Roche’s Fenebrutinib Shows Strong Results in Phase III MS Trials

Roche has announced positive results from the pivotal Phase III FENhance 1 trial evaluating fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for Relapsing Multiple Sclerosis (RMS).

The study demonstrated a 51% reduction in annualised relapse rate (ARR) compared with teriflunomide after at least 96 weeks of treatment. These results align with the companion FENhance 2 trial, which previously showed a 59% reduction in relapse rate.

Both trials enrolled 1,497 adults with RMS in randomised, double-blind, multi-centre studies. Participants received either oral fenebrutinib twice daily or teriflunomide once daily.

Beyond relapse reduction, fenebrutinib also significantly decreased brain lesion activity measured through MRI scans and showed favourable trends in disability progression endpoints. After the double-blind phase, patients were offered entry into an open-label extension receiving fenebrutinib.

While the results are encouraging, safety monitoring continues. Investigators reported one death in the teriflunomide group and eight in the fenebrutinib group, with further evaluation ongoing.

05-03-2026