Dr Xavier Montalban Discusses Phase 3 evolutionRMS Trial Designs, Outcomes

Author(s):

While the results of evolutionRMS, comparing evobrutinib with teriflunomide, were negative, that "doesn't mean that evobrutinib is not working," said Xavier Montalban, MD, PhD, director of the Multiple Sclerosis Center of Catalonia (Cemcat).

Xavier Montalban, MD, PhD, director of the Multiple Sclerosis Center of Catalonia (Cemcat), discussed the designs and findings of the phase 3 evolutionRMS (relapsing multiple sclerosis) 1 and 2 trials, which he presented during the "Late-Breaking Research & Clinical Trials" session at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024 on March 2.

Also, although the study population consisted of patients from 52 different countries, Montalban explained that there were no variations in treatment responses.

Transcript

Can you explain the design of the phase 3 evolutionRMS 1 and 2 trials?

They are 2 identical phase 3 trials that were blind. We used them to compare teriflunomide against evobrutinib. More than 1200 patients were recruited in each of the trials. It was a large, large trial, and the duration was about 156 weeks.

Could you please summarize the findings of these trials?

The trial was essentially negative. Evobrutinib didn't show any positive results in relation to teriflunomide for annualized relapse rate, which was the primary end point, or any of the secondary end points, such as confirmed disability progression, confirmed disability improvement, or MRI [magnetic resonance imaging] parameters.

This doesn't mean that evobrutinib is not working. It does work as well as teriflunomide, but we have to say that the trial is definitely negative.

Considering the study population consisted of patients across 52 countries, were there variations in treatment responses or safety outcomes based on geographic regions or demographic factors?

Remember that we had 2 big events during the trial. One was the pandemic and the other was the Ukraine-Russia conflict. In the end, quite a large proportion of patients came from eastern Europe, especially from Ukraine and Russia, but the Merck team managed the situation very well. When you compare patients coming from those areas to patients coming from other areas in the world, there are no differences at all. I think there is no influence at all on the final result of the trials.