Merck to Present New Data on MS Portfolio: Rebif, Mavenclad, and Evobrutinib at ECTRIMS 2017
DARMSTADT, Germany, Oct. 18, 2017 /PRNewswire/ --
Not intended for US/UK based media
Merck, a leading science and technology company, today announced that data for approved and investigational multiple sclerosis (MS) treatments, MAVENCLAD(®) (Cladribine Tablets) and Rebif(®) (interferon beta-1a) and evobrutinib will be presented at MSParis 2017, 7(th) Joint ECTRIMS-ACTRIMS Meeting, 25-28 October 2017 in Paris, France. Efficacy data will be presented from the CLARITY, CLARITY Extension and ORACLE-MS trials which highlight that MAVENCLAD(®) delivers and sustains 4 years of disease control with a maximum of 20 days of oral treatment in the first 2 years. Additional safety analysis assessing malignancy and infection risk will be presented along with data for MAVENCLAD(® )which further detail how the treatment is thought to selectively target the adaptive immune system.
Data presentations for Rebif(®) will focus on long-term disease activity assessed by the MAGNIMS (Magnetic Resonance Imaging in MS) score. Real-world evidence presentations will evaluate relapse rates in patients newly initiating on Rebif(®), and an assessment of treatment adherence rates for patients treated with Rebif(®) compared with dimethyl fumarate.
Furthermore, key preclinical data will be presented for Merck's investigational evobrutinib (M2951), a Bruton's tyrosine kinase (BTK) inhibitor, which is thought to be important in the development and functioning of various immune cells including B lymphocytes, specifically in patients with MS.
"The breadth of data being presented at this year's congress underpin Merck's commitment to deepening the understanding of how our portfolio of products, whether approved or investigational, target MS, and reinforce our dedication to provide differentiated treatment options to physicians and people living with MS," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck.
In addition to data presentations, two Merck-sponsored symposia will take place during the meeting:
-- Balancing benefits and risks of DMDs in MS, Thursday, October 26,
18:00-19:00, Hall A
-- Potential solutions to treatment burden in MS, Friday, October 27,
08:00-09:00, Hall A
On Wednesday, October 25 from 9:30-11:30am CEST, Merck will be hosting a press event briefing with members of the leadership team and lead investigators. A link to view this event will be available for media offsite, please contact ectrimspressevent@merckgroup.com for further information. Additionally, at 19:30pm CEST, Merck will be hosting a session highlighting data from a report which will be published during MSParis 17 entitled, Addressing the Socio-economic impact of Multiple Sclerosis on Women in Europe.
On Thursday, 26 October, Merck will also be hosting the annual Grant for Multiple Sclerosis Innovation (GMSI) Award Event at the Palais des Congres, Havane Theatre. The award, first launched at ECTRIMS in 2012, supports the advancement of science and medical research in the field of MS, and provides a grant of up to EUR1,000,000 per year to one or more selected research projects.
On Friday, 27 October, MS in the 21st Century (Merck sponsored initiative involving a joint Steering Group of international healthcare professionals and MS patient advocates) will host their first educational workshop titled 'Two monologues do not make a dialogue - Overcoming communications barriers between healthcare professionals and patient', to encourage better communication between healthcare professionals and people with MS. As part of this workshop, two new communication tools will also be launched: 'my/MS Priorities' and 'my/MS Commitments', both of which are designed to be used jointly with people with MS and their healthcare team to improve the quality and efficiency of clinical consultations and disease management.
For up-to-date information and activities during ECTRIMS 2017, follow Merck on Twitter (@MerckHealthcare or #AddressMS) or visit booth 08.
