Merck Unveils Promising Four-Year Safety and Efficacy Data for Evobrutinib, Investigational BTK Inhibitor in RMS

27 February 2023 | Monday | News

Merck announced updated long-term efficacy and safety data for investigational evobrutinib that continue to show a favorable safety and tolerability profile, consistent with what was seen earlier
Image Source : Public Domain

Image Source : Public Domain

  • Data from the ongoing Phase II extension showed treatment benefits of evobrutinib were maintained over four years and remained consistent with the efficacy and safety profile seen in earlier data
  • Evobrutinib is an investigational highly-selective, oral, CNS-penetrant BTK inhibitor with the potential to become a safe and highly efficacious treatment option for people living with RMS

 Merck, a leading science and technology company, today announced updated long-term efficacy and safety data for investigational evobrutinib that continue to show a favorable safety and tolerability profile, consistent with what was seen earlier in the double-blind period (DBP) of the clinical trials. These data also continue to demonstrate its treatment benefit in reducing annualized relapse rates (ARR) over four years in people with relapsing multiple sclerosis (RMS). Data will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, taking place February 23-25.

Data from the ongoing Phase II open-label extension (OLE) trial of evobrutinib showed that treatment benefits were maintained over four years, with no new safety signals. Pooled ARR at week 228 of the OLE for all patients across the original DBP dosing groups was 0.13, with a further reduction seen in the period after switching from evobrutinib 75mg once-daily to 75mg twice-daily, from 0.19 to 0.10. For those receiving 75mg twice-daily dosing in the DBP, ARR was 0.11 at the end of DBP and 0.12 at week 228 of OLE. These data further support the twice-daily dosing currently being examined in Phase III clinical trials.

Overall, treatment emergent adverse events (TEAEs) were mild/moderate in the OLE, with 3.3% (n=7) of patients with RMS experiencing a serious TEAE. No new safety signals were seen in the OLE and evobrutinib continued to show consistent tolerability after up to four years of treatment. There was no dose dependent increase in TEAEs observed in patients who switched to twice-daily evobrutinib 75mg in the OLE.

“The MS community needs treatment options for both relapses and progression independent of relapse. This new long-term data complements previously presented data demonstrating evobrutinib's impact on novel markers indicative of progression independent of relapse, such as slowly expanding lesions. Together, these data highlight evobrutinib's potential to deliver a safe and highly efficacious option for people living with RMS,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology at Merck. “We look forward to presenting detailed results from our fully enrolled Phase III clinical trials in the near future.”

Additionally, at ACTRIMS, data will be presented that includes analyses of the CLARIFY-MS study, showing the potential of MAVENCLAD® (cladribine tablets) to improve outcomes in an impactful way for people living with RMS.

  • Participants maintained their employment status over the two years of the study, which included the COVID-19 pandemic, with 43.4% (n=209) of patients employed full-time at month 24, compared to 47.5% (n=229) at baseline.
  • Cognitive function remained stable over two years of treatment as measured at baseline, 12 and 24 months through the Brief International Cognitive Assessment for MS (BICAMS) battery, which is comprised of tests of mental processing speed and memory.

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