Roche has reported that the pivotal Phase III FENhance 1 trial of its investigational Bruton’s tyrosine kinase (BTK) inhibitor, fenebrutinib, in relapsing multiple sclerosis (RMS), achieved the primary endpoint.
The trial results showed a reduction of 51% in annualised relapse rate (ARR) when compared to teriflunomide after a minimum of 96 weeks of treatment.
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This finding aligns with results from FENhance 2, which reported a 59% reduction.
Statistically significant reductions in brain lesions were observed across both studies, with all progression endpoints showing favourable trends for fenebrutinib.
The randomised, multi-centre, double-dummy, parallel-group, double-blind FENhance 1 and 2trials involved 1,497 adults with RMS.
Participants received either oral fenebrutinib twice daily or oral teriflunomide once daily for at least 96 weeks.
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By GlobalDataPrimary endpoint is the annualised relapse rate (ARR), and secondary goals encompass the overall count of T1-gadolinium-enhancing magnetic resonance imaging (MRI) lesions, the sum of new or enlarged T2-weighted MRI lesions, the duration until the start of a 12-week composite confirmed disability progression (cCDP12), and the time to a 24-week cCDP (cCDP24).
After the double-blind period, patients were offered an open-label extension phase with fenebrutinib.
FENhance 1 represents the conclusive study readout of the fenebrutinib pivotal clinical development programme for MS. This follows the favourable outcomes previously observed in FENhance 2 for RMS and in FENtrepid for primary progressive multiple sclerosis (PPMS).
Roche chief medical officer and global product development head Levi Garraway said: “These pivotal results, together with the earlier data, provide convincing evidence that fenebrutinib can become the first high-efficacy oral treatment for RMS and PPMS.
“Building on a decade of transforming MS treatment, we are committed to advancing innovation to one day allow people with MS to live a life without disability.”
Fatal cases were reported: one in the teriflunomide arm and eight in the fenebrutinib arm; while further investigations are ongoing.
In January 2026, Roche reported positive top line results from its Phase II trial in obesity, where once-weekly subcutaneous injection of CT-388 resulted in significant weight loss.
