[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update
on Phase III GRADUATE programme evaluating gantenerumab in early
Alzheimer’s disease
- Phase III GRADUATE studies did not meet their primary
endpoints of slowing clinical decline in people with early
Alzheimer’s
- The level of beta-amyloid removal by
gantenerumab was lower than
expected
- Topline data will be presented at the Clinical Trials
on Alzheimer’s Disease (CTAD) Conference
- Roche is committed to the Alzheimer’s community and
will continue to develop novel diagnostics and
potential treatments for Alzheimer’s
Basel, 14 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced results from the GRADUATE I and II studies
evaluating gantenerumab in people with mild cognitive impairment
(MCI) due to Alzheimer’s and mild Alzheimer’s dementia,
collectively called early Alzheimer’s disease. The studies did not
meet their primary endpoint of slowing clinical decline.
Gantenerumab was well tolerated, including the subcutaneous
administration.
“So many of our families have been directly affected by
Alzheimer’s, so this news is very disappointing to deliver,” said
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head
of Global Product Development. “We are profoundly grateful to the
study participants, their care partners and study sites for their
contributions to this research. While the GRADUATE results are not
what we hoped, we are proud to have delivered a high quality, clear
and comprehensive Alzheimer’s dataset to the field, and we look
forward to sharing our learnings with the community as we continue
to search for new treatments for this complex disease.”
Study participants treated with gantenerumab showed a slowing of
clinical decline in GRADUATE I and GRADUATE II of -0.31 (p=0.0954),
and -0.19 (p=0.2998) respectively from baseline score on the
Clinical Dementia Rating-Sum of Boxes (CDR-SB), however, neither
was statistically significant. This represents a relative reduction
in clinical decline of 8% in GRADUATE I and 6% in GRADUATE II
compared with placebo. The CDR-SB measures cognitive and functional
change across six areas including memory, orientation, judgement
and problem solving, community affairs, home and hobbies, and
personal care.
The level of beta-amyloid removal, the protein that builds up to
make plaques in the brains of people with Alzheimer's disease, was
lower than expected. Roche will present topline findings of the
GRADUATE I and II studies at the upcoming Clinical Trials on
Alzheimer’s Disease (CTAD) Conference on Wednesday, 30 November,
2022 at 16:15 PT.
Amyloid related imaging abnormalities (ARIA) are a common
radiological finding associated with amyloid-targeting therapies.
The incidence of ARIA-E (oedema or effusion) in the pooled
gantenerumab arms was 25%, with the vast majority being
asymptomatic and very few leading to treatment discontinuation. The
incidence of isolated ARIA-H (haemosiderin) was balanced across the
gantenerumab and placebo groups.
Roche remains committed to Alzheimer’s disease, one of the most
complex neurological disorders and a major public health challenge.
The company is continuing to develop and deliver tests to enable
early and accurate Alzheimer’s diagnosis and has a pipeline of
investigational medicines for different targets, types and stages
of the disease.
About the GRADUATE I and II studiesThe Phase
III GRADUATE I and II studies were two global, double-blind,
randomised, placebo-controlled clinical trials evaluating the
safety and efficacy of the investigational anti-amyloid monoclonal
antibody gantenerumab in people with mild cognitive impairment
(MCI) due to Alzheimer’s and mild Alzheimer’s dementia over 27
months. 1,965 study participants across 30 countries were
randomised 1:1 to receive gantenerumab or placebo by subcutaneous
injection titrated to reach a target dose of 510 mg administered
every two weeks. The primary endpoint was the change from baseline
on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 116 weeks.
The CDR-SB measures cognitive and functional change across six
areas including memory, orientation, judgement and problem solving,
community affairs, home and hobbies, and personal care. There were
17 secondary endpoints including change in disease severity
assessed using various neuropsychological and functional assessment
tools (e.g., MMSE, ADAS-Cog, etc.), assessment of therapeutic
levels of gantenerumab, incidence of adverse events, disease
biomarkers and scans. A full list is available at
clinicaltrials.gov.
About gantenerumabGantenerumab
is a fully-human monoclonal IgG1 antibody, an investigational
medicine that is subcutaneously administered and designed to target
and bind to aggregated forms of beta-amyloid, including oligomers,
fibrils and plaques, and activate immune cells in the brain
(microglia) to clear amyloid plaques and prevent further
accumulation. Gantenerumab was discovered in collaboration with
MorphoSys.
About Roche in Alzheimer’s diseaseWith more
than two decades of scientific research in Alzheimer’s, Roche is
working towards a day when we can detect the disease early and stop
its progression to preserve what makes people who they are. Today,
the company’s Alzheimer’s portfolio spans investigational medicines
for different targets, types and stages of the disease. It also
includes approved and investigational tools, including digital and
blood-based tests and cerebrospinal fluid (CSF) assays, aiming to
more effectively detect, diagnose, and monitor the disease. Yet the
global challenges of Alzheimer’s go well beyond the capabilities of
science, and making a meaningful impact requires collaboration both
within the Alzheimer’s community and outside of healthcare. We will
continue to work together with numerous partners with the hope we
can transform millions of lives.
About Roche in
neuroscienceNeuroscience is a major focus of
research and development at Roche. Our goal is to pursue
groundbreaking science to develop new treatments that help improve
the lives of people with chronic and potentially devastating
diseases.
Roche has both approved and investigational medicines across
multiple sclerosis, spinal muscular atrophy, neuromyelitis optica
spectrum disorder, myasthenia gravis, Alzheimer’s disease,
Huntington’s disease, Parkinson’s disease and Duchenne muscular
dystrophy. Together with our partners, we are committed to pushing
the boundaries of scientific understanding to solve some of the
most difficult challenges in neuroscience. 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 endeavor 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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