Merck Showcases Depth of MS Portfolio at ECTRIMS Supporting Commitment to Advancing MS Care

Merck, a leading science and technology company, today announced it will present 39 abstracts at the 38^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held October 26-28, 2022 in Amsterdam, the Netherlands. The breadth of data highlights the Company’s scientific leadership in multiple sclerosis (MS) and includes a presentation on a clinical trial with long-term data on Expanded Disability Status Scale (EDSS) scores in people with relapsing MS (RMS) treated with evobrutinib, an investigational agent, as well as new data demonstrating MAVENCLAD^® (cladribine tablets) improved Quality of Life (QoL) in people with highly active RMS over two years. Additionally, a two-year follow-up study showed the onset of action on the reduction of MRI lesions with MAVENCLAD being maintained from Month 2 through two years.

“Multiple sclerosis has a profound impact on quality of life and improving this through therapy is often the most important outcome for people living with MS,” said Gavin Giovannoni, Professor of Neurology, Queen Mary University of London. “The data presented at ECTRIMS further substantiate the therapeutic benefit of MAVENCLAD by improving Quality of Life measures over two years, combined with new evidence that the early effect on MRI lesions is maintained over that period.”

In the final analysis of the open-label, single-arm, multicenter, Phase IV CLARIFY-MS study, statistically significant (p≤0.0001) improvements from baseline were observed for Multiple Sclerosis Quality of Life-54 (MSQoL-54) physical and mental health composite scores (mean changes of 4.86 and 4.80, respectively; p<0.0001). Changes in MSQoL-54 composite scores were consistent across treatment naïve and prior disease-modifying treatment (DMT) subgroups. Annualized relapse rate was 0.13 in all patients (0.08 in patients who had not received DMT prior to receiving MAVENCLAD) and median EDSS was unchanged over two years. No new safety concerns emerged.

Also to be presented are new MRI outcomes data from the Phase IV MAGNIFY-MS study, which demonstrated an onset of action from Month 2 with sustained reduction in MRI lesion counts maintained out to two years in people with highly active RMS treated with MAVENCLAD. The proportion of lesion-free patients increased from 47% at baseline to 86.2% at the end of the study (Month 18–24). In the study, MRI lesions at baseline were compared over multiple time periods, from initial screening to Month 24. Over the two years, the benefit:risk profile of MAVENCLAD remained unchanged and in line with observations made during the clinical trial program.

Additionally, updated post-approval safety data will be presented based on an analysis of 56,300 patients who received MAVENCLAD post-approval, representing 95,664 patient-years of experience, as of July 2022. The study found the safety profile of MAVENCLAD is consistent with findings from the clinical development program and the CLARIFY-MS and MAGNIFY-MS studies.

“The breadth of our data at ECTRIMS exemplifies our commitment to pushing forward scientific innovation with the development of evobrutinib, while generating new, meaningful data to demonstrate the safety profile and effectiveness of MAVENCLAD,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology at Merck. “Our goal is to ensure people living with MS, and those who treat them, have the information they need to manage their MS today and in the future.”

Beyond the MAVENCLAD and evobrutinib data presented, Merck will have several Company events, along with additional data from its MS portfolio at ECTRIMS 2022.

Company activities at ECTRIMS 2022:

• “Connecting the dots: immune cells and CNS inflammation” co-chaired by Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Blizard Institute, Barts and the London School of Medicine and Dentistry, UK, and Celia Oreja-Guevara, MD, PhD, Hospital Clínico San Carlos, Madrid, Spain (October 26, 2022, 13:15-14:15 CEST)
• “New tools for new challenges in multiple sclerosis” chaired by Stephen Krieger, MD, Mount Sinai Hospital, New York, NY, USA (October 28, 2022, 14:15-15:15 CEST)
• Product Theater: Early Experience with MAVENCLAD by Ravi Dukkipati, MD, WellSpan Neurology, York, PA, USA

To keep up to date with our activities at ECTRIMS along with future data and information, visit merckneurology.com/newsroom or follow us on Twitter @MerckHealthcare and LinkedIn: Healthcare Business of Merck

Below is the full list of Merck-related abstracts accepted for presentation at ECTRIMS 2022:

