New Data Further Reinforce Genentech’s Ocrevus (ocrelizumab) as a Highly Effective Treatment for People With Multiple Sclerosis – BioSpace
By daniellenierenberg
Sept. 11, 2020 05:00 UTC
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data that show Ocrevus (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT). Subgroup analysis from the two-year open-label Phase IIIb CASTING study also demonstrates that patients benefit across a wide range of disease related and demographic subgroups, regardless of prior treatment background. Findings will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
For a wide range of people with MS who experienced a suboptimal response to prior treatment, we continue to see evidence that Ocrevus provides significant benefit in slowing disease progression, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. New real-world Ocrevus data show high persistence and adherence to the only B-cell therapy with a twice-yearly dosing schedule, which we know can be very important to both people with MS and their physicians.
Phase IIIb open-label CASTING study
Approximately 75% of RRMS patients (492/658) had no evidence of disease activity (NEDA; brain lesions, relapses and worsening of disability) two years after switching to twice-yearly Ocrevus treatment (with prespecified MRI re-baselining at 8 weeks) in the primary analysis of the CASTING study. Patients enrolled in the study had prior suboptimal response to at least six months of treatment with up to two DMTs. The analysis also showed the proportion of patients achieving NEDA remained consistently high across all measured patient subgroups, including baseline MRI activity, relapse activity, disability level, age and the number of prior DMTs. Further, 78% of patients treated with only one prior DMT compared with 70% of patients treated with two prior DMTs achieved NEDA.
Additionally, patients treated with Ocrevus experienced an improvement in the majority of symptoms measured by SymptoMScreen after two years. SymptoMScreen is a patient-reported outcome tool to assess symptom severity across twelve domains. The most pronounced significant improvements (p<0.001) were seen in sensory symptoms, fatigue and vision, which are important for daily living.
CONFIDENCE real-world safety study
A 97% treatment persistence for Ocrevus patients at 18 months, and strong adherence to infusions every six months, was seen in an interim analysis of more than 1,600 patients in the ongoing German CONFIDENCE study. Separate data from a U.S. commercial claims database that support high persistence and sustained adherence to Ocrevus treatment will also be presented.
Ocrevus longer-term safety data
New safety data as of January 2020 will be presented, representing 5,680 patients with RMS and PPMS and 18,218 patient-years of exposure to Ocrevus, across all Ocrevus clinical trials. These findings further demonstrate the consistently favorable benefit:risk profile of Ocrevus over seven years.
With rapidly growing real-world experience and more than 170,000 people treated globally, Ocrevus has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS [RRMS] and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and primary progressive MS (PPMS). Ocrevus is approved in 92 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.
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 arent apparent or dont 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 persons 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. 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, Alzheimers disease, Huntingtons disease, Parkinsons 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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200910006081/en/
- Jessner's Lymphocytic Infiltration of the Skin Mimicking Rosacea: A Rare Case Presentation - Dermatology Times - April 28th, 2024
- Device improves stem cell generation and chance for accessible Alzheimer's cell therapy | KTH Royal Institute of ... - TT Nyhetsbyrn - April 28th, 2024
- Colossal Creates Elephant Stem Cells for the First Time in Quest to Revive the Woolly Mammoth - Singularity Hub - March 18th, 2024
