Roche’s subcutaneous OCREVUS one-year data demonstrates
near-complete suppression of clinical relapses and brain lesions in
patients with progressive and relapsing forms of MS
- Results from the Phase III
study showed that subcutaneous (SC) injection was consistent with
IV infusion and demonstrated near-complete suppression of relapse
activity (97%) and MRI lesions (97.2%) through 48
weeks
- The twice-yearly, 10-minute
SC injection has the potential to expand the usage of OCREVUS to
treatment centres without IV infrastructure or with IV capacity
limitations
- U.S. FDA and EMA accepted
filings based on the data from OCARINA II, with EU approval
anticipated mid-2024 and U.S. approval anticipated September
2024
Basel, 17 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today data from the Phase III OCARINA II study (S31.006)
of OCREVUS® (ocrelizumab), an investigational twice-yearly,
10-minute subcutaneous (SC) injection. Results showed near-complete
suppression of clinical relapses and brain lesions in people with
relapsing or primary progressive multiple sclerosis (RMS or PPMS)
which reinforce the potential benefits of this investigational
formulation. Treatment with OCREVUS SC led to rapid and sustained
B-cell depletion in the blood. The data will be presented as an
oral presentation at the 76th American Academy of Neurology (AAN)
Annual Meeting taking place April 13-18 in Denver and has been
recognised as an abstract of distinction by the AAN scientific
committee.
“With a full year of data demonstrating near-complete
suppression of relapse activity and minimal progression of lesion
development, this 10-minute subcutaneous OCREVUS injection shows
results that are consistent with the long-established benefits of
intravenous OCREVUS,” said Levi Garraway, M.D., Ph.D., Roche’s
chief medical officer and head of Global Product Development. “We
look forward to continuing ongoing conversations with regulatory
bodies worldwide to potentially bring an additional treatment
option to more people living with MS, in a shorter injection
time.”
Updated, longer-term results showed that OCREVUS SC injection
(920 mg; n=236; both treatment arms [OCR SC/SC and OCR IV/SC])
resulted in near-complete suppression of relapse activity (97.2%
had no relapse during the treatment phase) and MRI up to 48 weeks
with an ARR of 0.04, and most patients having no T1
gadolinium-enhancing (T1 Gd+) lesions and no new/enlarging T2
lesions. These lesion types are markers of active inflammation and
burden of disease, respectively. Additionally, in exploratory
patient reported outcome measures (n=52) patients reported a high
level of satisfaction (92.3% were satisfied or very satisfied) and
convenience (90.1% felt it was convenient or very convenient) with
OCREVUS SC injection.
“Updated results from OCARINA II further underline the potential
benefits of subcutaneous OCREVUS for patients with both relapsing
and progressive forms of MS,” said Scott Newsome, D.O., lead
author, Johns Hopkins University School of Medicine. “Patients
treated with subcutaneous OCREVUS experienced appropriate B-cell
suppression and impressive near-complete suppression of new
inflammatory disease activity. These results demonstrate the
potential of subcutaneous OCREVUS as a treatment option that can be
matched to the individual needs of people with MS and healthcare
professionals.”
Additional data continued to show that the safety profile of
OCREVUS SC injection was consistent with the well-established
safety profile of OCREVUS IV infusion. No new safety signals were
identified for OCREVUS SC. The most common adverse events in the
OCREVUS SC group were injection reactions (51.5% of all exposed
patients), including erythema (34.8%; skin redness or irritation),
pain (17.2%), swelling (9.4%) and pruritus (5.6%; skin itching),
all of which were either mild or moderate and none of which led to
treatment withdrawal. A total of seven serious AEs were experienced
by three (2.6%) and four (3.4%) patients in the OCREVUS SC
injection and IV infusion groups, respectively.
The OCARINA II abstract was selected as an abstract of
distinction by the AAN, based on the quality of the study and the
interest to the neurology community.