The following MAVENCLAD(®) and Rebif(®) global abstracts have been accepted for presentation at MSParis 2017, 7th Joint ECTRIMS-ACTRIMS Meeting:
MAVENCLAD (Cladribine Tablets) Presentations
--------------------------------------------
Title Lead Abstract/
Poster # Presentation Date/Time/Session
Author
--- ------
Effects of Cladribine
Tablets on CD4+ T Cell
Subsets in the ORACLE-
MS Study: Results from
an Analysis of
Lymphocyte Surface
Markers Stuve O P667 Poster Session 1
Thursday 26 October 2017
Time: 15:30-17:00
--- --- -----------------
Cladribine Tablets
Produce Selective and
Discontinuous
Reduction of B and T
Lymphocytes and
Natural Killer Cells
in Patients with Early
and Relapsing Multiple
Sclerosis (ORACLE-
MS,CLARITY and CLARITY
Extension) Stuve O P690
----------------------- ------- ----
Rates of Lymphopenia
Year-by-year in
Patients with
Relapsing Multiple
Sclerosis Treated and
Retreated with
Cladribine Tablets
3.5mg/kg Cook S P666
---------------------- ------ ----
Long-Term Lymphocyte
Counts in Patients
with Relapsing-
Remitting Multiple
Sclerosis (RRMS)
Treated with
Cladribine Tablets 3.5
mg/kg: Total
Lymphocytes, B and T
Cell Subsets Soelberg-Sorensen P P655
----------------------- ------------------- ----
Effects of Cladribine
Tablets on
Radiological Outcomes
in High Disease
Activity (HDA)
Subgroups of Patients
with Relapsing
Multiple Sclerosis
(RMS) in the CLARITY
Study Giovannoni G P1164 Poster Session 2
Friday 27 October 2017
Time: 15:30-17:00
Poster Session 2
Friday 27 October 2017
Time: 15:30-17:00
--- --- -----------------
Proportions of Patients
with Highly Active RMS
Achieving No Evidence
of Disease Activity
(NEDA) in Response to
Cladribine Tablets in
CLARITY Giovannoni G P1143
----------------------- ------------ -----
Investigation of
Cladribine Treatment
Rules in Subjects with
Relapsing-Remitting
Multiple Sclerosis
(RRMS) by means of
Modelling & Simulation Terranova N P912
----------------------- ----------- ----
Infections During
Periods of Grade 3 or
4 Lymphopenia in
Patients Taking
Cladribine Tablets 3.5
mg/kg: Data from an
Integrated Safety
Analysis Cook S P1142
----------------------- ------ -----
Innate Immune Cell
Counts in Patients
with Relapsing-
Remitting Multiple
Sclerosis (RRMS)
Treated with
Cladribine Tablets 3.5
mg/kg in CLARITY and
CLARITY Extension Soelberg-Sorensen P P1141
----------------------- ------------------- -----
An analysis of
malignancy risk in the
clinical development
programme of
cladribine tablets in
patients with
relapsing multiple
sclerosis (RMS) Galazka A P1878 Late-breaker
Poster Session 2
Friday 27 October 2017
Time: 15:30-17:00
--- --- -----------------
Pregnancy outcomes
during the clinical
development programme
of cladribine in
multiple sclerosis
(MS): an integrated
analysis of safety for
all exposed patients Galazka A P1874 Late-breaker
Poster Session 2
Friday 27 October 2017
Time: 15:30-17:00
--- --- -----------------
Rebif (interferon beta-1a) Presentations
----------------------------------------
Title Lead Author Abstract/
Poster # Presentation Date/Time/Session
--- ---
Disease Activity as
Assessed by the
MAGNIMS Score Predicts
Long-Term Clinical
Disease Activity Free
Status and Disability
Progression in
Patients Treated with
Subcutaneous
Interferon Beta-1a Sormani MP P770 Poster Session 1
Thursday 26 October 2017
Time: 15:30-17:00
Poster Session 1
Thursday 26 October 2017
Time: 15:30-17:00
--- --- -----------------
The Association between
Disease Activity and
Disability Progression
in Patients with
Relapsing-Remitting
Multiple Sclerosis Spelman T P348
----------------------- --------- ----
Clinical
Characteristics and
Treatment Patterns of
Relapsing-Remitting
Multiple Sclerosis
Patients with High
Disease Activity Spelman T P340
---------------------- --------- ----
Comparing patient and
healthcare
professional
perceptions on
multiple sclerosis
management and care
where do their
priorities differ?
