· Data show superiority of OCREVUS compared to Rebif (interferon beta-1a)
in significantly reducing disability Progression Independent of Relapse
Activity (PIRA) in people with relapsing multiple sclerosis (RMS)
· Data demonstrates first method to automatically detect and characterize
Slowly Evolving Lesions (SELs) as a potential measure of underlying disease
activity in the brain using MRI
· New results from FLOODLIGHT study suggest smartphone-based disease
progression monitoring can augment in-clinic tests, such as hand/arm function
and walking behavior
South San Francisco, CA — October 26, 2017 —
Genentech,
a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that
new OCREVUS® (ocrelizumab) data are being presented at the 7th Joint
European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) –
Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)
Meeting in Paris, France. The data presented showcase clinical advances around
underlying disease activity and disability progression in relapsing and
progressive forms of multiple sclerosis (MS), through the exploration of newly
emerging endpoints and precision monitoring.
a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that
new OCREVUS® (ocrelizumab) data are being presented at the 7th Joint
European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) –
Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)
Meeting in Paris, France. The data presented showcase clinical advances around
underlying disease activity and disability progression in relapsing and
progressive forms of multiple sclerosis (MS), through the exploration of newly
emerging endpoints and precision monitoring.
OCREVUS
significantly reduced the proportion of people with RMS who experienced
Progression Independent of Relapse Activity (PIRA) in a post-hoc analysis
compared to Rebif® (interferon-beta 1a). This effect was particularly seen
in those who were potentially at higher risk of progressive disease course
based on their baseline Expanded Disability Status Scale (EDSS). Specifically,
in this analysis, OCREVUS treatment reduced the risk of PIRA by 25 percent and
23 percent confirmed at 12 and 24 weeks, respectively (p=0.008 and p=0.039,
respectively).
significantly reduced the proportion of people with RMS who experienced
Progression Independent of Relapse Activity (PIRA) in a post-hoc analysis
compared to Rebif® (interferon-beta 1a). This effect was particularly seen
in those who were potentially at higher risk of progressive disease course
based on their baseline Expanded Disability Status Scale (EDSS). Specifically,
in this analysis, OCREVUS treatment reduced the risk of PIRA by 25 percent and
23 percent confirmed at 12 and 24 weeks, respectively (p=0.008 and p=0.039,
respectively).
PIRA
is a newly emerging MS endpoint intended to measure an increase in disability,
which is related to underlying disease activity in RMS. These data were
generated through a post-hoc analysis of more than 1,600 people randomly
assigned to treatment in OPERA I and OPERA II, and assessed for PIRA, as
measured by cCDP. cCDP is a measure of the risk of a person’s physical
disability getting worse and is based on three measures of physical disability
– confirmed disability progression, walking speed and upper extremity function.
is a newly emerging MS endpoint intended to measure an increase in disability,
which is related to underlying disease activity in RMS. These data were
generated through a post-hoc analysis of more than 1,600 people randomly
assigned to treatment in OPERA I and OPERA II, and assessed for PIRA, as
measured by cCDP. cCDP is a measure of the risk of a person’s physical
disability getting worse and is based on three measures of physical disability
– confirmed disability progression, walking speed and upper extremity function.
“These
new analyses of data from the large controlled studies with OCREVUS help
advance our understanding of how, in relapsing MS, the disease may progress independent
of relapses. These insights have implications for daily decisions made together
with patients,” said Ludwig Kappos, M.D., chair of the Department of Neurology,
University Hospital, Basel, Switzerland. “Even without experiencing relapses,
people with RMS may still have underlying disease activity, which can cause
irreversible decline in their mobility and day-to-day quality of life.
Recognizing and understanding this process supports early indication of more
efficacious treatment.”
new analyses of data from the large controlled studies with OCREVUS help
advance our understanding of how, in relapsing MS, the disease may progress independent
of relapses. These insights have implications for daily decisions made together
with patients,” said Ludwig Kappos, M.D., chair of the Department of Neurology,
University Hospital, Basel, Switzerland. “Even without experiencing relapses,
people with RMS may still have underlying disease activity, which can cause
irreversible decline in their mobility and day-to-day quality of life.
Recognizing and understanding this process supports early indication of more
efficacious treatment.”
A
platform presentation, also highlighting underlying disease activity, showed
that a new algorithm using conventional MRI can be used as a possible biomarker
to automatically detect Slowly Evolving Lesions (SELs), as a potential measure
of chronic disease activity outside of acute lesions in the brain. SELs were
shown to evolve independently of acute lesions leading to enhanced focal brain
tissue loss, as measured by T1 black hole evolution. Further research is
needed, but this algorithm for automatic detection of SELs using conventional
brain MRI may provide a marker of chronic disease activity in MS lesions.
platform presentation, also highlighting underlying disease activity, showed
that a new algorithm using conventional MRI can be used as a possible biomarker
to automatically detect Slowly Evolving Lesions (SELs), as a potential measure
of chronic disease activity outside of acute lesions in the brain. SELs were
shown to evolve independently of acute lesions leading to enhanced focal brain
tissue loss, as measured by T1 black hole evolution. Further research is
needed, but this algorithm for automatic detection of SELs using conventional
brain MRI may provide a marker of chronic disease activity in MS lesions.
