misdiagnosis of NMOSD is common and associated with a delay in initiating maintenance therapy. This was highlighted in a study looking to develop a clearer understanding of patient characteristics, relapse severity and other drivers of treatment choice.
The development of validated consensus statements on AQP4-IgG seropositive NMOSD management will also be presented with a focus on treatment recommendations including satralizumab; these statements aim to optimize patient outcomes through informed treatment decision making. The characterization of disease severity and stability in NMOSD will also be presented, with the aim of integrating these in worldwide NMOSD clinical practice.
Genentech will also present the study design from a Phase III study that will evaluate the efficacy and safety of satralizumab in MOGAD.
Follow Genentech on Twitter via @Genentech and keep up to date with ECTRIMS 2022 news and updates by using the hashtag #ECTRIMS2022.
Medicine and/or Therapeutic Area | Abstract Title | Presentation Number (type) Presentation Date, Time |
e-Posters available from October 26 at 2:00 a.m. ET Poster presentations scheduled for October 26 at 10:30-12:30 p.m. ET unless indicated differently | ||
Ocrevus (ocrelizumab) for Multiple Sclerosis | Pregnancy and Infant Outcomes in Women Receiving Ocrelizumab for the Treatment of Multiple Sclerosis | 0038 (oral)
Wednesday, October 26, 8:49-8:56 a.m. ET |
Treatment-Naive Patients With Early-Stage Relapsing-Remitting Multiple Sclerosis Showed Low Disease Activity After 2-Year Ocrelizumab Therapy, With No New Safety Signals; The Phase IIIb ENSEMBLE Study | P285 (poster)
Thursday, October 27, 7:20-7:25 a.m. ET | |
Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients With Relapsing and Primary Progressive Multiple Sclerosis | P326 (poster)
| |
An Interim Analysis of Efficacy and Safety Data in Black and Hispanic Patients With Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial | P686 (poster)
| |
Demographics and Baseline Disease Characteristics of Patients With Relapsing Multiple Sclerosis From Kenya Participating in the CHIMES Trial | EP1049 (e-poster)
| |
The Patient Perspective on Family Planning Needs and Priorities in Multiple Sclerosis: a Combined Quantitative and Qualitative Research Study | P077 (poster)
| |
Blood Neurofilament Light Levels Predict Non-Relapsing Progression Following Anti-CD20 Therapy in Relapsing and Primary Progressive Multiple Sclerosis: Findings From the Ocrelizumab Randomized, Double-Blind Phase 3 Clinical Trials | P256 (poster)
| |
Identification of Novel CSF Measures of Disease Activity and Chronic Progressive Biology in MS: Results of the Ocrelizumab Biomarker Outcome Evaluation Study (OBOE): A Randomized, Open-Label Clinical Trial | P449 (poster)
Thursday, October 27, 7:34-7:40 a.m. ET | |
Real-World Clinical and Economic Outcomes Among Persons With Multiple Sclerosis Initiating First- vs. Second-Line Treatment With Ocrelizumab | EP1127 (e-poster)
| |
Trends in the Use of Disease-Modifying Therapies in Pre-Pregnant Women With Multiple Sclerosis in the United States: a Claims Database Analysis | P479 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
COVID-19 Vaccination Patterns and Outcomes Among Persons With Multiple Sclerosis in the FlywheelMS Cohort | EP1100 (e-poster)
| |
Ocrelizumab in Patients With Early-Stage RRMS – Results From the Phase IIIb ENSEMBLE Trial and the Matched Real-World NTD MS Registry Cohort | P771 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Safety of Shorter Ocrelizumab Infusion Confirmed Over Multiple Administrations: Results of the ENSEMBLE PLUS Substudy | P739 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Efficacy and Safety of Ocrelizumab is Maintained in Patients with RRMS with Suboptimal Response to Prior Disease-Modifying Therapies: 4-Year NEDA Data from CASTING-LIBERTO | P289 (poster)
| |
Employment and Cognitive Improvements in Ocrelizumab-Treated Patients With Relapsing-Remitting Multiple Sclerosis: 96-Week CASTING Study Data | P776 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Cognitive Improvements in Ocrelizumab-Treated Patients with Relapsing-Remitting Multiple Sclerosis: 96-Week CASTING Study Data | P377 (poster)
| |
Long-Term Efficacy and Safety of Ocrelizumab in Treatment-Naive Patients With Early Relapsing Multiple Sclerosis: 7-year Data From the OPERA Open-Label Extension Trials | P723 (poster)
Thursday, October 27, 7:30-7:35 a.m. ET | |
Eight-Year Analyses of Repeated Confirmed Disability Progressions in the OPERA and ORATORIO Studies and Their Open-Label Extensions | P050 (poster)
| |
Ocrelizumab Dose Selection for Treatment of Relapsing-Remitting Multiple Sclerosis in Children and Adolescents: Preliminary Pharmacokinetic, Safety and Efficacy Results From the OPERETTA 1 Study | P444 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Infusion-Related Reactions With Ocrelizumab in Relapsing Multiple Sclerosis: Over 9 Years of Data From OPERA OLE | P725 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
SARS-CoV-2 Vaccination and COVID-19 Infections in People With Multiple Sclerosis Treated With Ocrelizumab in the Prospective, Multicenter, Noninterventional MuSicalE and CONFIDENCE Studies | P562 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
