DARMSTADT, Germany-Thursday 24 February 2022 [ AETOS Wire ]
New real-world data show MAVENCLAD® (cladribine tablets) had lower
annualised relapse rates and longer time to first relapse and time to
switch than fingolimod, dimethyl fumarate and teriflunomide in relapsing
multiple sclerosis patients
Additional clinical trial data show
patients treated with MAVENCLAD early after a first clinical
demyelinating event had a lower occurrence of further relapses or
disability progression as compared to placebo
Not intended for UK and U.S. based media
(BUSINESS
WIRE) -- Merck, a leading science and technology company, today
announced new real-world data from the MSBase Registry demonstrating
MAVENCLAD® (cladribine tablets) had more favourable relapse outcomes and
longer time to switch to another disease modifying therapy (DMT)
compared to the oral DMTs fingolimod, dimethyl fumarate (DMF) and
teriflunomide in relapsing multiple sclerosis (RMS) patients. A second
study, analysing real-world follow up of clinical trial patients with a
first attack suggestive of MS, showed those treated with MAVENCLAD had a
lower rate of conversion to clinically definite multiple sclerosis
(CDMS), defined by further relapse or disability progression, and lower
risk of relapse than those not exposed to MAVENCLAD. These data will be
presented at the Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) Forum 2022, taking place 24-26 February
2022.
In this first analysis of its size from the Generating
Learnings In MultiPle SclErosis (GLIMPSE) study, data from 633 patients
prescribed MAVENCLAD in the MSBase Registry was matched using propensity
scores to patients receiving fingolimod (n=1195), DMF (n=912) or
teriflunomide (n=735). Results showed the annualised relapse rate (ARR)
for patients treated with MAVENCLAD was 0.09 compared to 0.15, 0.15 and
0.17 for fingolimod, DMF and teriflunomide, respectively. Time-to-first
relapse in MAVENCLAD-treated patients was 40%, 42% and 67% lower than in
patients treated with fingolimod, DMF and teriflunomide, respectively.
The time to switch rate in patients treated with MAVENCLAD was 4, 7 and
6.5 times lower than fingolimod, DMF and teriflunomide, respectively.
The GLIMPSE study was a longitudinal, retrospective analysis of adult
patients identified with RMS from the MSBase Registry, an international
online registry for neurologists studying MS and other
neuro-immunological diseases.
“It is important in a lifelong
disease like MS to continue assessing the efficacy and safety of
available treatment options in the real world,” said Helmut Butzkueven,
MBBS, FRACP, PhD, Department of Neuroscience, Central Clinical School,
Monash University, Melbourne. “This is where the MSBase Registry, using
standardised data records from over 79,000 people with MS around the
world, can provide information that is not possible to obtain in a
randomised clinical trial. This information showed us that in GLIMPSE,
MAVENCLAD had better relapse outcomes and longer treatment persistence
compared to other oral DMTs, including fingolimod.”
Also being
presented are new data from an exploratory Phase IV CLASSIC-MS follow-up
of patients (n=227) from the Phase III ORACLE-MS study which suggest
early use of cladribine tablets reduced the risk of further relapse or
disability progression (CDMS) in patients who experienced a first
episode of neurologic attack with characteristics that put them at high
risk of CDMS. Over half the patients (53.2%) treated with cladribine
tablets remained relapse free compared to 28.2% of those who did not
receive cladribine tablets. In patients who received cladribine tablets,
42.9% were diagnosed with CDMS in the median of 9.5 years since their
last dose. In patients never treated with cladribine tablets, 70.4% were
diagnosed with CDMS.
In ORACLE-MS, patients with a first
clinical demyelinating event were randomised to receive cladribine
tablets 3.5 mg/kg, cladribine tablets 5.25 mg/kg or placebo. This
analysis at the ACTRIMS Forum 2022 investigated the long-term efficacy
in patients from the ORACLE-MS trial who had received at least one
course of cladribine tablets (68.7%) or placebo (31.3%). Cladribine
tablets (5.25 mg/kg) are not approved for any use in any region.
