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News & Trends - Pharmaceuticals

Merck unveils new data on long-term efficacy and safety in multiple sclerosis

Health Industry Hub | September 13, 2024 |

Pharma News: Merck Healthcare is set to highlight the long-term safety profile and sustained efficacy of Mavenclad (cladribine) for individuals with relapsing multiple sclerosis (RMS) at the upcoming 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), scheduled from September 18-20 in Copenhagen.

Among the 34 presentations, key findings from the Magnify-MS sub-studies will be showcased. These include data on Mavenclad’s impact on disability progression, central inflammation, and a focused oral presentation on immune reconstitution effects.

“The efficacy of Mavenclad has long been established through traditional endpoints from our original pivotal trials and beyond,” said Alexander Kulla, Senior Vice President & Medical Unit Head Neurology & Immunology at Merck.

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“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.”

Kulla also emphasized Mavenclad’s consistent safety profile, noting, “Mavenclad continues to demonstrate its consistent safety profile with sustained benefits, impacting the lives of more than 100,000 people living with MS.”

Data from the Magnify-MS extension, a Phase IV study, revealed that 79.2% of patients with highly active RMS achieved no evidence of disease activity (NEDA-3) during the fourth year of treatment. The annualised relapse rate (ARR) remained low overall at 0.09, with an even further reduction to 0.06 in treatment-naïve patients over four years.

The Clarify-MS extension also confirmed sustained benefits on cognition, MRI outcomes, and relapse rates four years post-initial treatment. Notably, 77.5% of patients showed improved or stable cognition scores based on the Symbol Digit Modalities Test (SDMT) cut-off.

Furthermore, a two-year Magnify-MS sub-study found low overall disability accrual in patients with highly active RMS treated with Mavenclad. A remarkable 93.7% of patients were free from progression independent of relapse activity (PIRA), with a notable reduction in PIRA among treatment-naïve patients (3.4% vs 8.5% in treatment-experienced patients), highlighting the benefits of early intervention.

The new data also builds on previous findings, showing Mavenclad’s ability to reduce or eliminate oligoclonal bands in cerebrospinal fluid (CSF). The latest two-year results indicate reductions in gene expression and protein levels of pro-inflammatory cytokines, offering insights into Mavenclad’s multifaceted effects on both peripheral blood and CSF.

These findings suggest that Mavenclad may facilitate immune reconstitution, potentially shifting the immune system to a less pathogenic state. Additional analyses of CSF proteomics and T and B cell transcriptomics further support the drug’s potential to reduce disease activity and progression in RMS patients, reinforcing the therapy’s role in preserving physical abilities and preventing relapses.

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