Merck Presents Four-Year MAVENCLAD® Data Showing Early Treatment Benefits and Continued Efficacy

DARMSTADT, Germany-- Merck, a renowned science and technology company, has unveiled a series of presentations highlighting the enduring safety, sustained efficacy, and long-lasting benefits of MAVENCLAD® (cladribine tablets) for individuals with relapsing multiple sclerosis (RMS). These findings are among 34 MAVENCLAD presentations featured at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) held from September 18-20 in Copenhagen. The presentations cover a range of topics, including data from the MAGNIFY-MS sub-studies, which evaluate the impact of MAVENCLAD on disability progression and central inflammation, as well as an oral presentation on immune reconstitution effects.

Alexander Kulla, Senior Vice President & Medical Unit Head Neurology & Immunology at Merck, emphasized the established efficacy of MAVENCLAD through traditional endpoints from pivotal trials. He stated, "With additional measures of the impact on neuroinflammation and progression, we can reaffirm and further solidify its long-term efficacy within the MS treatment landscape." Kulla noted that MAVENCLAD continues to demonstrate a consistent safety profile with sustained benefits, positively affecting over 100,000 people living with MS.

Key findings from the MAGNIFY-MS extension, a Phase IV study involving 219 patients with highly active RMS, revealed that 79.2% of patients achieved no evidence of disease activity (NEDA-3) during the fourth year of treatment. The annualized relapse rate (ARR) remained low overall (0.09), with an even lower rate (0.06) in treatment-naïve patients over four years. The CLARIFY-MS extension supported these findings, showing sustained benefits in 280 MAVENCLAD-treated patients regarding cognition, MRI outcomes, and relapses, four years post-initial treatment. Specifically, 77.5% of patients had improved or stable scores on the Symbol Digit Modalities Test (SDMT) at four years. Safety data across both studies aligned with the established profile from clinical trials.

Further two-year data from a MAGNIFY-MS sub-study demonstrated that patients with highly active RMS treated with MAVENCLAD experienced low overall disability accrual and low rates of progression independent of relapse activity (PIRA). Notably, 93.7% of patients were free from PIRA at two years, with treatment-naïve patients showing even lower rates (3.4%) compared to treatment-experienced patients (8.5%). These findings underscore the benefits of early treatment initiation with MAVENCLAD, suggesting its potential to preserve physical abilities and prevent relapses in RMS patients.

Building on prior research indicating that MAVENCLAD reduces or eliminates oligoclonal bands in the cerebrospinal fluid (CSF), new two-year data revealed reductions in gene expression and protein levels of markers associated with inflammation, including pro-inflammatory cytokines. This suggests that immune reconstitution following treatment may shift the immune system to a less pathogenic state. Analyses of CSF proteomics and T and B cell transcriptomics further support these clinical findings, indicating MAVENCLAD's potential to reduce disease activity and progression in RMS patients.

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 adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Due to its safety profile, MAVENCLAD is generally recommended for patients who have not had adequate responses to or cannot tolerate other MS treatments. The approved dose is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year. The mechanism of action involves cytotoxic effects on B and T lymphocytes, leading to lymphocyte depletion and subsequent recovery.

Merck, with its extensive legacy in neurology and immunology, aims to address unmet medical needs and improve the lives of patients with MS and other neuroinflammatory and immune-mediated diseases. The company operates across life science, healthcare, and electronics, employing around 63,000 people globally. In 2023, Merck generated sales of €21 billion in 65 countries, driven by a commitment to scientific exploration and responsible entrepreneurship.

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