Roche’s OCREVUS twice-yearly, 10-minute subcutaneous injection was
non-inferior to intravenous infusion and provided near-complete
suppression of brain lesions
- Late-breaking Phase III
results show subcutaneous injection was non-inferior to intravenous
infusion based on OCREVUS levels in the blood over 12
weeks
- OCREVUS subcutaneous
injection was comparable to IV infusion in providing rapid and
sustained depletion of B cells and near-complete suppression of MRI
lesion activity in the brain over 24 weeks
- The safety profile of
OCREVUS subcutaneous injection was consistent with the
well-established safety profile of OCREVUS IV
infusion
- The 10-minute subcutaneous
injection has potential to improve the treatment experience and
expand usage for people with multiple sclerosis (MS) in centres
with IV capacity limitations
Basel, 11 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced late-breaking data from the Phase III OCARINA II
study. Study results demonstrate the effect of OCREVUS®
(ocrelizumab) as an investigational twice-yearly, 10-minute
subcutaneous injection on pharmacokinetic, biomarker, and MRI
measures in patients with relapsing or primary progressive multiple
sclerosis (RMS or PPMS). The data will be presented in a poster at
the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas
Committees for Treatment and Research in Multiple Sclerosis).
“We are pleased to share that OCREVUS 10-minute subcutaneous
injection suppressed brain lesions as effectively as the
intravenous infusion,” said Levi Garraway, M.D., Ph.D., Roche’s
Chief Medical Officer and Head of Global Product Development.
“Having this additional treatment option may improve the treatment
experience for both patients and physicians, and we hope the
twice-a-year dosing will offer the same high adherence and
persistence.’’
OCREVUS subcutaneous injection was non-inferior to OCREVUS IV
infusion as measured by OCREVUS levels in the blood of patients
(area under the serum concentration time curve) from day 1 to 12
weeks (3500 day*µg/mL for subcutaneous injection vs. 2750 day*µg/mL
for IV infusion). Peak OCREVUS blood (serum) concentrations were
similar for subcutaneous injection (132 µg/mL) and IV infusion (137
µg/mL).
OCREVUS subcutaneous injection provided rapid, sustained and
near-complete B-cell depletion that was similar to OCREVUS IV
infusion (97% and 98% of patients respectively had B cells levels
of 5 cells/µL or less when first measured at 14 days), which was
sustained over 24 weeks. At the time of analysis, approximately
half the patients in the study had reached 24 weeks of
treatment.
Both OCREVUS subcutaneous injection and OCREVUS IV infusion
resulted in rapid and near-complete suppression of MRI lesion
activity by 24 weeks, with most patients having no T1
gadolinium-enhancing (T1-Gd+) lesions, which are markers of active
inflammation, and no new/enlarging T2 lesions, which represent the
amount of disease burden or lesion load at 24 weeks.
|
T1-Gd+ lesions |
New/enlarging T2 lesions |
|
Average lesion number |
Adjusted lesion rate |
Average lesion number |
Adjusted lesion rate |
|
Baseline |
8 weeks |
24 weeks |
Baseline |
12 weeks |
24 weeks |
OCREVUS subcutaneous injection |
0.54 |
0.11 |
0.00 |
44.48 |
0.04 |
0.00 |
OCREVUS IV |
0.98 |
0.12 |
0.00 |
49.84 |
0.05 |
0.00 |
The safety profile of OCREVUS subcutaneous injection was
consistent with the well-established safety profile of OCREVUS IV
infusion. No new safety signals were identified for OCREVUS
subcutaneous injection. The most common adverse events in the
OCREVUS subcutaneous injection group were injection reactions (48%
of all exposed patients), all of which were either mild or
moderate. The most common AEs in the OCREVUS IV infusion group were
infusion-related reactions (17%). A total of 4 and 7 serious AEs
were experienced by 3 (2.5%) and 4 (3.4%) patients in the OCREVUS
subcutaneous and IV infusion groups, respectively.
The OCREVUS twice-yearly, 10-minute subcutaneous injection is
healthcare provider administered and designed to be delivered
without the need for IV infrastructure, so it has the potential to
expand the usage of OCREVUS in treatment centres without IV
infrastructure or those with IV capacity limitations. This provides
an additional delivery option so that OCREVUS can be matched to the
individual needs of people with MS and healthcare
professionals.
The OCARINA II data will be submitted to health authorities
around the world in the coming months. Roche is committed to
advancing innovative clinical research programmes to broaden the
scientific understanding of MS, further reduce disability
progression in RMS and PPMS and improve the treatment experiences
for those living with the disease.
About the subcutaneous formulation of OCREVUS
(ocrelizumab)The investigational subcutaneous 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 subcutaneous space.
This increases the permeability of the tissue under the skin,
allowing space for large molecules like OCREVUS to enter, and
enables the subcutaneous 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 studyOCARINA II is a Phase
III, global, multicentre, randomised study evaluating the
pharmacokinetics, safety and radiological and clinical effects of
the subcutaneous formulation of OCREVUS compared with OCREVUS
intravenous (IV) infusion in 236 patients with relapsing MS (RMS)
or primary progressive MS (PPMS). The primary endpoint is
non-inferiority in area under the serum concentration time curve
(AUC) from day 1 to 12 weeks after subcutaneous 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 sclerosisMultiple 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 NeuroscienceNeuroscience 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 thirteenth 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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- 11102023_MR_Ocrevus SC Data_en
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