Roche’s Genentech announces fenebrutinib met its primary endpoint

Genentech, a member of the Roche Group (RHHBY), announced new late-breaking data from the Phase III FENtrepid study showing the investigational Bruton’s tyrosine kinase inhibitor fenebrutinib met its primary endpoint of non-inferiority compared to Ocrevus in reducing disability progression in patients with primary progressive multiple sclerosis, PPMS. Fenebrutinib showed a 12% reduction in the risk of disability progression compared to Ocrevus, the only approved medicine for PPMS, as measured by the time to onset of 12-week composite confirmed disability progression with curves separating as early as 24 weeks. A consistent treatment effect on cCDP12 was observed across patient subgroups and for the entire treatment duration. The cCDP12 primary endpoint included the confirmed disability progression based on the Expanded Disability Status Scale for functional disability, the timed 25-foot walk for walking speed and the nine-hole peg test for upper limb function. The strongest treatment effect was observed on the risk of worsening on the 9HPT by 26% compared to Ocrevus.