Merck, a leading science and technology company, today announced the presentation of new efficacy data from the Phase IV MAGNIFY-MS study on MAVENCLAD® (cladribine tablets) in patients with relapsing multiple sclerosis (RMS) which showed a rapid onset of action from end of Month 1 supported by changes in combined unique active (CUA) magnetic resonance imaging (MRI) lesions. The data also showed a significant reduction in mean T1 gadolinium-enhancing (Gd+) lesion counts.
“The MAGNIFY-MS results presented at ACTRIMS-ECTRIMS 2020 further substantiate the ability of MAVENCLAD to deliver early efficacy in patients with RMS,” said Prof. Nicola De Stefano, PhD, Professor of Neurology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy. “Knowing we can provide patients with a treatment option we feel confident can start working quickly and maintain efficacy over a longer period of time without the need for additional treatment or frequent monitoring is very exciting for the MS community.”
In the MAGNIFY-MS study, MRI lesions at baseline were compared over three time periods – Months 1–6, 2–6 and 3–6 of treatment. Data showed a rapid onset of action from end of Month 1, with CUA lesion counts significantly reduced in all study periods versus baseline (61% reduction for Months 1–6; 77% reduction for Months 2–6; 87% reduction for Months 3–6). Further, mean T1 Gd+ lesion counts, in particular, were significantly decreased from Month 2 onwards compared to baseline.
Additionally, updated post-approval safety data was presented based on an analysis of the first 18,463 patients who received MAVENCLAD post-approval, as of July 2020. The safety database analysis also provided a look at findings from 46 cases of confirmed or suspected COVID-19 in MAVENCLAD-treated patients (18 and 28, respectively), suggesting that patients treated with MAVENCLAD who acquire COVID-19 are not at an increased risk of severe outcomes. Data specifically showed the majority of patients had mild-to-moderate respiratory symptoms. Four patients were hospitalized and there were no deaths. Additional data on clinical outcomes in patients with COVID-19 infection will be available as part of the late-breaking and COVID-19 sessions from 25 September.
“The data presented exemplify our passion to dig deeper into MS research, continuing to learn more about how our existing treatments can impact those living with the disease, especially as they navigate MS management in the midst of a pandemic,” said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck. “We now have evidence showing an early onset of action and real-world data supporting the clinical trial findings that MAVENCLAD does not increase the risk of viral respiratory infections.”
Based on the analysis presented at the congress, rates of viral respiratory infections were low and typically non-serious; the pattern was consistent with that from the clinical development program. Crude incidences were: influenza, 0.68%; viral infection, 0.27%; and viral upper respiratory tract infection, 0.04%. The crude incidence rate of malignancy was much lower than that observed in the clinical trial program.