Genentech’s ocrelizumab Significantly Reduced Both Relapses & Disability Progression versus interferon beta-1a (Rebif®) in...
June 30 2015 - 1:00AM
Business Wire
- Studies showed superiority on primary
and major secondary endpoints in people with relapsing forms
of multiple sclerosis
- Genentech will submit data to the U.S.
Food and Drug Administration
- Phase III study in primary progressive
multiple sclerosis ongoing
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced positive results from two pivotal studies
evaluating the investigational medicine ocrelizumab compared with
interferon beta-1a (Rebif®), a standard-of-care therapy, in people
with relapsing multiple sclerosis (MS), the most common form of the
disease. The studies (called OPERA I and OPERA II) met their
primary and major secondary endpoints.
Treatment with ocrelizumab significantly reduced the annualized
relapse rate (ARR) over a two-year period compared with interferon
beta-1a, the primary endpoint in both studies. Ocrelizumab also
significantly reduced the progression of clinical disability
compared with interferon beta-1a, as measured by the Expanded
Disability Status Scale (EDSS).
Additionally, treatment with ocrelizumab led to a significant
reduction in the number of lesions in the brain (areas of disease
activity) compared with interferon beta-1a, as measured by MRI.
Overall, the incidence of adverse events associated with
ocrelizumab was similar to interferon beta-1a in both studies; the
most common adverse events were mild-to-moderate infusion-related
reactions. The incidence of serious adverse events associated with
ocrelizumab, including serious infections, was also similar to
interferon beta-1a.
“Ocrelizumab showed remarkable improvements over a
standard-of-care medicine across clinical and imaging endpoints in
two pivotal studies,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “Ocrelizumab has
the potential to make a meaningful difference for people with MS, a
chronic and debilitating disease. Based on these compelling
results, we plan to submit the data for review to U.S. and EU
regulatory authorities in the first quarter of 2016.”
Further analyses of the OPERA studies are ongoing and detailed
data will be presented at an upcoming medical congress.
Results from a Phase III study of ocrelizumab in people with
primary progressive MS (PPMS), a different form of MS, are expected
later this year.
About the OPERA Studies
OPERA I and OPERA II are Phase III, randomized, double-blind,
double-dummy, global multi-center studies evaluating the efficacy
and safety of ocrelizumab (600 mg dose administered by intravenous
infusion every six months) compared with interferon beta-1a (44 mcg
dose administered by subcutaneous injection three times per week)
in people with relapsing forms of MS.1 The primary endpoint of the
OPERA studies was annualized protocol-defined relapse rate (ARR) at
two years (96 weeks). Secondary endpoints included time to onset of
confirmed disability progression, the total number of T1
Gadolinium-enhancing lesions, and total number of new and/or
enlarging T2 hyperintense lesions as detected by brain MRI.
The OPERA I and OPERA II studies enrolled a total of 1,656
people with relapsing forms of MS (i.e., relapsing-remitting MS and
secondary-progressive MS with relapses) across 307 sites in 40
countries.
About 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. Ocrelizumab binds to CD20
cell surface proteins expressed on certain B cells, but not on stem
cells or plasma cells. Therefore the ability to make new B cells is
preserved in people treated with ocrelizumab.
The Phase III clinical development program for ocrelizumab
includes the OPERA I and OPERA II studies in people with relapsing
forms of MS, as well as ORATORIO, a randomized, double-blind,
global multi-center, placebo-controlled study in people with
PPMS.2
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. Our neuroscience research and development program
includes 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.
About Genentech
Founded more than 35 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.
All trademarks used or mentioned in this release are protected
by law. Rebif is a registered trademark of Merck KGaA and EMD
Serono, Inc.
References
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:
https://clinicaltrials.gov/ct2/show/NCT01194570.
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version on businesswire.com: http://www.businesswire.com/news/home/20150629006372/en/
GenentechMedia Contact:Tara Iannuccillo, 650-467-6800Investor
Contacts:Stefan Foser, 650-467-2016Karl Mahler, 011 41 61 687
8503
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