Swiss healthcare giant Roche has unveiled powerful late-stage trial results for its experimental multiple sclerosis therapy fenebrutinib, highlighting a major advance in high-efficacy oral treatment for the disease.
The company announced that its Phase III FENhance 1 and 2 studies both met their primary endpoints, showing fenebrutinib—an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor—significantly reduced annualised relapse rates (ARR) in patients with relapsing multiple sclerosis (RMS) over 96 weeks.
In FENhance 1, relapse rates fell by 51.1% (p<0.001), while FENhance 2 showed an even stronger 58.5% reduction compared with teriflunomide. Roche said this translates to roughly one relapse every 17 years, more than half the rate seen with the comparator drug.
“These results underscore that fenebrutinib has potential as a high-efficacy oral treatment for RMS. Its unique mode of action may offer a differentiated profile by targeting dual drivers of MS within the central nervous system and periphery to address disease mechanisms underlying both relapsing and progressive disease biology,” said Jiwon Oh, Medical Director of the Barlo Multiple Sclerosis Program at St. Michael’s Hospital, University of Toronto.
“For the first time, a BTK inhibitor has demonstrated superiority in reducing relapses and formation of new brain lesions with comparable rates of liver enzyme elevations to a long-standing first-line medication in multiple Phase III RMS trials.”
Roche’s Chief Medical Officer Levi Garraway said: “The fenebrutinib data across three pivotal studies strongly support its potential to benefit people with both RMS and PPMS.” He added: “By more than doubling the time without relapses compared to teriflunomide, fenebrutinib may offer patients years of relapse-free living, thereby preserving both daily independence and long-term function.”
The treatment’s effect was consistent across patient subgroups, with the strongest benefits seen in those with more active inflammatory disease, including younger patients and those with recent diagnoses.
While disability progression results did not reach statistical significance, trends favoured fenebrutinib, with a 20% and 13% reduction in risk of confirmed disability progression across the two studies.
Safety data showed liver enzyme elevations were broadly comparable between treatment groups, though one Hy’s Law case occurred in each arm of FENhance 1. Serious adverse events were similar overall, though FENhance 2 showed a higher rate in the fenebrutinib group.
An imbalance in reported deaths was also observed across studies: eight deaths occurred in the fenebrutinib arms versus one in the teriflunomide arms during the reporting period, with causes ranging from infections to accidents and other serious medical complications.
Roche also pointed to earlier Phase III results in primary progressive MS, where fenebrutinib met its endpoint in the FENtrepid study versus Ocrevus, reinforcing its potential across both relapsing and progressive forms of the disease.
