EMD Serono Unveils New MAVENCLAD® Four-Year Data Highlighting Benefits of Early Treatment and Sustained Efficacy Across Multiple Measures of Disease Activity

Not intended for UK-based media Phase IV studies demonstrate the consistent safety and high efficacy of MAVENCLAD on NEDA-3, MRI and cognition outcomes over four years New data on blood and CSF biomarkers show the impact of MAVENCLAD to promote immune cell reconstitution, while clinical data confirmed 93.7% of patients free from PIRA MAVENCLAD has now treated more than 100,000 patients globally, underscoring its trusted efficacy and safety profile EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced presentations showcasing the long-term safety profile, sustained efficacy data, and durable effect of MAVENCLAD® (cladribine) tablets in individuals with relapsing multiple sclerosis (RMS). Among 34 total MAVENCLAD presentations are data from several MAGNIFY-MS sub-studies demonstrating the impact of MAVENCLAD on disability progression, central inflammation, and an oral presentation on immune reconstitution effects. These data, along with six other company abstracts, will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place September 18-20 in Copenhagen. “The efficacy of MAVENCLAD has long been established through traditional endpoints from our original pivotal trials and beyond. Now, with additional measures of the impact on neuroinflammation and progression, we can reaffirm and further solidify its long-term efficacy position within the MS treatment landscape,” said Alexander Kulla, Senior Vice President & Medical Unit Head Neurology & Immunology at Merck KGaA, Darmstadt, Germany. “MAVENCLAD continues to demonstrate its consistent safety profile with sustained benefits, impacting the lives of more than 100,000 people living with MS." Results from the MAGNIFY-MS extension, a Phase IV study evaluating patients (n=219) on MAVENCLAD with highly active RMS, confirmed 79.2% of patients achieved no evidence of disease activity (NEDA-3) during Year 4 of the treatment. The annualized relapse rate (ARR) remained low overall (0.09) and was further reduced (0.06) in treatment-naïve patients over four years. Similarly, the CLARIFY-MS extension showed the sustained benefits in MAVENCLAD-treated patients (n=280) on cognition, in addition to MRI outcomes and relapses, four years after the initial treatment dose. Specific to cognition, 77.5% of patients had improved or stable scores at four years, based on the 8-point cut-off of the Symbol Digit Modalities Test (SDMT). In both studies, safety data aligned with the established profile from clinical trials. Two-year data from a MAGNIFY-MS sub-study found patients with highly active RMS treated with MAVENCLAD had low overall disability accrual, including low rates of progression independent of relapse activity (PIRA). At two years, rates for all disability measures were low overall with 93.7% of patients free from PIRA. The reduction of PIRA is especially notable in treatment-naïve patients (3.4% vs 8.5% in treatment-experienced patients), emphasizing the benefits of early treatment initiation with MAVENCLAD. Overall, these data suggest that MAVENCLAD is likely to preserve the physical abilities and prevent relapses in individuals with RMS, supporting the sustained efficacy and durable effect of MAVENCLAD. Building on prior data, which showed MAVENCLAD reduces or eliminates oligoclonal bands in the cerebrospinal fluid (CSF), new two-year data demonstrate reductions in gene expression and protein levels of markers associated with inflammation, including pro-inflammatory cytokines, providing insights into the potential multifaceted effect of MAVENCLAD in the peripheral blood and CSF. This data suggests that immune reconstitution following treatment with cladribine tablets may shift the immune system to a less pathogenic state. Analyses of CSF proteomics and T and B cell transcriptomics further substantiate the clinical findings, suggesting the potential of MAVENCLAD to reduce disease activity and progression in RMS patients. To view our 40 accepted abstracts and posters to be presented from across our MS portfolio at ECTRIMS, including innovative analyses of MAVENCLAD using artificial intelligence, please visit the Programme.

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