Roche to present new key clinical and real-world data at
ECTRIMS-ACTRIMS 2023 showcasing strength of long-term outcomes in
MS and NMOSD
- Late-breaking results from
Phase III trial of OCREVUS
(ocrelizumab) subcutaneous
injection and Phase II trial of BTK inhibitor
fenebrutinib in multiple sclerosis (MS)
will be presented
- 10-year OCREVUS efficacy
and safety data show significant benefit in slowing long-term
disability progression and consistent long-term
safety profile in MS
- Additional OCREVUS
real-world and clinical data show impact for underrepresented
populations including more than 3,200 pregnant women and Black and
Hispanic/Latinx
patients with MS
- Longer-term safety data and
late-breaking efficacy data from Phase III trial of ENSPRYNG
(satralizumab) in
neuromyelitis optica
spectrum disorder (NMOSD) will be presented
Basel, 02 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will
present new data for OCREVUS® (ocrelizumab) and investigational
Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib for multiple
sclerosis (MS), and ENSPRYNG® (satralizumab) for neuromyelitis
optica spectrum disorder (NMOSD). In total, Roche will be
presenting 36 abstracts at the 9th Joint ECTRIMS-ACTRIMS Meeting
(European and Americas Committees for Treatment and Research in
Multiple Sclerosis) from 11-13 October 2023. Late-breaking data in
MS includes the Phase Ib OCARINA I and Phase III OCARINA II studies
evaluating an investigational subcutaneous OCREVUS injection. In
addition, the Phase II FENopta study of fenebrutinib for people
living with MS and late-breaking ENSPRYNG data for people with
NMOSD, which includes longer-term data from the Phase III
SAkuraMoon study, will also be presented.
“It is gratifying to see that OCREVUS and ENSPRYNG continue to
show a favourable benefit/risk profile over many years in MS and
NMOSD, and we are also pleased to share late-breaking results from
our investigational MS medicine fenebrutinib and OCREVUS
subcutaneous injection,” said Levi Garraway, M.D., Ph.D., Roche’s
Chief Medical Officer and Head of Global Product Development.
“We’ve developed these latest innovations with the goal of further
improving the day-to-day lives of those living with MS.”
Multiple sclerosis (MS)Roche
will present 29 abstracts in MS, including three late-breaking
presentations from the Phase Ib OCARINA I and Phase III OCARINA II
studies on the OCREVUS subcutaneous injection in people with MS and
the Phase II FENopta study of BTK inhibitor fenebrutinib in people
with MS.
Highlights also include 10-year milestone data from the
open-label extensions of Phase III OPERA I and II studies in
relapsing MS (RMS) and ORATORIO study in primary progressive MS
(PPMS) that show benefit on slowing long-term disability
progression. OCREVUS is the only medicine approved for both RMS and
PPMS, and by slowing disability progression it has fundamentally
changed the landscape of MS treatment, with more than 300,000
patients treated globally. Safety outcomes from more than 6,000
patients across 12 OCREVUS clinical trials further support the
medicine’s consistent favourable safety profile over 10 years.
Roche safety data will report pregnancy and infant outcomes from
more than 3,200 pregnancies, and separate real-world data on
pregnant women in the international MSBase registry will provide
insights on the impact of OCREVUS and other disease-modifying
therapies on relapses during and post-pregnancy. Further, one-year
data from the first-ever clinical trial in Black and
Hispanic/Latinx people with MS (Phase IV CHIMES trial) will show
OCREVUS effectively controlled disease activity.
Neuromyelitis optica
spectrum disorder (NMOSD)Roche
will present seven NMOSD abstracts, including late-breaking,
longer-term data from the Phase III SAkuraMoon open-label extension
study and real-world data evaluating ENSPRYNG in people with
NMOSD.
Infection is a major comorbidity in people with NMOSD, and
analyses comparing infection rates across clinical trials,
post-marketing settings and U.S. claims data suggest overall lower
rates in the ENSPRYNG-treated population.
Follow Roche on X via @Roche and keep up to date with
ECTRIMS-ACTRIMS 2023 news and updates by using the hashtag
#MSMilan2023. Below are the details of all Roche presentations.
Medicine |
Abstract title |
Presentation number (type)Presentation
date (session)Time |
|
Regular abstracts available from 01 October at 8:00 CEST.
