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18.10.2017 – 12:36

Merck KGaA

Merck to Present New Data on MS Portfolio: Rebif, Mavenclad, and Evobrutinib at ECTRIMS 2017

Darmstadt, Germany (ots/PRNewswire)

Not intended for US/UK based media

Merck to Present New Data on MS Portfolio: Rebif, Mavenclad, and Evobrutinib at ECTRIMS 2017

- Important safety and immune cell analyses further characterize the 
  selective immune reconstitution approach of Mavenclad  
- Continued innovation with Rebif includes analysis of NEDA and use 
  of MAGNIMS criteria in predicting clinical outcomes out to 15 years
  
- Pre-clinical data for investigational evobrutinib highlight 
  potential role in patients with relapsing MS  
- A total of 40 abstracts will be presented by lead investigators   

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, 7th 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, October 26, 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, October 27, 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
Abstract/       
Presentation
Title                      Lead Author       Poster #        
Date/Time/Session
Effects of Cladribine
Tablets on CD4+ T Cell
Subsets in the ORACLE-MS                                     
Poster Session 1
Study: Results from an                                       
Thursday 26 October
Analysis of Lymphocyte                                       2017
Surface Markers            Stuve O           P667            
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  Soelberg-Sorensen
Subsets                    P                 P655




Effects of Cladribine                                        
Poster Session 2
Tablets on Radiological                                      
Friday 27 October 2017
Outcomes in High Disease                                     
Time: 15:30-17:00
Activity (HDA) Subgroups                                    
of Patients with Relapsing                                   
Poster Session 2
Multiple Sclerosis (RMS)                                     
Friday 27 October 2017
in the CLARITY Study       Giovannoni G      P1164           
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        Soelberg-
Extension                  Sorensen P        P1141



An analysis of malignancy                                    
Late-breaker
risk in the clinical                                         
Poster Session 2                                      
development programme of                                     
Friday 27 October 2017
cladribine tablets in                                        
Time: 15:30-17:00
patients with relapsing
multiple sclerosis (RMS)   Galazka A         P1878          



Pregnancy outcomes during                                    
Late-breaker
the clinical development                                     
Poster Session 2
programme of cladribine in                                   
Friday 27 October 2017
multiple sclerosis (MS):                                     
Time: 15:30-17:00
an integrated analysis of
safety for all exposed
patients                   Galazka A         P1874


Rebif (interferon beta-1a) Presentations
Abstract/       
Presentation
Title                      Lead Author       Poster #        
Date/Time/Session                                                    



Disease Activity as                                          
Poster Session 1                               
Assessed by the MAGNIMS                                      
Thursday 26 October
Score Predicts Long-Term                                     2017
Clinical Disease Activity                                    
Time: 15:30-17:00
Free Status and Disability                                   
Poster Session 1
Progression in Patients                                      
Thursday 26 October
Treated with Subcutaneous                                    2017
Interferon Beta-1a         Sormani MP        P770            
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-beta 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                                    
Poster Session 2                     
Gadolinium-Enhancing                                         
Friday 27 October 2017
Lesions at Baseline on No                                    
Time: 15:30-17:00
Evidence of Disease                                          
Poster Session 2
Activity Status in                                           
Friday 27 October 2017
Patients Treated with                                        
Time: 15:30-17:00
Subcutaneous Interferon
Beta-1a: A Post-Hoc
Analysis of REFLEXION      Freedman M        P1144          
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
Integrated Delivery
Network (IDN) Electronic
Health Records
(EHR)/Natural Language
Processing (NLP)-Based
Algorithms to Identify
Relapses in
Relapsing-Remitting
Multiple Sclerosis (RRMS)
Patients                   Kamauu AW         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 beta-1a or
Dimethyl Fumarate          Perrin Ross A     P1251
Real-World Assessment of
Relapse in Patients With
Multiple Sclerosis Newly
Initiating scIFNbeta1a
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                                   
Late-breaker
with multiple sclerosis                                      
Poster Session 2
treated with subcutaneous                                    
Friday 27 October 2017
interferon beta-1a         Venkatesh S       P1918           
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 beta1-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
Abstract/       
Presentation
Title                      Lead Author       Poster #        
Date/Time/Session                                                    


Oral
Presentation
B cell-mediated                                              
Parallel Session 8:                         
experimental CNS                                             
Immune Cells in Injury
autoimmunity is modulated                                    and 
Repair
by inhibition of Bruton's                                    
Thursday 26 October 2017
tyrosine kinase            Torke S           143             
14:00-15:30


Design of a Phase II Dose                                    
Poster Session 1
Range Finding, Efficacy                                      
Thursday 26 October 2017
and Safety Study of the                                      
Time: 15:30-17:00                        
Bruton's Tyrosine Kinase                                    
Inhibitor Evobrutinib
(M2951) in Relapsing
Multiple Sclerosis
Patients                   Montalban X       P675           
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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