- Vitamin A could have a key role in both stem cell biology and wound healing: Study - Medical Dialogues - March 10th, 2024
- A dive into the genetic history of India, and the role of vitamin A in skin repair - Science - March 10th, 2024
- Herbosa: Clinic under probe after skin treatments linked to womans death - Philstar.com - January 22nd, 2024
- These Will Be the Biggest Skin-Care Trends of 2024 - Allure - December 28th, 2023
- Sorry, But These 10 Skincare Products Are A Scam - Refinery29 - December 12th, 2023
- Cyclerion Strengthens Board of Directors with Experienced Company Builder and Cutting-edge Innovator - December 4th, 2023
- Aptose Appoints Fletcher Payne Chief Business Officer, Expanding his Executive Role - December 4th, 2023
- Opthea to Present at the FLORetina 2023 Congress - December 4th, 2023
- HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses - December 4th, 2023
- AC Immune Strengthens Management, Appoints Madiha Derouazi as CSO and Christopher Roberts as CFO - December 4th, 2023
- Publication of a transparency notification received from Tolefi SA (Article 14 §1 of the Law of 2 May 2007) - December 4th, 2023
- Annovis Bio Appoints Andrew Walsh as Vice President Finance - December 4th, 2023
- Foghorn Therapeutics Announces Clinical Data from Phase 1 Study of FHD-286, a Novel BRG1/BRM Inhibitor, in Patients with Advanced Hematologic... - December 4th, 2023
- Akari Therapeutics Appoints Experienced Life Sciences Entrepreneur Samir R. Patel, M.D. to Board of Directors - December 4th, 2023
- Ovid Therapeutics to Present Five Abstracts Supporting its Epilepsy Programs at the 77th American Epilepsy Society Annual Meeting (2023) - December 4th, 2023
- Spectral Medical Announces CFO Departure - December 4th, 2023
- Are STEM CELL EXOSOMES the secret to a 'snatched' jawline? Discover the products that influencers are claiming - Daily Mail - November 18th, 2023
- Defence Mechanisms: Four ways your body is protecting you every time you fall sick - indulgexpress - May 16th, 2023
- Treat Yourself to a Spa Day With a $100 Deal on $600 Worth of Products From Elemis, 111SKIN, Nest & More - E! NEWS - May 16th, 2023
- INTERNATIONAL STEM CELL CORP MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-K) - Marketscreener.com - April 5th, 2023
- Skin Regeneration: The Science and How to Boost It - Healthline - March 9th, 2023
- Treat Yourself to a Spa Day With a $100 Deal on $600 Worth of Products From Elemis, U Beauty, Nest & More - E! NEWS - March 1st, 2023
- 7-year-old vows to find a cure for brother in need of bone marrow transplant - WJLA - February 21st, 2023
- World's most radioactive man 'cried blood' as his skin melted in 83-day nightmare - Times Now - February 4th, 2023
- How old are you, really? The answer is written on your face. - National Geographic UK - February 4th, 2023
- Skin: Layers, Structure and Function - Cleveland Clinic - January 27th, 2023
- Human skin | Definition, Layers, Types, & Facts | Britannica - January 27th, 2023
- Skin Disorders: Pictures, Causes, Symptoms, and Treatment - Healthline - January 27th, 2023
- Skin care: 5 tips for healthy skin - Mayo Clinic - January 27th, 2023
- Skin Care and Aging | National Institute on Aging - January 27th, 2023
- Wrinkles - Symptoms and causes - Mayo Clinic - January 27th, 2023
- Dry skin - Symptoms and causes - Mayo Clinic - January 27th, 2023
- Stem cells: a brief history and outlook - Science in the News - January 3rd, 2023
- Still Drinking Green Tea? Doctor Reveals A Healthier Drink With Proven Benefits For Diabetes, Aging, Oxidative Stress, And Cancer - Revyuh - January 3rd, 2023
- RUDN Physician And Russian Scientists Investigate Long-term Effects Of Treating Diabetic Ulcers With Stem Cells - India Education Diary - December 25th, 2022
- The Use of Stem Cells in Burn Wound Healing: A Review - Hindawi - December 1st, 2022
- FACTORFIVE Skincare The Power of Stem Cells for Skin - December 1st, 2022
- Embryonic Stem Cells - The Definitive Guide | Biology Dictionary - December 1st, 2022
- From pro soccer hopeful to hip hop artist with illness and addiction along the way, Tymaz Bagbani releases debut album - Toronto Star - December 1st, 2022