*Late-breaking abstracts available from 11 October 2023 at 8:00
CEST. |
|
OCREVUS for MS |
Subcutaneous ocrelizumab in patients with multiple sclerosis:
results of the Phase III OCARINA II study |
P370 (poster)11 October (Late Breaking Abstracts*, Poster
Presentation Session 1)16:30 - 18:30 CEST |
|
Subcutaneous ocrelizumab in patients with multiple sclerosis:
results of the Phase Ib dose-finding OCARINA I study |
P371 (poster)11 October (Late Breaking Abstracts*, Poster
Presentation Session 1)16:30 - 18:30 CEST |
|
The patient impact of 10 years of ocrelizumab treatment in multiple
sclerosis: long-term data from the Phase III OPERA and ORATORIO
studies |
P302 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Safety of ocrelizumab in multiple sclerosis: updated analysis in
patients with relapsing and primary progressive multiple
sclerosis |
P304 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Disease activity during pre-conception, pregnancy and postpartum in
women with MS receiving ocrelizumab or other disease-modifying
therapies in a real-world cohort |
O173 (oral)13 October (Scientific Session 20: Female health)12:35 -
12:42 CEST |
|
One-year analysis of efficacy and safety in Black and Hispanic
patients with relapsing multiple sclerosis receiving ocrelizumab
treatment in the CHIMES trial |
P691 (poster)12 October (Poster Presentation Session 2)17:00 -
19:00 CEST |
|
Ocrelizumab dose selection for treatment of paediatric
relapsing-remitting multiple sclerosis: preliminary
pharmacokinetic, safety and efficacy results from the OPERETTA 1
study |
P034 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Pregnancy and infant outcomes in women receiving ocrelizumab for
the treatment of multiple sclerosis: analysis of the largest
available outcome database |
P061 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Cerebrospinal fluid neurofilament heavy levels correlate with
spinal cord lesions and disability in multiple sclerosis |
P241 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Combining measures from clinical assessments, imaging and fluid
biomarkers at one year to predict MS progression at two years |
P258 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Composite confirmed disability worsening is a useful clinical trial
endpoint for multiple sclerosis focusing on disability
progression |
P283 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Reduction of intrathecal immunoglobulin levels with ocrelizumab
treatment in relapsing and primary progressive multiple
sclerosis |
P653 (poster)12 October (Poster Presentation Session 2)17:00 -
19:00 CEST |
|
Low disability accumulation after 4-year ocrelizumab therapy in
treatment-naive patients with early-stage relapsing-remitting
multiple sclerosis; data from the Phase IIIb ENSEMBLE study |
P688 (poster)12 October (Poster Presentation Session 2)17:00 -
19:00 CEST |
|
Persistence to ocrelizumab compared with other disease-modifying
therapies for multiple sclerosis in the German NeuroTransData
registry |
P732 (poster)12 October (Poster Presentation Session 2)17:00 -
19:00 CEST |
|
Utility and implementation of a federated research infrastructure
to assess lack disease stability as a real-world surrogate of PIRA,
by combining MS clinical trial and real-world cohort data (the
INTONATE MS consortium) |
P1181 (e-poster) |
|
Immunological signatures associated with ocrelizumab treatment in
early relapsing-remitting multiple sclerosis (RRMS): new data on T
cell function and pro/anti-inflammatory monocytes of the 12-month
interim analysis from the MA30143 Phase IIIb (ENSEMBLE)
substudy |
P1460 (e-poster) |
|
|
Real-world safety data from up to 4.5 years of ocrelizumab in
relapsing and primary progressive multiple sclerosis - a CONFIDENCE
interim analysis |
P333 (e-poster) |
|
|
Real-world effectiveness of ocrelizumab in patients with primary
progressive multiple sclerosis grouped by EDSS at baseline – a
CONFIDENCE study interim analysis |
P336 (e-poster) |
|
|
Specific unmet medical needs in the care of patients with relapsing
multiple sclerosis: final results from the PROFILE RMS study |
P738 (eposter) |
|
|
|
Disease-related knowledge and patient perceptions in
relapsing-remitting multiple sclerosis |
P1189 (e-poster) |
|
MS patients treated with ocrelizumab using BRISA - an MS specific
app in Germany |
P1594 (e-poster) |
|
Ocrelizumab safety under real-world conditions: Contrasting
investigator-reported safety with patient-reported safety in people
with multiple sclerosis (CONFIDENCE, COMPASS and TrotzMS) |
P334 (e-poster) |
|
|
Development of a self-assessment tool for the autonomy of patients
with multiple sclerosis (ms) |
P1190 (e-poster) |
|
Implications of progression independent of relapse activity (PIRA)
for multiple sclerosis clinical trials: item banks could provide
the precise patient-reported outcome measures needed |
P478 (e-poster) |
|
Unsupervised analysis reveals that memory IgA B cells are spared by
ocrelizumab treatment |
P762 (e-poster)11 October (Late Breaking Abstracts*, Poster
Presentation Session 1)16:30 - 18:30 CEST |
|
Drug combination discovery for treatment of Multiple Sclerosis
using machine learning |
P790 (poster)11 October (Late Breaking Abstracts*, Poster
Presentation Session 1)16:30 - 18:30 CEST |
|
Fenebrutinib for MS |