Abstract Name	Authors	ID	Presentation Details
MAVENCLAD Poster Presentations
Improvements in Quality of Life Over 2 Years in Patients Treated With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: Final Analysis of CLARIFY-MS	Solari A, Montalban X, Lechner-Scott J, Piehl F, Brochet B, Langdon D, Hupperts R, Selmaj K, Havrdova EK, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, on behalf of the CLARIFY Investigators	P108	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Jeannette Lechner-Scott
Early Onset of Action and Sustained Efficacy of MRI Outcomes during Cladribine Tablets Treatment in Highly Active Relapsing Multiple Sclerosis: Results of the 2-year MAGNIFY-MS Study	De Stefano N, Achiron A, Barkhof F, Chan A, Derfuss T, Hodgkinson S, Leocani L, Montalban X, Prat A, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Smyk A, Gardner L	P717	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Nicola De Stefano
Updated Post-Approval Safety of Cladribine Tablets in the Treatment of Multiple Sclerosis, With Particular Reference to Liver Safety	Giovannoni G, Leist T, Jack D, Galazka A, Nolting A	P341	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Gavin Giovannoni
High Adherence and Minimal Delays of Year 2 Treatment in People with Multiple Sclerosis Treated with Cladribine Tablets: Results from Multi-Country Patient Support Programmes	Oh J, Ayer M, Alroughani R, Lemieux C, Morgan K, D’Eramo M, Vella T, Boshra A, de Souza S, Verdun di Cantogno E, Sabidó M	P727	Session: 2 Date: October 27, 2022 Time: 17:00 CEST Presenter: Jiwon Oh
Treatment Emergent Adverse Events Experienced Early and Transiently in the Treatment Course with Cladribine Tablets: Data from the CLEVER Real-World Study	Ziemssen T, Posevitz-Fejfar, Wagner T, Übler S, Richter J, Müller B, Penner I-K	P772	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Talf Ziemssen
Maven4: Phase IV Non-Interventional, Prospective, Spanish Multicenter Study to Evaluate Cladribine Tablets Long Term Effectiveness on Real-World Clinical Practice	Saiz A, Aladro Benito Y, Costa-Frossard F, Sánchez Magro I, Rodríguez Antigüedad A	P774	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Albert Saiz
Cladribine Protects SH-SY5Y Neuron-Like Cells from Oxidative Stress Conditions In Vitro	Eixarch H, Calvo-Barreiro L, Fissolo N, Boschert U, Comabella M, Montalban X, Espejo C	P784	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Herena Eixarch
Real-World Use of Cladribine Tablets (Completion Rates and Treatment Persistence) in Patients With Multiple Sclerosis in England: The CLARENCE Study	Brownlee W, Amin A, Herbert A, Ashton L	P762	Session: 2 Date: October 27, 2022 Time: 17:00 CEST Presenter: Wallace Brownlee
Decision-making Factors in Patient Choice to Initiate Treatment with Cladribine: A Preliminary Baseline Analysis From the STATURE Study	Allan M, Grech L, Cartwright A, Harding J, Mardan J, O’Maley J, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler E	P304	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Michelle Allan
Assessment of Treatment Satisfaction Across Oral DMTs for Multiple Sclerosis: a Preliminary Baseline Analysis from the STATURE Study.	Grech L, Allan M, Cartwright A, Harding J, Mardan J, O’Maley T, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler E	EP1086	Session: ePoster Date: October 26-28, 2022
A Real-World Study of Four-Year Follow Up Study of Patients Treated with Oral Cladribine From 2018-2022	O’Neill DTD, Sharma M, Dong G, Hodgkinson SJ	EP1132	Session: ePoster Date: October 26-28, 2022
A Study of Activated and Naïve T Regs and B Cell Subsets For 30 Months After the Use of Cladribine	Hodgkinson SJ, O’Neill DTD, Sharma M, Dong G, Verma ND, Al-atiyah R, Hall BM	P704	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Suzanna Hodgkinson
CLADCOMS - CLADribine Tablets Long-Term Control of MS – a Post-Marketing Investigator Driven Study	Fink K, Nilsson P, Alonso L, Sveningsson A, Gunnarsson M, Lange N, Ayad A, Vrethem M, Burman J, Lycke J, Piehl F	EP1060	Session: ePoster Date: October 26-28, 2022
Clinical Effectiveness and Safety of Cladribine Tablets for Patients Treated at least 12 Months in the Swedish Post-Market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10)	Rosengren V, Ekström E, Forsberg L, Hillert J, Nilsson P, Dahle C, Svenningsson A, Lycke J, Landtblom A-M, Burman J, Martin C, Sundström, Gunnarsson M, Piehl F, Olsson T	P728	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Linda Forsberg
SARS-CoV2 Exposure Rates and Serological Response of People Living With MS	Longinetti E, Asplund K, Kockum I, Englund S, Burman J, Fink K, Fogdell-Hahn A, Gunnarsson M, Hillert J, Langer-Gould A, Lycke J, Nilsson P, Salzer J, Svenningsson A, Mellergård J, Frisell T, Olsson T, Piehl F	P558	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Elisa Longinetti
COVID-19 Humoral and T-cell Mediated Vaccination Responses in People with Multiple Sclerosis	Vickaryous N, Rios F, Schalk L, Asardag AN, George K, Kang A, Baker D, Giovannoni G, Dobson R	P781	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Nikki Vickaryous
Differences Between Clinical Trials and “Real-World” Use of Disease Modifying Therapies: Insights from the UK OPTIMISE:MS Pharmacovigilance Study	Dobson R, Matthews P, Miller A, Pindoria J, Waddingham E	P763	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Ruth Dobson
Cladribine Treatment Exerts Specific Effects on Memory B Cell Immunoglobulin Repertoires in Multiple Sclerosis Patients	Ruschil C, Gabernet G, Kemmerer CL, Ziemann U, Nahnsen S, Kowarik MC	EP1115	Session: ePoster Date: October 26-28, 2022 Presenter: Christoph Ruschil
Cladribine Effects on T and B Cell Subsets and T Cell Reactivity in Multiple Sclerosis	Hansen RH, von Essen MR, Mahler MR, Cobanovic S, Binko TS, Sellebjerg F	P697	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Rikke Holm Hansen
Safety and Efficacy of Cladribine Therapy Following a Treatment with Anti-CD20 Compounds in Relapsing Multiple Sclerosis Patients: A Pilot Study	Sacco R, Disanto G, Pravatà E, Gobbi C, Zecca C	EP1068	Session: ePoster Date: October 26-28, 2022
Evobrutinib Poster Presentations
Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Maintains Lowered Serum Neurofilament Light Chain Levels Over 2.5 Years of Treatment, in Patients With Relapsing Multiple Sclerosis	Kuhle J, Kappos L, Montalban X, Benkert P, Li Y, Thangavelu K, Hyvert Y, Tomic D	EP1021	Session: ePoster Date: October 26-28, 2022 Presenter: Jens Kuhle
MRI and Clinical Outcomes of Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, in Relapsing Multiple Sclerosis Over 2.5 Years of the Open-label Extension to a Phase II Trial	Vermersch P, Arnold D, Wolinsky JS, Havrdova E, Kinkolykh A, Hyvert Y, Tomic D, Montalban X	P731	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Patrick Vermersch
Evobrutinib Exert a Therapeutic Action on EAE by Increasing the Peripheral and Central Classical Dendritic Cell Number and Maturation	Serrano-Regal MP, Calahorra L, Alonso-García I, Grenningloh R, Boschert U, Haselmayer P, Ortega MC, Machín-Díaz I, Camacho-Toledano C, García-Arocha J, Clemente D	P307	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Mari Paz Serrano-Regal
Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Acts on Microglia: Implications in the Treatment of Progressive Mechanisms in Multiple Sclerosis	Geladaris A, Torke S, Grenningloh R, Boschert U, Brück W, Weber MS	P693	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Anastasia Geladaris
B cells infiltrating the MS brain: from local maturation to targeting by evobrutinib	Bogers L, van Langelaar J, Rijvers L, Engelenburg HJ, Melief M-J, Wierenga-Wolf AF, Rip J, Blok KM, de Vries HE, Hendriks RW, Boschert U, Smolders J, van Luijn MM	P147	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Laurens Bogers
Immune response following mRNA COVID-19 vaccination in patients with multiple sclerosis treated with the Bruton’s tyrosine kinase inhibitor evobrutinib	Bar-Or A, Cross AH, Cunningham A, Hyvert Y, Seitzinger A, Drouin EE, Alexandri N, Tomic D, Montalban X	P1188	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Amit Bar-Or
Rebif® (interferon beta-1a) Subcutaneous Injection Poster Presentations
Exploring the Relationship Between Serum GDF-15 and Disease Stability in Patients with a First Clinical Demyelinating Event Treated with Subcutaneous Interferon β-1a or Placebo in the REFLEX Study	Coray M, Freedman MS, Barkhof F, Comi G, De Stefano N, Kappos L, Enz L, Seitzinger A, Jack D, Kuhle J, Mehling M	EP1027	Session: ePoster Date: October 26-28, 2022 Presenter: Mali Coray
Evolution of the RebiSmart® Autoinjector Device in Support of Adherence to Subcutaneous Interferon Beta-1a Therapy for Relapsing Multiple Sclerosis	Arnaud L, Keiser M, Henninger E, Piras F, Seitzinger A, Jack D, Le Masne Q	EP1079	Session: ePoster Date: October 26-28, 2022 Presenter: Dominic Jack
Validation of a Semi-Automated Method to Quantify Lesion Volume Changes in Multiple Sclerosis on 2D Proton Density- Weighted Images Using Subtraction Imaging	Mattiesing RM, Stel S, Mangroe AS, Brouwer I, Versteeg A, van Schijndel RA, Uitdehaag BMJ, Barkhof F, Vrenken H	P634	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Rozemarijn M Mattiesing
Expression of peripheral blood IFN-inducible genes predicts treatment outcome in patients with secondary progressive multiple sclerosis treated with IFN-beta-1a	Gurevich M, Zilkha-Falb R, Menascu S, Magalashvili D, Dolev M, Sonis P, Mandel M, Achiron A	P353	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Michael Gurevich
Non-Product Specific Poster Presentations
DISCOntinuation of disease-modifying therapies in MS (DISCOMS) Extension – Study Design and Baseline Demographics to Date	Engebretson E, Cutter G, Fox R, Kister I, Miller A, Morgan C, Seale R, Corboy JR	EP1089	Session: ePoster Date: October 26-28, 2022
Expert Opinion on the Use of Contraception in People with Multiple Sclerosis	Hillert J, Bove R, Haddad L, Hellwig K, Houtchens M, Magyari M, Mercki G, Montgomery S, Nappi R, Stenager E, Thompson H, Tulek Z, Verdun di Cantogno E, Simoni M	P080	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Jan Hillert
Single-Cell RNA Sequencing of Peripheral CD8+ T Cells of MS-Discordant Monozygotic Twins Reveals Disease-Associated Alterations In Immune Signaling	Kavaka V, Mutschler L, Eglseer K, Flierl-Hecht A, Kümpfel T, Hohlfeld R, Kerschensteiner M, Gerdes L.A, Beltran E	P159	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Vladyslav Kavaka
Caregiver Burden and Associated Factors Among Caregivers of Persons with Multiple Sclerosis: Application of a Specific Instrument	Vanotti S, Roman MS, Ferrandina F, Bauer J, Rosa R, Casas Parera I, Saladino ML, Caceres F	EP0864	Session: ePoster Date: October 26-28, 2022 Presenter: Sandra Vannoti
Evolutionarily Conserved Signatures of Microglia in Health and Disease	Salinas V, Manouchehri N, Hussain R, Stuve O	P131	Session: 1 Date: October 26, 2022 Time: 16:30- 18:30 CEST Presenter: Victor Salinas
Peripheral Blood Immune Markers Associated With Immunosenescence in Multiple Sclerosis and Healthy Controls	Carpentier Solorio Y, Daigneault A, Tastet O, Clénet M-L, Farzam-kia N, Levert A, Da Cal S, Clément W, Jamann H, Laurent C, Mamane VH, Ouedraogo O, Moratalla AC, Balthazard R, Lahav B, Prat A, Girard J-M, Duquette P, Rousseau M-C, Arbour N, Larochelle C	P545	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Catherine Larochelle
Chemerin Correlates with MS Progression Parameters and Affects Intracellular Metabolism in Human Microglia and Macrophages	Loonstra FC, van der Pol SM, Falize KF, van Heertum T, de Ruiter LR, Schoonheim MM, Killestein J, Uitdehaag BMJ, Kooij G, de Vries HE, Rijnsburger M	P551	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST Presenter: Merel Rijnsburger
Amyloid and some tau Proteinopathy are Observed in a Subset of Individuals with Multiple Sclerosis	Taga M, Duquesne L, Lee A, Sigalov A, Peralta Cruz F, De Jager P	P1204	Session: 2 Date: October 27, 2022 Time: 17:00- 19:00 CEST
Non-Product Specific Oral Presentations
Biological Roles of Myeloid Cell Subsets During CNS Inflammation	Manouchehri N, Victor, Hussain RZ, Stuve O	O124	Session: Young Scientific Investigators' Session 3: Long-term outcomes and safety Date: October 27, 2022 Time: 15:00- 16:00 CEST Presenter: Navid Manouchehri

