Roche to present data for fenebrutinib from Phase II FENopta OLE study

Roche will present new 48-week data for the investigational Bruton’s tyrosine kinase, BTK, inhibitor fenebrutinib from the Phase II FENopta open-label extension, OLE, study at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, ECTRIMS, in Copenhagen, Denmark on 18 September 2024. Results demonstrate that patients with relapsing multiple sclerosis, RMS, treated with fenebrutinib for up to one year maintained very low levels of disease activity and no disability progression. During the OLE period, 96% of patients treated with fenebrutinib were free of relapses at one year, with an annualised relapse rate of 0.04, and no change in disability over 48 weeks as measured by the Expanded Disability Status Scale. Fenebrutinib treatment suppressed disease activity in the brain as measured by MRI scans. At 48 weeks, 99% of patients were free of T1 gadolinium-enhancing lesions, markers of active inflammation. Over the 48 weeks of OLE with continued fenebrutinib treatment, there was three times more reduction in the volume of T2 lesions, which represent chronic disease burden, compared to the end of the double-blind period. The safety profile of fenebrutinib in the OLE was consistent with previously reported data. The most common adverse events in greater than5% of patients were urinary tract infection, COVID-1 and pharyngitis. Serious AEs occurred in one patient.