- Fenebrutinib met its primary endpoint of non-inferiority to OCREVUS in reducing disability progression in PPMS.
- A 12% reduction in disability progression risk was observed compared to OCREVUS.
- Regulatory submission for fenebrutinib in PPMS and RMS is planned after the FENhance 1 readout, expected mid-2026.
- Adverse events in the fenebrutinib group were comparable to OCREVUS, with some transient liver enzyme elevations.
Study Results
Roche's Phase III FENtrepid study demonstrated that fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, met its primary endpoint of non-inferiority compared to OCREVUS in reducing disability progression in primary progressive multiple sclerosis (PPMS). Fenebrutinib showed a 12% reduction in the risk of disability progression, with curves separating as early as 24 weeks.
Functional Benefits
The study's primary endpoint included measures such as the Expanded Disability Status Scale (EDSS), timed 25-foot walk (T25FW), and nine-hole peg test (9HPT). Fenebrutinib showed a 26% reduction in the risk of worsening on the 9HPT, indicating potential benefits in upper limb function.
Regulatory Plans
Roche plans to submit fenebrutinib for regulatory approval in both PPMS and relapsing multiple sclerosis (RMS) following the Phase III FENhance 1 study readout, expected in mid-2026. This follows the successful completion of the FENtrepid study and the first of two Phase III RMS studies, FENhance 2.
Adverse Events
Adverse events in the fenebrutinib group were comparable to OCREVUS, with common issues including infections, nausea, and hemorrhage. Transient liver enzyme elevations were more frequent in the fenebrutinib group but resolved after discontinuation. Serious adverse events were reported in 19.1% of fenebrutinib patients, with 4.3% withdrawing from treatment.
