Efficacy, Safety Signals

Roche’s Phase III data on fenebrutinib and Enspryng, the company’s two front‑line neurological assets, were disclosed on Tuesday. In the FENhance 1 and 2 studies, fenebrutinib reduced the annualized relapse rate in relapsing multiple sclerosis (RMS) by 51.1 % and 58.5 % versus teriflunomide over 96 weeks, a benefit that translates to an average of one relapse every 17 years. The drug also met key secondary endpoints, showing consistent reductions in brain disease activity and positive trends toward limiting disability progression. However, safety signals emerged: seven deaths occurred in the fenebrutinib arm compared with one death in the teriflunomide arm, with causes ranging from infections to an accidental fall. Liver enzyme elevations were comparable to teriflunomide, and no new safety signals were identified.