About MAVENCLAD®
MAVENCLAD®
is a short-course oral therapy that selectively and periodically
targets lymphocytes thought to be integral to the pathological process
of relapsing MS (RMS). In August 2017, the European Commission (EC)
granted marketing authorization for MAVENCLAD® for the treatment of
relapsing forms of multiple sclerosis (RMS) in the 28 countries of the
European Union (EU) in addition to Norway, Liechtenstein and Iceland.
MAVENCLAD® has since then been approved in over 80 countries, including
Canada, Australia and the U.S. Refer to the respective prescribing
information for further details.
The clinical development programme for cladribine tablets includes:
The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year
Phase III placebo-controlled study designed to evaluate the efficacy and
safety of cladribine tablets as a monotherapy in patients with RRMS.
The CLARITY extension study: a Phase III placebo-controlled study
following on from the CLARITY study, which evaluated the safety and
exploratory efficacy of cladribine tablets over two additional years
beyond the two-year CLARITY study, according to the treatment assignment
scheme for years 3 and 4.
The ORACLE MS (Oral Cladribine in
Early MS) study: a two-year Phase III placebo-controlled study designed
to evaluate the efficacy and safety of cladribine tablets as a
monotherapy in patients at risk of developing MS (patients who have
experienced a first clinical event suggestive of MS).
The
ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With
Active Relapsing Disease) study: a Phase II placebo-controlled study
designed primarily to evaluate the safety and tolerability of adding
cladribine tablets treatment to patients with relapsing forms of MS, who
have experienced breakthrough disease while on established
interferon-beta therapy.
PREMIERE (Prospective Observational
Long-term Safety Registry of Multiple Sclerosis) study: a long-term
observational follow-up safety registry of MS patients who participated
in cladribine tablets clinical studies.
In the two-year CLARITY
study, the most commonly reported adverse event (AE) in patients treated
with cladribine tablets was lymphopenia (26.7% with cladribine tablets
and 1.8% for placebo). The incidence of infections was 48.3% with
cladribine tablets and 42.5% with placebo, with 99.1% and 99.0%
respectively rated mild-to-moderate by investigators. Adverse Events
reported in other clinical studies were similar.
About Multiple Sclerosis
Multiple
sclerosis (MS) is a chronic, inflammatory condition of the central
nervous system and is the most common non-traumatic, disabling
neurological disease in young adults. It is estimated that approximately
2.8 million people have MS worldwide. While symptoms can vary, the most
common symptoms of MS include blurred vision, numbness or tingling in
the limbs and problems with strength and coordination. The relapsing
forms of MS are the most common.
Merck in Neurology and Immunology
Merck
has a long-standing legacy in neurology and immunology, with
significant R&D and commercial experience in multiple sclerosis
(MS). The company`s current MS portfolio includes two products for the
treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD®
(cladribine tablets). Merck aims to improve the lives of patients by
addressing areas of unmet medical needs. In addition to Merck`s
commitment to MS, the company also has a pipeline focusing on
discovering new therapies that have the potential in other
neuroinflammatory and immune-mediated diseases, including systemic lupus
erythematosus (SLE).
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About Merck
Merck,
a leading science and technology company, operates across healthcare,
life science and electronics. Around 58,000 employees work to make a
positive difference to millions of people’s lives every day by creating
more joyful and sustainable ways to live. From advancing gene-editing
technologies and discovering unique ways to treat the most challenging
diseases to enabling the intelligence of devices – the company is
everywhere. In 2020, Merck generated sales of € 17.5 billion in 66
countries.
Scientific exploration and responsible
entrepreneurship have been key to Merck’s technological and scientific
advances. This is how Merck has thrived since its founding in 1668. The
founding family remains the majority owner of the publicly listed
company. Merck holds the global rights to the Merck name and brand. The
only exceptions are the United States and Canada, where the business
sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in
life science and EMD Electronics.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220223006102/en/
Contacts
Geoffrey Vokes
geoffrey.vokes@merckgroup.com
+31 6 51 42 10 99
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