SARS-CoV-2 Vaccine-induced Immune Responses and Breakthrough Infections in People with Multiple Sclerosis Treated with Ocrelizumab | P553 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Severe COVID-19 Outcomes Following Vaccination in Persons With Multiple Sclerosis: a Real-World Evidence Study | P747 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Longitudinal Study of Humoral and Cellular Responses to COVID-19 mRNA Vaccines With and Without 3rd (“Booster”) Dose in MS Patients on Ocrelizumab: 24-Week Results From VIOLA (NCT04843774) | EP1052 (e-poster)
| |
Clinical and MRI Outcomes in Pediatric-Onset MS Patients on Ocrelizumab and Fingolimod | EP0995 (e-poster)
| |
Floodlight in Multiple Sclerosis | Assessment of Upper Extremity Function and Performance Fatigability in Multiple Sclerosis Using Sensor-Based Features Derived From the Smartphone-Based Pinching Test | O144 (oral)
Friday, October 28, 4:49-4:56 a.m. ET |
Identification of Distinct Adherence Profiles for Smartphone Sensor-Based Tests (Floodlight) in a Study of People With Progressive Multiple Sclerosis (CONSONANCE) | P123 (poster)
| |
Remote Passive Monitoring in People Living With Progressive Multiple Sclerosis During the COVID-19 Pandemic Shows a Measurable Reduction in Daily Activity | P522 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
A Prospective Study of the Feasibility of Smartphone-Based Self-Monitoring to Characterize Cognitive and Neurological Impairment in People With Multiple Sclerosis: Floodlight MS MoreActive | EP0886 (e-poster)
| |
Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder | International, Evidence-based Delphi Consensus on the Management of AQP4-IgG Seropositive NMOSD, With a Focus on Treatment Recommendations for Eculizumab, Inebilizumab and Satralizumab | P008 (poster)
|
Understanding Treatment Decisions in Neuromyelitis Optica Spectrum Disorder: a Global Clinical Record Review With Patient Interviews | P412 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Characterization of Disease Severity and Stability in Neuromyelitis Optica Spectrum Disorder: a Global Clinical Record Review With Patient Interviews | P417 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Development and Validation of a Claims-Based Algorithm to Identify Patients with Neuromyelitis Optica Spectrum Disorder | EP0911 (e-poster) | |
Baseline Characteristics of Initial Patients in the CorEvitas SPHERES Registry for NMOSD | P408 (poster)
Thursday, October 27, 11:00-1:00 p.m. ET | |
Satralizumab for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease | METEOROID: A Randomized, Double-Blind, Placebo-controlled, Multicenter Phase 3 Study of Satralizumab in Patients with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease | EP1040 (e-poster) |
About Ocrevus® (ocrelizumab)
Ocrevus is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the United States) and PPMS. 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.
Indications and Important Safety Information
What is Ocrevus?
Ocrevus is a prescription medicine used to treat:
It is not known if Ocrevus is safe and 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:
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. You may also report side effects to Genentech at (888) 835-2555.
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 EnspryngTM (satralizumab-mwge)
Enspryng, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets interleukin-6 (IL-6) receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD disease processes, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology. When compared to conventional antibodies, Enspryng’s recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) - maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks.
Positive Phase III results for Enspryng, as both monotherapy and in combination with baseline immunosuppressive therapy, suggest that IL-6 inhibition is an effective therapeutic approach for people with NMOSD who are AQP4-IgG seropositive. The Phase III clinical development program for Enspryng includes two studies: SAkuraStar and SAkuraSky.
Enspryng is currently approved in 63 countries, including the United States, Canada, Japan, South Korea and the European Union.
Enspryng has been designated as an orphan drug in the United States, Europe, Japan and Russia. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018, which is given to treatments that may demonstrate substantial improvement over other available options.
Indications and Important Safety Information
Patients should not take Enspryng if they:
Enspryng may cause serious side effects including:
Before taking Enspryng, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of Enspryng include:
For more information about the risk and benefit profile of Enspryng, patients should ask their healthcare provider.
Patients may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at 1-888-835-2555.
Please see the full Prescribing Information for additional Important Safety Information.
About Genentech in neuroscience
Neuroscience is a major focus of research and development at Genentech and Roche. Our goal is to pursue ground-breaking 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, Parkinson’s disease 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
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.
###