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.
This finding aligns with results from FENhance 2, which reported a 59% reduction.
Download sample pages of selected reports
Explore a selection of report samples we have handpicked for you. Get a preview of the insights inside. Download your free copy today.
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.
Primary 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.
Unlock up to 35% savings on GlobalData reports
Use the code at checkout in the report store
-
20% OFF
Buy 2 reports
Use code:
Bundle20
-
25% OFF
Buy 3 reports
Use code:
Bundle25
-
30% OFF
Buy 4 reports
Use code:
Bundle30
-
35% OFF
Buy 5+ reports
Use code:
Bundle35
Valid on all reports priced $995 and above. Cannot be combined with other offers.
Still deciding what will work best for your business?
Ask our experts for help.
Enquire before buying
