Genentech’s Fenebrutinib Shows Non-Inferiority to Ocrevus in Phase III PPMS Trial

Genentech, part of Roche, has reported positive Phase III results from the FENtrepid study evaluating fenebrutinib, an investigational Bruton’s tyrosine kinase inhibitor, in primary progressive multiple sclerosis (PPMS).

The trial met its primary endpoint, demonstrating non-inferiority to Ocrevus in delaying disability progression. Fenebrutinib reduced the risk of 12-week composite confirmed disability progression (cCDP12) by 12% compared with Ocrevus (hazard ratio 0.88), with treatment curves separating by week 24. The strongest benefit was observed in upper limb function, where risk of worsening fell by 26%.

Adverse events were comparable between groups. Serious adverse events occurred in 19.1% of fenebrutinib-treated patients versus 18.9% with Ocrevus, with discontinuation rates of 4.3% and 3.0%, respectively. Fatal events were reported in 1.4% and 0.2% of patients, none deemed treatment-related.

Regulatory submissions are planned following completion of the Phase III programme.

16-02-2026