EMD Serono Presents New MAVENCLAD ® Data Supporting Cognitive Function Benefits

In a post-hoc analysis, new data reveal evidence of cognitive benefit in RMS after the initial course of MAVENCLAD® (cladribine) tablets, with sustained cognitive improvement or stability observed at two years Additional findings support the sustained efficacy of MAVENCLAD in year three after treatment initiation, as shown by high rates of No Evidence of Disease Activity-3 (NEDA-3) ROCKLAND, Mass, February 29, 2024 – EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of two new post-hoc analyses of tertiary endpoints from the MAGNIFY-MS study, a Phase IV, prospective, open-label study evaluating the efficacy and safety of MAVENCLAD® (cladribine) tablets in highly active relapsing multiple sclerosis (RMS). The first presentation examines the stability or improvement in cognitive processing speed over a two-year period, suggesting the potential of MAVENCLAD to maintain or improve cognitive function in patients with highly active RMS. Additionally, interim findings from year three of the MAGNIFY-MS extension trial underscore the continued efficacy and safety profile of MAVENCLAD, which is consistent with earlier safety data. These data are being presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. The post-hoc analysis from 270 patients showed a clinically meaningful benefit in cognitive processing speed in patients treated with MAVENCLAD. Cognitive benefit was seen following the first treatment course and became more pronounced by month 18 when patients had received the full treatment course. At two years, the estimated rate of stability or sustained improvement was more than 95% with an 8-point score change on the Symbol Digit Modality Test (SDMT), a measure of cognitive processing speed. “Our decades of experience in multiple sclerosis have brought us clarity around the cognitive issues that affect over half of individuals with MS,” said Lori Lebson, PhD, Senior Vice President, North America Medical Affairs, EMD Serono. “Based on these findings from MAGNIFY-MS, where the majority of patients on MAVENCLAD experienced either cognitive improvement or stability at two years, we are optimistic about a future where the burden of cognitive changes in MS can be reduced.” Cognitive symptoms often have a profound impact on daily living and the quality of life in people living with MS. They can touch multiple aspects of a person’s life, such as employment, social life, including relationships, and even participating in their own healthcare decisions.1 Also being presented are the year three findings from an interim analysis of the extension trial of the MAGNIFY-MS study which showed sustained efficacy of MAVENCLAD, one year following completion of the two treatment courses. The No Evidence of Disease Activity-3 (NEDA-3) rates during year three were 85.99% for treatment naïve and 76.86% for those previously treated, based on the assessment of 219 patients. NEDA-3 status is defined as patients with no relapse, no 6-month Expanded Disability Status Scale (EDSS) progression and no T1 gadolinium-enhancing (Gd+) or active T2 lesions. The majority of patients (90.4%) were free of qualifying relapses and overall EDSS remained stable. Sustained improvements in MRI outcomes were seen: T1 Gd+ counts and annualized active T2 lesion counts showed a decrease from baseline to month 24 and month 36. These findings further support the continued benefits of MAVENCLAD following completion of the two-year treatment course.

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