- Stem Cells | The ALS Association - November 22nd, 2022
- What is a stem cell? YourGenome - October 29th, 2022
- Skin Cell - The Definitive Guide | Biology Dictionary - October 29th, 2022
- Explora Journeys Plans Extensive Fitness And Well-Being Initiatives At Sea, Right On Trend - Forbes - October 29th, 2022
- Ahead of the holiday shopping season, Amazon kicks off second annual Holiday Beauty Haul on Oct. 24 - KXAN.com - October 21st, 2022
- Human skin color - Wikipedia - October 13th, 2022
- Mesenchymal Stem Cells | Properties, Process, Functions, & Therapies - October 13th, 2022
- Skin Grafting, Cryopreservation, and Diseases: A Review Article - Cureus - October 13th, 2022
- Anti-ageing cosmetics: Can they turn back the hands of the clock? - The Sunday Guardian Live - The Sunday Guardian - October 13th, 2022
- Brennand named Elizabeth Mears and House Jameson Professor of Psychiatry - Yale News - October 13th, 2022
- The Switch to Regenerative Medicine - Dermatology Times - October 13th, 2022
- Last Chance to Get The Collagen-Infused Massage Oil That Moisturizes Skin & Diminishes Cellulite For Less Than $20 - msnNOW - October 13th, 2022
- Addison's Disease Explained: Causes, Symptoms, And Treatments - Health Digest - October 13th, 2022
- Stem Cells Therapy for Autism: Does it Work? - October 5th, 2022
- Stem-like CD8 T cells mediate response of adoptive cell ... - PubMed - October 5th, 2022
- 6 Under Eye Products You Need To Have STAT - Grazia India - October 5th, 2022
- CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world's premier... - September 27th, 2022
- Reprogramming pig cells leads way for new regenerative therapies - National Hog Farmer - September 27th, 2022
- A glimpse into Indian consumers expectations for cosmetic treatments and consumption insights - The Financial Express - September 27th, 2022
- Tajmeel redefines beauty to give its patients the best results - Gulf News - September 27th, 2022
- Here Is Why You Heal Slower As You Age - Health Digest - September 27th, 2022
- Creating stem cells from minipigs offers promise for improved treatments - University of Wisconsin-Madison - September 19th, 2022
- Israeli Biotech Firm Plans to Create Human Embryos to Harvest Organs, Field Experts Say There are Ethical Concerns - CBN.com - September 19th, 2022
- CellResearch Corporation (CRC) announces positive results of Phase I study for CorLiCyte - PR Newswire - September 19th, 2022
- The best CBD and hemp products for pampering your skin this fall - Leafly - September 19th, 2022
- Benjamin Button For Real? Scientists Are Close To Cracking The Code To Reverse Aging - Worldcrunch - September 19th, 2022
- I took an international trip with my frozen eggs to learn about the fertility industry - MIT Technology Review - September 19th, 2022
- Propanc Biopharma Reports Significant Effects of PRP Against the Tumor Microenvironment - Business Wire - September 11th, 2022
- 6 Ingredients to Avoid Putting on Your Skin - Healthline - September 3rd, 2022
- Regenerative Properties of the Newborn Heart Offers Hope for Those With Congenital Heart Disease - The Epoch Times - September 3rd, 2022
- Meet White Orange: The Vitamin C Skin Care Brand For Sensitive Skin - Bustle - September 3rd, 2022
- Rejuvenation Roundup August 2022 - Lifespan.io News - September 3rd, 2022
- To better understand Parkinson's disease, this San Diego expert sent her own cells to space - The San Diego Union-Tribune - August 26th, 2022
- Inside the race to make human sex cells in the lab - MIT Technology Review - August 26th, 2022
- Global Biomaterials Market to Reach Value of $372.7 Billion by 2028 | Demand For Biomaterials in the Healthcare Industry will Grow by 53% Over the... - August 26th, 2022
- A Groovy Guide to Anti-Aging Products With CBD and Mushrooms - Out Magazine - August 26th, 2022
- New milestone organoid synthesis will boost disease and drug development research - RegMedNet - August 10th, 2022
- Victoria Beckham and Kim Kardashian are fans of Augustinus Baders skincare range - and you can get 20% off - The Mirror - August 10th, 2022