[Ad hoc announcement pursuant to Art. 53 LR] Roche's fenebrutinib confirms its potential as first and only BTK inhibitor for relapsing and primary progressive MS in third positive Phase III study (FENhance 1)

Core Insights - Roche announced that the pivotal Phase III study (FENhance 1) of fenebrutinib in relapsing multiple sclerosis (RMS) met its primary endpoint, showing a 51% reduction in annualized relapse rate (ARR) compared to teriflunomide over at least 96 weeks of treatment [1][8] - Secondary endpoints in both RMS studies indicated statistically significant reductions in brain lesions, with all progression endpoints showing favorable trends for fenebrutinib [1][8] Study Details - FENhance 1 and 2 are Phase III multicenter, randomized, double-blind studies evaluating fenebrutinib against teriflunomide in 1,497 adult patients with RMS, with participants randomized 1:1 for treatment over at least 96 weeks [7][8] - The primary endpoint is ARR, while secondary endpoints include MRI lesion counts and measures of disability progression [9] Safety Profile - Liver transaminase elevations in both RMS studies were comparable to teriflunomide, with one Hy's Law case in each treatment arm, both of which were asymptomatic and resolved after discontinuation [4] - In the FENhance studies, one fatal case was reported in the teriflunomide arm and eight in the fenebrutinib arms, with further analyses ongoing to understand these findings [5] Mechanism of Action - Fenebrutinib targets B cells and microglia to control acute inflammation and address chronic damage, designed to be a high-potency, reversible BTK inhibitor that can penetrate the central nervous system [6][11][12] Future Plans - Full data from the FENhance studies will be presented at the American Academy of Neurology Annual Meeting 2026 and submitted to regulatory authorities alongside data from the FENtrepid study [2]