Roche (SIX: RO, ROG; OTCQX: RHHBY) is set to present new 48-week data on its investigational Bruton’s tyrosine kinase (BTK) inhibitor, fenebrutinib, at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place in Copenhagen, Denmark, on September 18, 2024. The Phase II FENopta open-label extension (OLE) study results show that fenebrutinib effectively maintains low disease activity and prevents disability progression in patients with relapsing multiple sclerosis (RMS) after one year of treatment.
“Fenebrutinib has demonstrated the ability to suppress almost all disease activity and prevent disability progression in multiple sclerosis patients after one year of treatment,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche. “If these findings are confirmed in ongoing Phase III trials, fenebrutinib could significantly enhance treatment options for those living with multiple sclerosis.”
During the OLE phase, 96% of patients treated with fenebrutinib were relapse-free after one year, with an annualized relapse rate (ARR) of 0.04. No disability progression was observed over the 48-week period, based on Expanded Disability Status Scale (EDSS) assessments.
Additionally, fenebrutinib reduced brain disease activity, as indicated by MRI scans. After 48 weeks, 99% of patients were free of T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation. Furthermore, there was a threefold reduction in the volume of T2 lesions, representing chronic disease burden, compared to the end of the study’s double-blind period (-0.33 cm³ vs. -0.11 cm³).
Fenebrutinib’s safety profile in the OLE phase remained consistent with earlier data. The most frequent adverse events (AEs) in over 5% of patients were urinary tract infections (8%), COVID-19 (7%), and pharyngitis (5%). Serious AEs occurred in 1% of patients. One patient experienced an asymptomatic elevation of alanine aminotransferase, which resolved after discontinuing treatment.
Currently, three Phase III trials are underway to further evaluate fenebrutinib’s impact on disease progression, including the FENhance 1 and 2 trials for RMS and the FENtrepid trial for primary progressive multiple sclerosis (PPMS). Results from these trials, expected by the end of 2025, will provide more comprehensive data on fenebrutinib’s efficacy across the multiple sclerosis spectrum.