Results from a
qualitative survey Rieckman P P814
--------------------- ---------- ----
Infertility Diagnosis
and Treatment in Women
With and Without
Multiple Sclerosis Houtchens MK AP356
----------------------- ------------ -----
Validation of MUSIQOL
among Arabic-speaking
MS Patients treated
with High dose INF-
1a sc injection New
Formulation Al Jumah M P821
---------------------- ---------- ----
RebiQoL: A telemedicine
patient support
program on health
related quality of
life and adherence in
MS patients treated
with Rebif Landtblom AM P826
----------------------- ------------ ----
Serum Neurofilament
light chain correlates
with disease activity
and predicts clinical
and MRI outcomes in MS Barro C P636
----------------------- ------- ----
Impact of the Presence
of Gadolinium-
Enhancing Lesions at
Baseline on No
Evidence of Disease
Activity Status in
Patients Treated with
Subcutaneous
Interferon Beta-1a: A
Post-Hoc Analysis of
REFLEXION Freedman M P1144 Poster Session 2
Friday 27 October 2017
Time: 15:30-17:00
Poster Session 2
Friday 27 October 2017
Time: 15:30-17:00
--- --- -----------------
Evolution of New
Lesions and its
Temporal Patterns in
Patients with
Clinically Isolated
Syndrome Treated with
Subcutaneous
Interferon Beta-1a Vrenken H P1025
---------------------- --------- -----
Using algorithms to
identify High Disease
Activity Relapsing-
Remitting Multiple
Sclerosis patients
using electronic
health record data
with natural language
processing Kamauu AW P877
---------------------- --------- ----
Using United States Kamauu AW
Integrated Delivery Patients
Network (IDN)
Electronic Health
Records (EHR)/Natural
Language Processing
(NLP)-Based
Algorithms to Identify
Relapses in Relapsing-
Remitting Multiple
Sclerosis (RRMS) P885
---------------------- --------- ----
Developing United
States Integrated
Delivery Network (IDN)
Claims-Based
Algorithms to Identify
Relapses in Relapsing-
Remitting Multiple
Sclerosis (RRMS)
Patients Kamauu AW P878
----------------------- --------- ----
Rates of Pregnancy in
Women With and Without
Multiple Sclerosis
Over Time Houtchens MK P890
----------------------- ------------ ----
Prevalence of
Comorbidities in
Patients With and
Without Multiple
Sclerosis by Age and
Sex: A US
Retrospective Claims
Database Analysis Kresa-Reahl K P941
--------------------- ------------- ----
Infertility Treatment
and Live Birth Rates
in Women With and
Without Multiple
Sclerosis Houtchens MK P891
--------------------- ------------ ----
An Evaluation of
Adherence Using Panel
Survey Data From
Patients With Multiple
Sclerosis Treated With
Subcutaneous
Interferon -1a or
Dimethyl Fumarate Perrin Ross A P1251
----------------------- ------------- -----
Real-World Assessment
of Relapse in Patients
With Multiple
Sclerosis Newly
Initiating scIFN 1a
Compared With Oral
Disease-Modifying
Drugs Bowen J P1245
----------------------- ------- -----
Interferon-beta and
regulatory cells:
evaluation of
treatment-induced
modulation of Treg,
Breg and CD56bright NK
cell levels in
multiple sclerosis
patients Martire S P1140
----------------------- --------- -----
Risk of stroke in
patients with multiple
sclerosis treated with
subcutaneous
interferon beta-1a Venkatesh S P1918 Late-breaker
Poster Session 2
Friday 27 October 2017
Time: 15:30-17:00
--- --- -----------------
Creating a healthcare
claims-based
adaptation of Kurtzke
Functional Systems
Scores for assessing
multiple sclerosis
severity and
progression Le Truong CTL EP1767 ePosters
---------------------- ------------- ------ --------
A mapping study to
compare the
educational offerings
for patients in the
fields of multiple
sclerosis and HIV in
Europe and Canada Rieckman P EP1838
---------------------- ---------- ------
Long-term real-life
retrospective analysis
on interferon 1-a
use in RRMS patients
in Finland Al Jumah M EP1687
----------------------- ---------- ------
Adherence, cognition
and behavioral
performance in
relapsing-remitting
MS (RRMS) patients
using the electronic
autoinjector
RetainSmartTM: 1 and 2
year follow-up from
the German multicenter
RETAINsmart study Rau D EP1692
----------------------- ----- ------
Cerebrospinal fluid
levels of
neurofilament light
chain, C-X-C ligand
motif 13, and
chitinase-3-like
protein 1 reflect
distinct pathological
processes in multiple
sclerosis Zanoni M EP1598
---------------------- -------- ------
Brain atrophy and
disease free status
over 3 years in
multiple sclerosis
patients under
interferon beta 1a
subcutaneous treatment Rojas JI EP1657
----------------------- -------- ------
Evobrutinib Presentations
-------------------------
Title Lead Author Abstract/
Poster # Presentation Date/Time/Session
--- ---
B cell-mediated
experimental CNS
autoimmunity is
modulated by
inhibition of Bruton's
tyrosine kinase Torke S 143 Oral Presentation
Parallel Session 8: Immune Cells in Injury and
Repair
Thursday 26 October 2017
14:00-15:30
--- --- -----------
Design of a Phase II
Dose Range Finding,
Efficacy and Safety
Study of the Bruton's
Tyrosine Kinase
Inhibitor Evobrutinib
(M2951) in Relapsing
Multiple Sclerosis
Patients Montalban X P675 Poster Session 1
Thursday 26 October 2017
Time: 15:30-17:00
--- --- -----------------
T cell mediated
experimental CNS
autoimmunity induced
by PLP in SJL mice is
modulated by
Evobrutinib (M2951) a
novel Bruton's
tyrosine kinase
inhibitor Boschert U P678
---------------------- ---------- ----
About MAVENCLAD(®)
MAVENCLAD(®) (cladribine tablets) is approved in the European Union for the treatment of highly active relapsing multiple sclerosis(*) (RMS). 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). MAVENCLAD(®) is currently under clinical investigation and not yet approved for the treatment for any use in the United States or Canada. 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.