Cerebrospinal fluid and MRI analyses of fenebrutinib treatment in
multiple sclerosis reveal brain penetration and early reduction of
new lesion activity: results from the Phase II FENopta study |
O187 (oral)13 October (Scientific Session 22: Late Breaking
Abstracts*)16:03 - 16:10 CEST |
|
Fenebrutinib, a noncovalent, reversible, Bruton's tyrosine kinase
inhibitor, potently blocks neuroinflammation induced by Fcy
receptor activation in human microglial systems: implications for
multiple sclerosis treatment |
P686 (poster)12 October (Poster Presentation Session 2)17:00 -
19:00 CEST |
|
Floodlight™ in MS |
Smartphone-based passive monitoring of gait in people with
progressive multiple sclerosis |
P100 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
ENSPRYNG for NMOSD |
Long-term efficacy of satralizumab in patients with AQP4-IgG+
NMOSD: updated analysis from the open-label SAkuraMoon study |
P362 (poster)11 October (Late Breaking Abstracts*, Poster
Presentation Session 1)16:30 - 18:30 CEST |
|
Infection in NMOSD: an analysis of the patterns of infection in
SAkuraMoon (an open-label study to evaluate the long-term safety
and efficacy of satralizumab) with post-marketing data and US-based
health claims data |
P301 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Clarification of blood-retinal barrier on AQP4-peptide immunized
mice |
P115 (poster)11 October (Poster Presentation Session 1)16:30 -
18:30 CEST |
|
Addressing the burdens of neuromyelitis optica spectrum disorder
amid challenges of the COVID-19 pandemic: real-world perspectives
from patients |
P1014 (e-poster) |
|
Satralizumab treatment in adults with AQP4-IgG-seropositive
neuromyelitis optica spectrum disorder: a retrospective case
series |
P1036 (e-poster) |
|
Relapse under the prescription of satralizumab in neuromyelitis
optica spectrum disorder: analysis of a Japanese claims
database |
P1557 (e-poster) |
|
Use of immunosuppressive therapy among patients with NMOSD using
satralizumab treatment: a study based on Japanese real-world
data |
P1574 (e-poster) |
|
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 OCREVUS
(ocrelizumab)OCREVUS is
the first and only therapy approved for both RMS (including RRMS
and active, or relapsing SPMS, in addition to clinically isolated
syndrome [CIS] in the U.S.) and PPMS. 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. OCREVUS 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 fenebrutinibFenebrutinib
is an investigational oral, reversible and non-covalent Bruton’s
tyrosine kinase (BTK) inhibitor that blocks the function of BTK.
BTK, also known as tyrosine-protein kinase BTK, is an enzyme that
regulates B-cell development and activation and is also involved in
the activation of innate immune system myeloid lineage cells, such
as macrophages and microglia. Pre-clinical data have shown
fenebrutinib to be potent and highly selective, and it is the only
reversible inhibitor currently in Phase III trials for MS.
Fenebrutinib has been shown to be 130 times more selective for BTK
vs. other kinases. These design features may be important as the
high selectivity and reversibility can potentially reduce
off-target effects of a molecule.
Fenebrutinib is a dual inhibitor of both B-cell and microglia
activation. This dual inhibition may be able to reduce both MS
disease activity and progression, thereby potentially addressing
the key unmet medical need in people living with MS. The Phase III
programme includes two identical trials in RMS (FENhance 1 & 2)
with an active teriflunomide comparator and one trial in primary
progressive MS (PPMS) (FENtrepid) in which fenebrutinib is being
evaluated against OCREVUS® (ocrelizumab). To date, more than 2,500
patients and healthy volunteers have been treated with fenebrutinib
in Phase I, II and III clinical programmes across multiple
diseases, including MS and other autoimmune disorders.
About ENSPRYNG
(satralizumab)ENSPRYNG,
which was designed by Chugai, a member of the Roche Group, is a
humanised monoclonal antibody that targets interleukin-6 (IL-6)
receptor activity. ENSPRYNG was designed using novel recycling
antibody technology which, compared to conventional technology,
allows for longer duration of the antibody and subcutaneous dosing
every four weeks.
Positive Phase III results for ENSPRYNG, as both monotherapy and
in combination with baseline immunosuppressive therapy, demonstrate
that IL-6 inhibition is an effective therapeutic approach for
neuromyelitis optica spectrum disorder (NMOSD). ENSPRYNG is
currently approved for NMOSD in 85 countries with further
applications under review with numerous regulators. Roche continues
to investigate ENSPRYNG in other autoantibody-mediated rare
neurological diseases characterised by elevated IL-6 levels,
indications including generalised Myasthenia Gravis (gMG), Myelin
Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)
and Autoimmune Encephalitis (AIE).
ENSPRYNG was granted Breakthrough Therapy Designation for the
treatment of NMOSD by the FDA in December 2018 and designated as an
orphan drug for NMOSD in the United States, Europe, Russia and
Japan.
In addition,the FDA has designated satralizumab as an
investigational orphan drug for gMG, MOGAD and AIE (NMDAR).
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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