Genentech to Present New Data at AAN Showing Superior Efficacy of Investigational Medicine Ocrelizumab Versus Comparators on Disease Activity and Progression in Two Forms of Multiple Sclerosis
About ocrelizumab (OCREVUS™)
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.
Genentech, a member of the Roche group announced today that new data from three Phase III studies of the investigational medicine OCREVUS™ (ocrelizumab) will be presented during the 68th American Academy of Neurology (AAN) annual meeting 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.”
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
Leading investigators will present the following oral and poster presentations:
- Immunogenicity with Repeated Dosing of Ocrelizumab in Patients with Multiple Sclerosis P2.087 (poster), Sunday, April 17, 4:00 p.m. PDT
- Preferences for Multiple Sclerosis Treatments: Differences Across Subgroups of US Patients with RRMS P3.108 (poster), Monday, April 18, 5:30 p.m. PDT
- Myelin Damage in Relapsing Multiple Sclerosis Is Associated with Decreased N-Acetylaspartate and Creatine Concentrations P4.181 (poster), Tuesday, April 19, 5:30 p.m. PDT
- Ocrelizumab No Evidence of Disease Activity (NEDA) Status at 96 Weeks 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
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 p.m. PDT|
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 p.m. PDT|
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 p.m. PDT|
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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.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.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or 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.