Merck KGaA provides update on phase III results for evobrutinib in relapsing multiple sclerosis
Merck KGaA, a leading science and technology company, announced that its two Phase III EVOLUTION clinical trials (evolution RMS 1 and evolution RMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to oral teriflunomide (Aubagio) (0.11 vs. 0.11 in evolution RMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolution RMS 2, p=NS in both trials)
Of note, teriflunomide ARR values were lower than reported in other recent Phase III studies. The overall safety and tolerability profile was consistent with results from the previously reported Phase II trial.
The company will complete a full evaluation of the data from the EVOLUTION clinical trials and will work with investigators on the future presentation and publication of the results.
With evobrutinib, our aim was to address the significant unmet need of smoldering MS in addition to strong relapse control for people living with this condition,” said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck. “While we are very disappointed with the results, we continue to advance our strategy in healthcare with a focus on progressing our marketed portfolio and internal pipeline, complemented by external innovation, with the aim of bringing more medicines to patients, faster. I would like to sincerely thank all patients participating in the trials, their caregivers and our network of dedicated clinical investigators.
Congress coverage of ACTRIMS/AAN, ECTRIMS, MS Medical Grand Rounds, triMS, ECF and EAN on topics including quality of life in relapsing multiple sclerosis (RMS), safety and efficacy of therapies, pregnancy planning in MS and real-world data of disease-modifying therapies (DMTs).
Related news and insights
The FDA has granted regular approval to tepotinib (Tepmetko) for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations