CMSC Press Release: new data from three Phase III studies of the medicine OCREVUS™ (ocrelizumab)
Tuesday, April 12, 2016
Posted by: Elizabeth Porco
GENENTECH TO PRESENT NEW DATA AT AAN SHOWING SUPERIOR EFFICACY OF NVESTIGATIONAL MEDICINE OCRELIZUMAB VERSUS COMPARATORS ON DISEASE ACTIVITY AND PROGRESSION IN TWO FORMS OF MULTIPLE SCLEROSIS
• New analyses showing superior efficacy of ocrelizumab across clinical and subclinical outcomes compared with interferon beta- 1a (Rebif®) in people with relapsing multiple sclerosis (MS) and compared with placebo in primary progressive MS will be presented
SOUTH SAN FRANCISCO, Calif. – April 12, 2016 -- Genentech, a member of the Roche group (SIX: RO, ROG: PTCQX: RHBBY,) announced today that new data from three Phase III studies of the investigational medicine OCREVUS™ (ocrelizumab) will be from April 15-21 in Vancouver, Canada.
In addition, results of a novel endpoint, No Evidence of Disease Activity (NEDA) will be presented from the Phase III studies in relapsing MS at the Clinical Trials Plenary Session on Wednesday, April 20. NEDA is a composite of key measures of disease activity that assesses level of disease control. Patients are considered to have achieved NEDA if they have no relapses, no disability progression and no new or enlarging MRI lesions over a specified time interval, for example, two years of a clinical trial.
“The data being presented at AAN show that ocrelizumab significantly reduced disability progression and brain tissue damage in both relapsing and primary progressive forms of MS,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The analyses demonstrate ocrelizumab’s consistent effect across important measures of disease activity and provide further insights into the clinical effect of ocrelizumab in people with MS.”
Leading investigators will present the following oral and poster presentations:
||Abstract Number (type), Presentation Date, Time
|Immunogenicity with Repeated Dosing of Ocrelizumab in Patients with Multiple Sclerosis
||P2.087 (poster), Sunday, April 17, 4:00
|Preferences for Multiple Sclerosis Treatments: Differences Across Subgroups of Us Patients with RRMS
|P3.108 (poster), Monday, April 18, 5:30
| Myelin Damage in Relapsing Multiple Sclerosis Is Associated with Decreased NAcetylaspartate and Creatine Concentrations
||P4.181 (poster), Tuesday, April 19, 5:30
|Ocrelizumab No Evidence of Disease Activity (NEDA) Status at 96 eeks in Patients with Relapsing Multiple Sclerosis: Analysis of the Phase III Double-Blind, Double-Dummy, Interferon beta-1a-Controlled OPERA I and OPERA II Studies
||PL02.004 (oral), Wednesday, April 20,
9:00 a.m. PDT
|Efficacy and Safety of Ocrelizumab in Primary Progressive Multiple Sclerosis: Results of the Phase III Double-Blind, Placebo-Controlled ORATORIO Study
|S49.001 (oral), Thursday, April 21, 1:00
|Effect of Ocrelizumab on MRI Inflammatory and Neurodegenerative Markers of Disease in Patients with Relapsing Multiple Sclerosis: Analysis of the Phase III, Double-Blind, Double-Dummy, Interferon beta-1a-Controlled OPERA I and OPERA II Studies
||S49.002 (oral), Thursday, April 21, 1:15
|Efficacy of Ocrelizumab in Patients with Relapsing Multiple Sclerosis: Pooled Analysis of Two Identical Phase III, Double-Blind, Double-Dummy, Interferon beta-1a-Controlled Studies
||S49.003 (oral), Thursday, April 21, 1:30
|Effect of Ocrelizumab on Disability Progression in Patients with Relapsing Multiple Sclerosis: Analysis of the Phase III, Double-Blind, Double-Dummy, Interferon beta-1a-Controlled OPERA I and OPERA II Studies
||S49.008 (oral), Thursday, April 21, 2:45
Full session details and data presentation listings for the 2016 AAN annual meeting can be found at the meeting website: https://www.aan.com/conferences/2016-annual-meeting.
In addition, Genentech is sponsoring an Industry Therapeutic Update. Fred Lublin, M.D., professor of Neurology and the director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center, will present “Evolving Perspectives on Disease Activity: What Is Lying Beneath the Surface?” on Tuesday, April 19 at 7:00 p.m. and 8:30 p.m. PDT at the Hyatt Regency Ballroom C in Vancouver.
Follow Genentech on Twitter via @Genentech and keep up to date with AAN 2016 Annual Meeting news and updates by using the hashtag #AANAM.
OCREVUS™ is the proprietary name submitted to the U.S. Food and Drug Administration (FDA) for the investigational medicine ocrelizumab.
Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS. Based on preclinical studies, ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.
The Phase III clinical development program for ocrelizumab (ORCHESTRA) includes three studies: OPERA I, OPERA II and ORATORIO. OPERA I and OPERA II are identical Phase III, randomized, double-blind, double-dummy, global multi-center studies that evaluated the efficacy and safety of ocrelizumab (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS (i.e., relapsing-remitting MS and secondary-progressive MS with relapses).1 ORATORIO is a Phase III, randomized, double-blind, global multi-center study that evaluated the efficacy and safety of ocrelizumab (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with primary progressive MS (PPMS).2
In February 2016, the FDA granted Breakthrough Therapy Designation to ocrelizumab for the treatment of people with PPMS. Ocrelizumab is the first investigational medicine to receive Breakthrough Therapy Designation in multiple sclerosis.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure.3,4 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.5,6,7 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.8
Relapsing MS is the most common form of the disease. Disease activity and progression can occur even when people do not show signs or symptoms of MS, despite available relapsing MS treatments. 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.9 Approximately one in 10 people with MS are diagnosed with the primary progressive form of the disease. There are no approved treatments for PPMS.
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. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease, Down syndrome and autism.
Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or lifethreatening 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.
All trademarks used or mentioned in this release are protected by law. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.
1 F. Hoffmann-La Roche. ClinicalTrials.gov NCT01247324 and NCT01412333. National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT01247324 and https://clinicaltrials.gov/ct2/show/NCT01412333.
2 F. Hoffmann-La Roche. ClinicalTrials.gov NCT01194570. National Library of Medicine. Available at:
3 Multiple Sclerosis International Federation. (2013). Atlas of MS 2013. Available at: http://www.msif.org/aboutus/advocacy/atlas/.
4 National Institutes of Health-National Institute of Neurological Disorders and Stroke. (2015). Multiple Sclerosis: Hope Through Research. Available at: http://www.ninds.nih.gov/disorders/multiple_sclerosis/detail_multiple_sclerosis.htm#280373215.
5 Ziemssen T. (2005). Modulating processes within the central nervous system is central to therapeutic control of multiple sclerosis. J Neurol, 252(Suppl 5), v38-v45.
6 Hauser S.L. et al. (2012). Multiple sclerosis and other demyelinating diseases. In Harrison’s Principles of Internal Medicine (pp.3395-3409). New York, NY: McGraw Hill Medical.
7 Hadjimichael O. et al. (2007). Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain,127(1-2), 35-41.
8 Multiple Sclerosis International Federation. What is MS? Available at http://www.msif.org/about-ms/what-is-ms/. Last accessed January 2015.
9 MS International Federation. Types of MS. Available at: http://www.msif.org/about-ms/types-of-ms/.
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