New Real-World MAVENCLAD® Data Show Sustained Effectiveness and Benefit on Quality-of-Life Measures in RMS Patients

• New data presented at ECTRIMS 2021 highlight improvement in measures of physical and mental health of patients with relapsing multiple sclerosis (RMS) after one year of treatment with MAVENCLAD^® (cladribine tablets)
• Late-breaking real-world data suggest sustained benefit of MAVENCLAD treatment on long-term mobility and disability status
• New independent data continue to show MAVENCLAD-treated patients receiving an mRNA COVID-19 vaccine mount a similar antibody response to that of the general population

(BUSINESS WIRE) -- Merck, a leading science and technology company, today announced new interim real-world data on MAVENCLAD^® (cladribine tablets) that show patients with relapsing multiple sclerosis (RMS) experienced a significant improvement in quality-of-life (QoL) scores after the first course of treatment in Year 1 with MAVENCLAD. Additionally, late-breaking real-world MAVENCLAD data evaluating long-term mobility and disability status suggested sustained benefit beyond the last treatment course and a reduced need for a wheelchair or ambulatory device among MAVENCLAD-treated patients. These data were presented at the 37^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

A new interim analysis from the open-label Phase IV CLARIFY-MS study demonstrated improvements in QoL measures in 426 patients with RMS early in the treatment course (Year 1). After completing half the recommended cumulative dose of MAVENCLAD over two years, improvements from baseline were observed for physical and mental health composite scores (nominal p<0.0001) as measured by the Quality of Life-54 questionnaire. Safety data were consistent with the safety profile seen in the MAVENCLAD clinical development program.

“Those living with MS know the effect of a treatment goes beyond what is shown in MRIs or in bloodwork. Many patients express that the impact on physical and mental well-being is just as important,” said Prof. Jeannette Lechner-Scott, PhD, FRACP, Senior Staff Specialist in the Department of Neurology and Conjoint Professor at the University of Newcastle, Australia. “The quality-of-life outcomes from the CLARIFY-MS study support that MAVENCLAD positively impacts these measures early in the treatment course.”

Also presented were late-breaking final data from the Phase IV CLASSIC-MS, a follow-up study, which showed that 90.0% of patients with RMS treated with cladribine tablets did not need to use a wheelchair or were not confined to bed (i.e., with an Expanded Disability Status Scale <7) after a median follow-up of 10.9 years (range 9.3-14.9). Additionally, 81.2% of cladribine tablets-treated patients did not require an ambulatory device. CLASSIC-MS investigated the long-term efficacy in 435 patients with RMS – 90.6% of whom were exposed to cladribine tablets during the CLARITY and CLARITY Extension trials. The study focused on long-term mobility and disability – two areas of importance as MS can cause problems with movement, balance and coordination that can worsen over time.

An independent study, presented by Prof. Adi Vaknin-Dembinsky, MD, PhD, Senior Neurologist, Hadassah Medical Center at the Hebrew University, Jerusalem, Israel, evaluated antibody response after a complete course of the Pfizer/BioNTech mRNA COVID-19 vaccine in healthy controls and patients with MS (untreated, or treated with MAVENCLAD or interferon beta-1a). Consistent with previously reported data, MAVENCLAD-treated patients, as well as those treated with interferon beta-1a, who received the Pfizer/BioNTech mRNA COVID-19 vaccine were found to mount a positive serology response (AU/mL >19), similar to that of healthy controls. Specifically, all patients with MS treated with MAVENCLAD (n=30) had a positive serology response against the spike protein two to three weeks after vaccination (mean=226.3±121.4). In the study, the shortest interval between vaccination and the last dose of MAVENCLAD was 12 weeks.

“The long-term MAVENCLAD outcomes presented at ECTRIMS 2021 suggest the potential to positively impact future mobility and disability status, supporting why MAVENCLAD should be considered a disease-modifying therapy of choice for appropriate adult patients living with RMS,” stated Danny Bar-Zohar, MD, Global Head of Development for the Healthcare business of Merck. “As new strains of COVID-19 push the pandemic onward and guidance recommends booster vaccinations, we are encouraged to have new data that continues to show MAVENCLAD-treated patients with RMS who received an mRNA COVID-19 vaccine have a similar antibody response to the general population.”

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<sup>®</sup> (interferon beta-1a) and MAVENCLAD<sup>®</sup> (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.

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