About Evobrutinib
Evobrutinib is an oral, highly selective CNS-penetrant inhibitor of Bruton’s tyrosine kinase (BTK) in clinical development as a potential treatment for relapsing multiple sclerosis (RMS). It is the first BTK inhibitor to demonstrate clinical efficacy in the largest Phase II study with follow-up beyond three years as well as demonstrate an impact on early biomarkers of ongoing central inflammation that correlate with disease progression. Evobrutinib is designed to modulate B cell responses such as proliferation and antibody and cytokine release, as well as modulate macrophage/microglia activation. It significantly reduced SEL volume and levels of blood NfL, markers of ongoing central inflammation and neurodegeneration that predict long-term disability. Evobrutinib was optimized for efficacy through the most comprehensive BTK inhibitor dose-finding study in RMS which demonstrated 75mg twice-daily dosing achieves maximal efficacy across endpoints by sustaining BTK inhibition throughout the dosing interval (>95% BTK occupancy maintained in 98% of patients before next dose). It is currently under clinical investigation and is not approved for any use anywhere in the world.

About MAVENCLAD^®
MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery.

Because cladribine is cytotoxic, special handling and disposal instructions should be followed.

MAVENCLAD has been approved in over 80 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information.

About Rebif^®
Rebif (interferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is used to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.

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 potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).

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About Merck
Merck, a leading science and technology company, operates across life science, healthcare and electronics. Around 60,000 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 2021, Merck generated sales of € 19.7 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.

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