The twice-yearly, 10-minute SC injection has the potential to
expand the usage of OCREVUS to treatment centres without IV
infrastructure or with IV capacity limitations. Data from the Phase
III OCARINA II trial were submitted to health authorities around
the world following the first presentation of these results during
ECTRIMS-ACTRIMS 2023. Both the European Medicines Agency (EMA) and
U.S. Food and Drug Administration (FDA) have accepted Roche’s
submissions, with a target decision date of mid-2024 for the EMA
and September 2024 for the FDA.
More than 300,000 people with MS have been treated with OCREVUS
IV globally. OCREVUS IV is approved in more than 100 countries
across North America, South America, the Middle East, Eastern
Europe, Asia, Australia, Switzerland, the United Kingdom and the
EU.
Roche is committed to advancing innovative clinical research
programmes to broaden the scientific understanding of MS, further
reducing disability progression in RMS and PPMS and improving the
treatment experiences for those living with the disease. There are
more than 30 ongoing OCREVUS clinical trials designed to help us
better understand MS and its progression.
About the subcutaneous formulation of OCREVUS
(ocrelizumab)
The investigational subcutaneous (SC) formulation combines OCREVUS
with Halozyme Therapeutics’ Enhanze® drug delivery technology.
OCREVUS is a humanised 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.
The Enhanze drug delivery technology is based on a proprietary
recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that
locally and temporarily degrades hyaluronan – a glycosaminoglycan
or chain of natural sugars in the body – in the SC space. This
increases the permeability of the tissue under the skin, allowing
space for large molecules like OCREVUS to enter, and enables the SC
formulation to be rapidly dispersed and absorbed into the
bloodstream.
OCREVUS IV is the first and only therapy approved for both 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 PPMS. OCREVUS IV 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.
About the OCARINA II study
OCARINA II (NCT05232825) is a Phase III, global, multicentre,
randomised study evaluating the pharmacokinetics, safety and
radiological and clinical effects of the subcutaneous (SC)
formulation of OCREVUS compared with OCREVUS intravenous (IV)
infusion in 236 patients with relapsing MS (RMS) or primary
progressive MS (PPMS). Initial results shared at ECTRIMS-ACTRIMS
2023 demonstrated that the trial met the primary endpoint of
non-inferiority in area under the serum concentration time curve
(AUC) from day 1 to 12 weeks after SC injection compared to IV
infusion. Secondary endpoints include maximum serum concentration
(Cmax) of OCREVUS, the total number of active, gadolinium-enhancing
T1 lesions at 8 and 12 weeks, and new or enlarging T2 lesions at 12
and 24 weeks, as well as safety and immunogenicity outcomes.
Exploratory endpoints include patient-reported outcomes.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects more than
2.8 million people worldwide. MS occurs when the immune system
abnormally attacks the insulation and support around nerve cells
(myelin sheath) in the central nervous system (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.
People with all forms of MS experience disease progression –
permanent loss of nerve cells in the central nervous system – from
the beginning of their disease even if their clinical symptoms
aren’t apparent or don’t appear to be getting worse. Delays in
diagnosis and treatment can negatively impact people with MS, in
terms of their physical and mental health, and contribute to the
negative financial impact on the individual and society. An
important goal of treating MS is to slow, stop and ideally prevent
disease activity and progression as early as possible.
Relapsing-remitting MS (RRMS) is the most common form of the
disease and is characterised by episodes of new or worsening signs
or symptoms (relapses) followed by periods of recovery.
Approximately 85% 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% 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.
About Roche in Neuroscience
Neuroscience is a major focus of research and development at 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. Roche and Genentech are
investigating more than a dozen medicines for neurological
disorders, including MS, spinal muscular atrophy, neuromyelitis
optica spectrum disorder, Alzheimer’s disease, Huntington’s
disease, Parkinson’s disease, acute ischemic stroke, Duchenne
muscular dystrophy and Angelman syndrome. 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 Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
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.
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