Genentech reports first relapsing multiple sclerosis trial met primary endpoint

Genentech, a member of the Roche (RHHBY), announced that the first Phase III of two pivotal, similarly-designed Phase III studies in patients with relapsing multiple sclerosis met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase inhibitor, significantly reduced the annualized relapse rate compared to teriflunomide over a period of at least 96 weeks of treatment. Additionally, the Phase III FENtrepid pivotal study evaluating fenebrutinib, compared with Ocrevus in patients with primary progressive multiple sclerosis, met its primary endpoint. The results showed that fenebrutinib was non-inferior compared to ocrelizumab, the only approved therapy in PPMS, as measured by a delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment. A numerical benefit for fenebrutinib compared to ocrelizumab was seen as early as week 24, and lasted throughout the observation period. Liver safety was consistent with previous fenebrutinib studies. Additional safety data is being further evaluated. The results of the second RMS Phase III trial are expected by the first half of 2026.