“This
new ability to detect both acute and underlying disease activity with
conventional MRI may advance the way we monitor for MS progression and how we
think about overall patient management,” said Stephen Hauser, M.D., chair of
the Scientific Steering Committee of the OPERA studies, director of the Weill
Institute for Neurosciences and chair of the Department of Neurology at the
University of California, San Francisco. “While we’ve seen SELs can occur
across MS subtypes, this finding may be particularly promising for people with
primary progressive MS whose worsening of disability may be related to the
presence of SELs. This study also highlights the importance of continued
research in MS, not only for development of new treatments such as OCREVUS, but
for the insights that are gained about the fundamental cause of this
debilitating disease.”
new ability to detect both acute and underlying disease activity with
conventional MRI may advance the way we monitor for MS progression and how we
think about overall patient management,” said Stephen Hauser, M.D., chair of
the Scientific Steering Committee of the OPERA studies, director of the Weill
Institute for Neurosciences and chair of the Department of Neurology at the
University of California, San Francisco. “While we’ve seen SELs can occur
across MS subtypes, this finding may be particularly promising for people with
primary progressive MS whose worsening of disability may be related to the
presence of SELs. This study also highlights the importance of continued
research in MS, not only for development of new treatments such as OCREVUS, but
for the insights that are gained about the fundamental cause of this
debilitating disease.”
New
data from the FLOODLIGHT clinical trial program, which is designed to assess
sensor-based outcomes from a series of active neurological tests and passive
monitoring through the use of a smartphone is also being presented. The tool
enables a continuous stream of precise, real-world MS disease progression data
to be collected and analyzed using dedicated algorithms and machine learning.
data from the FLOODLIGHT clinical trial program, which is designed to assess
sensor-based outcomes from a series of active neurological tests and passive
monitoring through the use of a smartphone is also being presented. The tool
enables a continuous stream of precise, real-world MS disease progression data
to be collected and analyzed using dedicated algorithms and machine learning.
Data
at ECTRIMS – ACTRIMS demonstrate strong patient adherence to the FLOODLIGHT
technology. Hand/arm function measured with a smartphone-based pinching test
may detect subclinical impairment in those who have normal Nine-Hole Peg Test
(9-HPT) performances. Turning speed measured with a smartphone-based U-Turn
Test was shown to correlate with the Timed 25-Foot Walk (T25-FW) (p<0.001),
and may detect subclinical activity compared to normal in-clinic performances.
The data support FLOODLIGHT as a potential complement to in-clinic testing to
provide a more complete and consistent picture of a patient’s disease
progression.
at ECTRIMS – ACTRIMS demonstrate strong patient adherence to the FLOODLIGHT
technology. Hand/arm function measured with a smartphone-based pinching test
may detect subclinical impairment in those who have normal Nine-Hole Peg Test
(9-HPT) performances. Turning speed measured with a smartphone-based U-Turn
Test was shown to correlate with the Timed 25-Foot Walk (T25-FW) (p<0.001),
and may detect subclinical activity compared to normal in-clinic performances.
The data support FLOODLIGHT as a potential complement to in-clinic testing to
provide a more complete and consistent picture of a patient’s disease
progression.
Additionally,
OPERA I, OPERA II and ORATORIO Phase III open-label extension data presented at
ECTRIMS – ACTRIMS continue to show a favorable benefit-risk profile for
OCREVUS.
OPERA I, OPERA II and ORATORIO Phase III open-label extension data presented at
ECTRIMS – ACTRIMS continue to show a favorable benefit-risk profile for
OCREVUS.
OCREVUS
has been approved for use in countries across North America, South America, the
Middle East, Eastern Europe, as well as in Australia and Switzerland.
has been approved for use in countries across North America, South America, the
Middle East, Eastern Europe, as well as in Australia and Switzerland.
Follow
Genentech on Twitter via @Genentech and keep up to date with Joint ECTRIMS –
ACTRIMS Meeting news and updates by using the hashtag #MSParis2017.
Genentech on Twitter via @Genentech and keep up to date with Joint ECTRIMS –
ACTRIMS Meeting news and updates by using the hashtag #MSParis2017.
About the OPERA I and OPERA II studies in relapsing forms of MS
OPERA
I and OPERA II are Phase III, randomized, double-blind, double-dummy, global
multi-center studies evaluating the efficacy and safety of OCREVUS (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. In these studies, relapsing MS (RMS)
was defined as relapsing-remitting MS (RRMS) and secondary progressive MS
(SPMS) with relapses. A similar proportion of patients in the OCREVUS group
experienced serious adverse events and serious infections compared with
patients in the high-dose interferon beta-1a group in the RMS studies.
I and OPERA II are Phase III, randomized, double-blind, double-dummy, global
multi-center studies evaluating the efficacy and safety of OCREVUS (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. In these studies, relapsing MS (RMS)
was defined as relapsing-remitting MS (RRMS) and secondary progressive MS
(SPMS) with relapses. A similar proportion of patients in the OCREVUS group
experienced serious adverse events and serious infections compared with
patients in the high-dose interferon beta-1a group in the RMS studies.
About the ORATORIO study in primary progressive MS
ORATORIO
is a Phase III, randomized, double-blind, global multi-center study evaluating
the efficacy and safety of OCREVUS (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). The blinded treatment
period of the ORATORIO study continued until all patients had received at least
120 weeks of either OCREVUS or placebo and a predefined number of confirmed
disability progression (CDP) events was reached overall in the study. A similar
proportion of patients in the OCREVUS group experienced adverse events and
serious adverse events compared with patients in the placebo group in the PPMS
study.
is a Phase III, randomized, double-blind, global multi-center study evaluating
the efficacy and safety of OCREVUS (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). The blinded treatment
period of the ORATORIO study continued until all patients had received at least
120 weeks of either OCREVUS or placebo and a predefined number of confirmed
disability progression (CDP) events was reached overall in the study. A similar
proportion of patients in the OCREVUS group experienced adverse events and
serious adverse events compared with patients in the placebo group in the PPMS
study.
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