The clinical development program for MAVENCLAD(®) 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 MAVENCLAD(®) as a monotherapy in patients with RRMS.
-- The CLARITY extension study: a two-year Phase III placebo-controlled
study following on from the CLARITY study, designed to evaluate the
safety and efficacy of MAVENCLAD(®) over an extended administration for
four years.
-- 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
MAVENCLAD(®) 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 MAVENCLAD(®) 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 Patients Who Have Participated in Cladribine Clinical
Studies) study: interim long-term follow-up data from the prospective
registry, PREMIERE, to evaluate the safety and efficacy of
MAVENCLAD(®). This includes more than 10,000 patient years of data with
over 2,700 patients included in the clinical trial program, and more
than 10 years of observation in some patients.
EU Indication
MAVENCLAD(®) (cladribine tablets) is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.
Important EU Safety Information
Contraindications:
MAVENCLAD(®) is contraindicated in patients with hypersensitivity to the active substance, human immunodeficiency virus (HIV), active chronic infection (tuberculosis or hepatitis), active malignancy, moderate to severe renal impairment (creatinine clearance <60 mL/min), and those who are pregnant and breast-feeding. MAVENCLAD(®) is also contraindicated in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy.
Special warnings and precautions for use:
The most clinically relevant adverse reactions were lymphopenia and herpes zoster.
Haematological monitoring
Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseline values have been observed in clinical studies, although these parameters usually remain within normal limits.
Additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile
Lymphocyte counts must be determined
-- before initiating MAVENCLAD(®) in year 1,
-- before initiating MAVENCLAD(®) in year 2,
-- 2 and 6 months after start of treatment in each treatment year. If the
lymphocyte count is below 500 cells/mm³, it should be actively
monitored until values increase again.
Infections
Cladribine can reduce the body's immune defence and may increase the likelihood of infections. HIV infection, active tuberculosis and active hepatitis must be excluded before initiation of cladribine.
The incidence of herpes zoster was increased in patients on cladribine. If lymphocyte counts drop below 200 cells/mm³, anti-herpes prophylaxis according to local standard practice should be considered during the time of grade 4 lymphopenia. Interruption or delay of MAVENCLAD(® )may be considered until proper resolution of the infection.
Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen.
In the clinical study data base of cladribine in MS (1,976 patients, 8,650 patient years) no case of PML has been reported. However, a baseline magnetic resonance imaging (MRI) should be performed before initiating MAVENCLAD(®) (usually within 3 months).
About Rebif(®)
Rebif(®) (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif(®) in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.
Rebif(®), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif(®) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area(+).
Rebif(®) can be administrated with the RebiSmart(®) electronic auto-injection device (not approved in the US), or with the RebiDose(®) single-use disposable pen, or the manual multidose injection pen RebiSlide(TM). Rebif(®) can also be administered with the autoinjector Rebiject II(®) or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.
In January 2012, the European commission approved the extension of the indication of Rebif(®) in early multiple sclerosis. The extension of the indication of Rebif(®) has not been submitted in the United States.
Rebif(®) should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif(®) with their doctors.
Rebif(®) (interferon beta-1a) is approved in the United States for relapsing forms of MS. RebiSmart(®), an electronic device for self-injection of Rebif(®), is also not approved in the United States. Cladribine Tablets is an investigational product and not approved for use in any indication in the United States.
(+)The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
About Evobrutinib
Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). It is an oral, highly selective inhibitor of Bruton's Tyrosine Kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently in Phase II studies.
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 2.3 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.
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About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of EUR 15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
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